Brentuksymab Vedotin i niwolumab z ipilimumabem lub bez w leczeniu pacjentów z nawracającym lub opornym na leczenie chłoniakiem Hodgkina
Badanie fazy I z kohortą rozszerzoną/randomizowane badanie fazy II skojarzenia ipilimumabu, niwolumabu i brentuksymabu Vedotin u pacjentów z nawracającym/opornym na leczenie chłoniakiem Hodgkina
This phase I/II trial studies the side effects and best dose of ipilimumab and nivolumab when given together with brentuximab vedotin, and how well they work in treating patients with Hodgkin lymphoma that has returned after a period of improvement (recurrent) or has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. It is not known whether giving brentuximab vedotin and nivolumab with or without ipilimumab may kill more cancer cells.
Przegląd badań
Status
Szczegółowy opis
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of the combinations of brentuximab vedotin and ipilimumab, brentuximab vedotin and nivolumab, and brentuximab vedotin, ipilimumab, and nivolumab. (Phase I) II. To evaluate the complete response (CR) rate for the regimens of brentuximab vedotin and nivolumab compared to brentuximab vedotin, ipilimumab, and nivolumab. (Phase II; adult cohort [aged >= 18 years]) III. To characterize the safety and toxicity of treatment combination in the pediatric population. (Phase II; pediatric cohort [aged 12-17 years])
SECONDARY OBJECTIVES:
I. To evaluate complete response (CR) rate, partial response (PR) rate and overall response rate (ORR), for the combinations of brentuximab vedotin and ipilimumab, brentuximab vedotin and nivolumab, and brentuximab vedotin, ipilimumab, and nivolumab. (Phase I) II. To evaluate the duration of remission (DOR) to these combinations and compare with the DOR achieved with the most recent prior systemic therapy. (Phase I) III. To evaluate the progression-free survival (PFS) and the overall survival (OS) in patients receiving the combination of brentuximab vedotin and ipilimumab, brentuximab vedotin and nivolumab, and brentuximab vedotin, ipilimumab, and nivolumab. (Phase I) IV. To evaluate the ORR, PR, and stable disease (SD) rate for the combinations of brentuximab vedotin and nivolumab and brentuximab vedotin, ipilimumab, and nivolumab. (Phase II) V. To evaluate the DOR to these combinations and compare with the DOR achieved with the most recent prior systemic therapy. (Phase II) VI. To evaluate the 5 year PFS and OS in patients receiving the combinations of brentuximab vedotin and nivolumab and brentuximab vedotin, ipilimumab, and nivolumab. (Phase II) VII. To further evaluate the safety and characterize the toxicity for the combinations of brentuximab vedotin and nivolumab, and brentuximab vedotin, ipilimumab, and nivolumab. (Phase II)
CORRELATIVE STUDY OBJECTIVES:
I. To evaluate the ability of these combinations to alter tumor specific T cell immunity. (Phase I) II. To evaluate the effects of these combinations on systemic immunity. (Phase I) III. To evaluate a panel of cytokine and T cell specific biomarkers from the peripheral blood as a potential immune signature of treatment response to therapy with these combinations for patients with relapsed/refractory Hodgkin lymphoma (HL). (Phase I) IV. To evaluate using gene expression profiling (GEP) a signature of response to these novel combinations of an antibody drug conjugate with immunomodulatory therapy. (Phase I) V. To evaluate the ability of these combinations to alter tumor specific T cell immunity, and circulating T cell phenotypes, in patients as a function of treatment response at multiple timepoints during therapy. (Phase II) VI. To evaluate peripheral blood cytokine profiles in responding and resistant patients at multiple timepoints during therapy. (Phase II) VII. To evaluate using GEP a signature of response versus (vs.) resistance to these novel combinations of an antibody drug conjugate with immunomodulatory therapy. (Phase II) VIII. To evaluate the influence of human gut microbiome dysbiosis on HL lymphomagenesis and the systemic immune response. (Phase II)
IMAGING CORRELATIVE STUDY OBJECTIVES:
I. To evaluate atypical response patterns with currently available response evaluation criteria. (Phase II) II. To correlate response evaluated using currently available response evaluation criteria with duration of response (PFS, event free survival [EFS], failure free survival [FFS]). (Phase II) III. To evaluate response patterns in different immunotherapy treatment schemes and correlate with historical data using chemotherapy. (Phase II) IV. To correlate imaging changes in all treatment schemes quantitatively with PFS. (Phase II)
EXPLORATORY OBJECTIVES:
I. Evaluate outcomes (CR, PFS) between patients with/without prior transplants. (Phase II) II. Evaluate outcomes (PFS, OS) between the patients who stay on treatment and do not go to transplant in both arms (the post auto and the few others who don't want transplant) vs the patients who go off for transplant. (Phase II) III. Evaluate outcomes (CR, PFS) in pediatric population (age 12 to < 18 years of age) vs. adult population. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of brentuximab vedotin, ipilimumab, and nivolumab followed by a phase II study.
PHASE I: Patients are assigned into 1 of 3 arms.
ARM I: Patients receive brentuximab vedotin intravenously (IV) over 90 minutes on day 1 of cycles 1-16 and ipilimumab IV over 30 minutes on day 1 of cycles 1-4, 8, 12, and 16. Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive brentuximab vedotin IV over 90 minutes on day 1 of cycles 1-16 and nivolumab IV over 30 minutes on day 1 of cycles 1-46. Treatment repeats every 21 days for up to 16 cycles and every 14 days beginning cycle 17 for up to 46 cycles in the absence of disease progression or unacceptable toxicity.
ARM III: Patients receive brentuximab vedotin IV over 90 minutes on day 1 of cycles 1-16, nivolumab IV over 30 minutes on day 1 of cycles 1-46, and ipilimumab IV over 30 minutes on day 1 every 12 weeks for up to 9 doses. Treatment repeats every 21 days for up to 16 cycles and every 14 days beginning cycle 17 for up to 46 cycles in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive brentuximab vedotin IV over 30 minutes on day 1 of cycles 1-16 and nivolumab IV over 90 minutes on day 1 of cycles 1-34. Treatment repeats every 21 days for up to 34 cycles in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive brentuximab vedotin IV over 90 minutes on day 1 of cycles 1-16, nivolumab IV over 30 minutes on day 1 of cycles 1-34, and ipilimumab IV over 30 minutes on day 1 every 12 weeks for up to 9 doses. Treatment repeats every 21 days for up to 34 cycles in the absence of disease progression or unacceptable toxicity.
All patients also undergo computed tomography (CT) or positron emission tomography (PET) scan throughout the trial. Patients undergo blood sample collection and may undergo tumor biopsy on study.
After completion of phase I study treatment, patients are followed up every 3 months for 1 year, then every 6 months for 2 years. After completion of phase II study treatment, patients are followed up for 10 years.
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 2
- Faza 1
Kontakty i lokalizacje
Lokalizacje studiów
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Alabama
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Birmingham, Alabama, Stany Zjednoczone, 35233
- University of Alabama at Birmingham Cancer Center
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Birmingham, Alabama, Stany Zjednoczone, 35233
- Children's Hospital of Alabama
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Alaska
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Anchorage, Alaska, Stany Zjednoczone, 98508
- Anchorage Associates in Radiation Medicine
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Anchorage, Alaska, Stany Zjednoczone, 99508
- Alaska Breast Care and Surgery LLC
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Anchorage, Alaska, Stany Zjednoczone, 99508
- Alaska Oncology and Hematology LLC
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Anchorage, Alaska, Stany Zjednoczone, 99508
- Alaska Women's Cancer Care
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Anchorage, Alaska, Stany Zjednoczone, 99508
- Anchorage Oncology Centre
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Anchorage, Alaska, Stany Zjednoczone, 99508
- Katmai Oncology Group
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Anchorage, Alaska, Stany Zjednoczone, 99508
- Providence Alaska Medical Center
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Anchorage, Alaska, Stany Zjednoczone, 99504
- Anchorage Radiation Therapy Center
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Fairbanks, Alaska, Stany Zjednoczone, 99701
- Fairbanks Memorial Hospital
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Arizona
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Kingman, Arizona, Stany Zjednoczone, 86401
- Kingman Regional Medical Center
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Phoenix, Arizona, Stany Zjednoczone, 85004
- Cancer Center at Saint Joseph's
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Arkansas
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Fort Smith, Arkansas, Stany Zjednoczone, 72903
- Mercy Hospital Fort Smith
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Hot Springs, Arkansas, Stany Zjednoczone, 71913
- CHI Saint Vincent Cancer Center Hot Springs
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California
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Antioch, California, Stany Zjednoczone, 94531
- Kaiser Permanente-Deer Valley Medical Center
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Arroyo Grande, California, Stany Zjednoczone, 93420
- PCR Oncology
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Arroyo Grande, California, Stany Zjednoczone, 93420
- Mission Hope Medical Oncology - Arroyo Grande
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Burbank, California, Stany Zjednoczone, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Dublin, California, Stany Zjednoczone, 94568
- Kaiser Permanente Dublin
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Fremont, California, Stany Zjednoczone, 94538
- Kaiser Permanente-Fremont
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Fresno, California, Stany Zjednoczone, 93720
- Kaiser Permanente-Fresno
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Fresno, California, Stany Zjednoczone, 93720
- Fresno Cancer Center
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Modesto, California, Stany Zjednoczone, 95356
- Kaiser Permanente-Modesto
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Oakland, California, Stany Zjednoczone, 94611
- Kaiser Permanente-Oakland
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Oakland, California, Stany Zjednoczone, 94611
- Kaiser Permanente Oakland-Broadway
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Orange, California, Stany Zjednoczone, 92868
- Children's Hospital of Orange County
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Palo Alto, California, Stany Zjednoczone, 94304
- Stanford Cancer Institute Palo Alto
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Rancho Cordova, California, Stany Zjednoczone, 95670
- Kaiser Permanente-Rancho Cordova Cancer Center
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Redwood City, California, Stany Zjednoczone, 94063
- Kaiser Permanente-Redwood City
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Richmond, California, Stany Zjednoczone, 94801
- Kaiser Permanente-Richmond
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Rohnert Park, California, Stany Zjednoczone, 94928
- Rohnert Park Cancer Center
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Roseville, California, Stany Zjednoczone, 95678
- The Permanente Medical Group-Roseville Radiation Oncology
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Roseville, California, Stany Zjednoczone, 95661
- Kaiser Permanente-Roseville
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Sacramento, California, Stany Zjednoczone, 95814
- Kaiser Permanente Downtown Commons
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Sacramento, California, Stany Zjednoczone, 95823
- Kaiser Permanente-South Sacramento
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Sacramento, California, Stany Zjednoczone, 95823
- South Sacramento Cancer Center
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Sacramento, California, Stany Zjednoczone, 95825
- Kaiser Permanente Sacramento Medical Center
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San Francisco, California, Stany Zjednoczone, 94115
- Kaiser Permanente-San Francisco
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San Francisco, California, Stany Zjednoczone, 94158
- UCSF Medical Center-Mission Bay
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San Jose, California, Stany Zjednoczone, 95119
- Kaiser Permanente-Santa Teresa-San Jose
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San Leandro, California, Stany Zjednoczone, 94577
- Kaiser Permanente San Leandro
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San Luis Obispo, California, Stany Zjednoczone, 93401
- Pacific Central Coast Health Center-San Luis Obispo
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San Rafael, California, Stany Zjednoczone, 94903
- Kaiser San Rafael-Gallinas
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San Rafael, California, Stany Zjednoczone, 94903
- Kaiser Permanente-San Rafael
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Santa Clara, California, Stany Zjednoczone, 95051
- Kaiser Permanente Medical Center - Santa Clara
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Santa Maria, California, Stany Zjednoczone, 93444
- Mission Hope Medical Oncology - Santa Maria
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Santa Rosa, California, Stany Zjednoczone, 95403
- Kaiser Permanente-Santa Rosa
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South San Francisco, California, Stany Zjednoczone, 94080
- Kaiser Permanente Cancer Treatment Center
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South San Francisco, California, Stany Zjednoczone, 94080
- Kaiser Permanente-South San Francisco
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Stockton, California, Stany Zjednoczone, 95210
- Kaiser Permanente-Stockton
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Vacaville, California, Stany Zjednoczone, 95688
- Kaiser Permanente Medical Center-Vacaville
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Vallejo, California, Stany Zjednoczone, 94589
- Kaiser Permanente-Vallejo
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Walnut Creek, California, Stany Zjednoczone, 94596
- Kaiser Permanente-Walnut Creek
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Colorado
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Aurora, Colorado, Stany Zjednoczone, 80012
- Rocky Mountain Cancer Centers-Aurora
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Aurora, Colorado, Stany Zjednoczone, 80012
- The Medical Center of Aurora
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Boulder, Colorado, Stany Zjednoczone, 80303
- Boulder Community Foothills Hospital
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Boulder, Colorado, Stany Zjednoczone, 80304
- Rocky Mountain Cancer Centers-Boulder
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Centennial, Colorado, Stany Zjednoczone, 80112
- Rocky Mountain Cancer Centers - Centennial
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Colorado Springs, Colorado, Stany Zjednoczone, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, Stany Zjednoczone, 80907
- Rocky Mountain Cancer Centers-Penrose
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Denver, Colorado, Stany Zjednoczone, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
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Denver, Colorado, Stany Zjednoczone, 80218
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
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Denver, Colorado, Stany Zjednoczone, 80220
- Rose Medical Center
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Denver, Colorado, Stany Zjednoczone, 80218
- Rocky Mountain Cancer Centers-Midtown
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Denver, Colorado, Stany Zjednoczone, 80220
- Rocky Mountain Cancer Centers-Rose
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Denver, Colorado, Stany Zjednoczone, 80204
- Denver Health Medical Center
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Denver, Colorado, Stany Zjednoczone, 80218
- Colorado Blood Cancer Institute
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Denver, Colorado, Stany Zjednoczone, 80204
- Cancer Center of Colorado at Sloan's Lake
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Denver, Colorado, Stany Zjednoczone, 80209
- The Women's Imaging Center
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Denver, Colorado, Stany Zjednoczone, 80206
- National Jewish Health-Main Campus
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Denver, Colorado, Stany Zjednoczone, 80220
- Western Surgical Care
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Denver, Colorado, Stany Zjednoczone, 80218
- Saint Joseph Hospital - Cancer Centers of Colorado
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Denver, Colorado, Stany Zjednoczone, 80210
- AdventHealth Porter
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Durango, Colorado, Stany Zjednoczone, 81301
- Mercy Medical Center
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Durango, Colorado, Stany Zjednoczone, 81301
- CommonSpirit Cancer Center Mercy
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Englewood, Colorado, Stany Zjednoczone, 80113
- Mountain Blue Cancer Care Center - Swedish
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Englewood, Colorado, Stany Zjednoczone, 80113
- Swedish Medical Center
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Englewood, Colorado, Stany Zjednoczone, 80113
- Rocky Mountain Cancer Centers - Swedish
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Golden, Colorado, Stany Zjednoczone, 80401
- Mountain Blue Cancer Care Center
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Golden, Colorado, Stany Zjednoczone, 80401
- National Jewish Health-Western Hematology Oncology
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Grand Junction, Colorado, Stany Zjednoczone, 81501
- Saint Mary's Hospital and Regional Medical Center
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Greeley, Colorado, Stany Zjednoczone, 80631
- Banner North Colorado Medical Center
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Lafayette, Colorado, Stany Zjednoczone, 80026
- Good Samaritan Hospital - Cancer Centers of Colorado
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Lakewood, Colorado, Stany Zjednoczone, 80228
- Rocky Mountain Cancer Centers-Lakewood
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Lakewood, Colorado, Stany Zjednoczone, 80228
- CommonSpirit Saint Anthony Hospital Cancer Center
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Littleton, Colorado, Stany Zjednoczone, 80120
- Rocky Mountain Cancer Centers-Littleton
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Littleton, Colorado, Stany Zjednoczone, 80122
- AdventHealth Littleton
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Lone Tree, Colorado, Stany Zjednoczone, 80124
- Sky Ridge Medical Center
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Lone Tree, Colorado, Stany Zjednoczone, 80124
- Rocky Mountain Cancer Centers-Sky Ridge
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Longmont, Colorado, Stany Zjednoczone, 80501
- Longmont United Hospital
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Longmont, Colorado, Stany Zjednoczone, 80501
- Rocky Mountain Cancer Centers-Longmont
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Loveland, Colorado, Stany Zjednoczone, 80539
- Banner North Colorado Medical Center - Loveland Campus
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Parker, Colorado, Stany Zjednoczone, 80138
- Rocky Mountain Cancer Centers-Parker
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Parker, Colorado, Stany Zjednoczone, 80138
- AdventHealth Parker
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Pueblo, Colorado, Stany Zjednoczone, 81008
- Rocky Mountain Cancer Centers - Pueblo
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Thornton, Colorado, Stany Zjednoczone, 80260
- Rocky Mountain Cancer Centers-Thornton
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Thornton, Colorado, Stany Zjednoczone, 80260
- National Jewish Health-Northern Hematology Oncology
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Wheat Ridge, Colorado, Stany Zjednoczone, 80401
- Intermountain Health Lutheran Hospital
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District of Columbia
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Washington D.C., District of Columbia, Stany Zjednoczone, 20010
- Children's National Medical Center
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Florida
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Fort Myers, Florida, Stany Zjednoczone, 33905
- Regional Cancer Center-Lee Memorial Health System
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Fort Myers, Florida, Stany Zjednoczone, 33908
- Golisano Children's Hospital of Southwest Florida
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St. Petersburg, Florida, Stany Zjednoczone, 33701
- Johns Hopkins All Children's Hospital
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Tampa, Florida, Stany Zjednoczone, 33606
- Tampa General Hospital
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Tampa, Florida, Stany Zjednoczone, 33607
- Saint Joseph's Hospital/Children's Hospital-Tampa
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30322
- Emory University Hospital/Winship Cancer Institute
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Atlanta, Georgia, Stany Zjednoczone, 30329
- Children's Healthcare of Atlanta - Arthur M Blank Hospital
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Hawaii
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Honolulu, Hawaii, Stany Zjednoczone, 96819
- Kaiser Permanente Moanalua Medical Center
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Idaho
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Boise, Idaho, Stany Zjednoczone, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, Stany Zjednoczone, 83712
- Saint Luke's Cancer Institute - Boise
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Caldwell, Idaho, Stany Zjednoczone, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, Stany Zjednoczone, 83814
- Kootenai Health - Coeur d'Alene
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Emmett, Idaho, Stany Zjednoczone, 83617
- Walter Knox Memorial Hospital
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Fruitland, Idaho, Stany Zjednoczone, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Stany Zjednoczone, 83642
- Idaho Urologic Institute-Meridian
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Meridian, Idaho, Stany Zjednoczone, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Stany Zjednoczone, 83687
- Saint Alphonsus Cancer Care Center-Nampa
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Nampa, Idaho, Stany Zjednoczone, 83687
- Saint Luke's Cancer Institute - Nampa
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Post Falls, Idaho, Stany Zjednoczone, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Sandpoint, Idaho, Stany Zjednoczone, 83864
- Kootenai Clinic Cancer Services - Sandpoint
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Twin Falls, Idaho, Stany Zjednoczone, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Alton, Illinois, Stany Zjednoczone, 62002
- OSF Saint Anthony's Health Center
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Aurora, Illinois, Stany Zjednoczone, 60504
- Rush-Copley Medical Center
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Bloomington, Illinois, Stany Zjednoczone, 61704
- Illinois CancerCare-Bloomington
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Canton, Illinois, Stany Zjednoczone, 61520
- Illinois CancerCare-Canton
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Carbondale, Illinois, Stany Zjednoczone, 62902
- Memorial Hospital of Carbondale
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Carterville, Illinois, Stany Zjednoczone, 62918
- SIH Cancer Institute
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Carthage, Illinois, Stany Zjednoczone, 62321
- Illinois CancerCare-Carthage
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Centralia, Illinois, Stany Zjednoczone, 62801
- Centralia Oncology Clinic
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Chicago, Illinois, Stany Zjednoczone, 60611
- Northwestern University
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Chicago, Illinois, Stany Zjednoczone, 60612
- University of Illinois
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Chicago, Illinois, Stany Zjednoczone, 60612
- Rush MD Anderson Cancer Center
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Danville, Illinois, Stany Zjednoczone, 61832
- Carle at The Riverfront
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Decatur, Illinois, Stany Zjednoczone, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Stany Zjednoczone, 62526
- Cancer Care Specialists of Illinois - Decatur
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Dixon, Illinois, Stany Zjednoczone, 61021
- Illinois CancerCare-Dixon
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Effingham, Illinois, Stany Zjednoczone, 62401
- Crossroads Cancer Center
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Effingham, Illinois, Stany Zjednoczone, 62401
- Carle Physician Group-Effingham
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Eureka, Illinois, Stany Zjednoczone, 61530
- Illinois CancerCare-Eureka
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Galesburg, Illinois, Stany Zjednoczone, 61401
- Western Illinois Cancer Treatment Center
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Galesburg, Illinois, Stany Zjednoczone, 61401
- Illinois CancerCare-Galesburg
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Joliet, Illinois, Stany Zjednoczone, 60435
- Duly Health and Care Joliet
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Kewanee, Illinois, Stany Zjednoczone, 61443
- Illinois CancerCare-Kewanee Clinic
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Macomb, Illinois, Stany Zjednoczone, 61455
- Illinois CancerCare-Macomb
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Mattoon, Illinois, Stany Zjednoczone, 61938
- Carle Physician Group-Mattoon/Charleston
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Mount Vernon, Illinois, Stany Zjednoczone, 62864
- SSM Health Good Samaritan
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O'Fallon, Illinois, Stany Zjednoczone, 62269
- Cancer Care Center of O'Fallon
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Ottawa, Illinois, Stany Zjednoczone, 61350
- Illinois CancerCare-Ottawa Clinic
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Pekin, Illinois, Stany Zjednoczone, 61554
- Illinois CancerCare-Pekin
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Peoria, Illinois, Stany Zjednoczone, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Stany Zjednoczone, 61615
- Illinois CancerCare-Peoria
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Peru, Illinois, Stany Zjednoczone, 61354
- Illinois CancerCare-Peru
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Peru, Illinois, Stany Zjednoczone, 61354
- Valley Radiation Oncology
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Princeton, Illinois, Stany Zjednoczone, 61356
- Illinois CancerCare-Princeton
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Springfield, Illinois, Stany Zjednoczone, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Stany Zjednoczone, 62702
- Springfield Clinic
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Springfield, Illinois, Stany Zjednoczone, 62781
- Springfield Memorial Hospital
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Swansea, Illinois, Stany Zjednoczone, 62226
- Southwest Illinois Health Services LLP
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Urbana, Illinois, Stany Zjednoczone, 61801
- Carle Cancer Center
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Urbana, Illinois, Stany Zjednoczone, 61801
- The Carle Foundation Hospital
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Washington, Illinois, Stany Zjednoczone, 61571
- Illinois CancerCare - Washington
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Yorkville, Illinois, Stany Zjednoczone, 60560
- Rush-Copley Healthcare Center
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Indiana
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Evansville, Indiana, Stany Zjednoczone, 47713
- Deaconess Clinic Downtown
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Indianapolis, Indiana, Stany Zjednoczone, 46202
- Indiana University/Melvin and Bren Simon Cancer Center
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Newburgh, Indiana, Stany Zjednoczone, 47630
- Chancellor Center for Oncology
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Iowa
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Clive, Iowa, Stany Zjednoczone, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, Stany Zjednoczone, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Council Bluffs, Iowa, Stany Zjednoczone, 51503
- Alegent Health Mercy Hospital
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Creston, Iowa, Stany Zjednoczone, 50801
- Greater Regional Medical Center
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Des Moines, Iowa, Stany Zjednoczone, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Stany Zjednoczone, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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West Des Moines, Iowa, Stany Zjednoczone, 50266
- Mercy Medical Center-West Lakes
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Kansas
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Garden City, Kansas, Stany Zjednoczone, 67846
- Central Care Cancer Center - Garden City
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Great Bend, Kansas, Stany Zjednoczone, 67530
- Central Care Cancer Center - Great Bend
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Kentucky
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Bardstown, Kentucky, Stany Zjednoczone, 40004
- CommonSpirit Saint Joseph Hospital - Bardstown
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Corbin, Kentucky, Stany Zjednoczone, 40701
- Commonwealth Cancer Center-Corbin
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Lexington, Kentucky, Stany Zjednoczone, 40504
- Saint Joseph Radiation Oncology Resource Center
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Lexington, Kentucky, Stany Zjednoczone, 40509
- CommonSpirit Saint Joseph Medical Center - East Lexington
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London, Kentucky, Stany Zjednoczone, 40741
- CommonSpirit Saint Joseph Hospital London
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Louisville, Kentucky, Stany Zjednoczone, 40202
- Jewish Hospital
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Louisville, Kentucky, Stany Zjednoczone, 40245
- UofL Health Medical Center Northeast
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Louisville, Kentucky, Stany Zjednoczone, 40215
- Saints Mary and Elizabeth Hospital
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Paducah, Kentucky, Stany Zjednoczone, 42003
- Mercy Health - Paducah Cancer Center
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Shepherdsville, Kentucky, Stany Zjednoczone, 40165
- Jewish Hospital Medical Center South
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Louisiana
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Baton Rouge, Louisiana, Stany Zjednoczone, 70805
- LSU Health Baton Rouge-North Clinic
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Baton Rouge, Louisiana, Stany Zjednoczone, 70809
- Louisiana Hematology Oncology Associates LLC
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Baton Rouge, Louisiana, Stany Zjednoczone, 70809
- Mary Bird Perkins Cancer Center
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Baton Rouge, Louisiana, Stany Zjednoczone, 70808
- Our Lady of The Lake
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Baton Rouge, Louisiana, Stany Zjednoczone, 70808
- Our Lady of the Lake Physician Group
-
Covington, Louisiana, Stany Zjednoczone, 70433
- Northshore Oncology Associates-Covington
-
Houma, Louisiana, Stany Zjednoczone, 70360
- Terrebonne General Medical Center
-
Houma, Louisiana, Stany Zjednoczone, 70360
- Oncology Center of The South Incorporated
-
-
Maryland
-
Baltimore, Maryland, Stany Zjednoczone, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
-
Baltimore, Maryland, Stany Zjednoczone, 21229
- Saint Agnes Hospital
-
Bethesda, Maryland, Stany Zjednoczone, 20889-5600
- Walter Reed National Military Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, Stany Zjednoczone, 02111
- Tufts Medical Center
-
-
Michigan
-
Port Huron, Michigan, Stany Zjednoczone, 48060
- Lake Huron Medical Center
-
Port Huron, Michigan, Stany Zjednoczone, 48060
- Huron Medical Center PC
-
-
Minnesota
-
Aitkin, Minnesota, Stany Zjednoczone, 56431
- Riverwood Healthcare Center
-
Brainerd, Minnesota, Stany Zjednoczone, 56401
- Essentia Health Saint Joseph's Medical Center
-
Deer River, Minnesota, Stany Zjednoczone, 56636
- Essentia Health - Deer River Clinic
-
Detroit Lakes, Minnesota, Stany Zjednoczone, 56501
- Essentia Health Saint Mary's - Detroit Lakes Clinic
-
Duluth, Minnesota, Stany Zjednoczone, 55805
- Essentia Health Cancer Center
-
Duluth, Minnesota, Stany Zjednoczone, 55805
- Essentia Health Saint Mary's Medical Center
-
Duluth, Minnesota, Stany Zjednoczone, 55805
- Miller-Dwan Hospital
-
Fergus Falls, Minnesota, Stany Zjednoczone, 56537
- Lake Region Healthcare Corporation-Cancer Care
-
Fosston, Minnesota, Stany Zjednoczone, 56542
- Essentia Health - Fosston
-
Hibbing, Minnesota, Stany Zjednoczone, 55746
- Essentia Health Hibbing Clinic
-
Park Rapids, Minnesota, Stany Zjednoczone, 56470
- Essentia Health - Park Rapids
-
Rochester, Minnesota, Stany Zjednoczone, 55905
- Mayo Clinic in Rochester
-
Sandstone, Minnesota, Stany Zjednoczone, 55072
- Essentia Health Sandstone
-
Virginia, Minnesota, Stany Zjednoczone, 55792
- Essentia Health Virginia Clinic
-
-
Missouri
-
Ballwin, Missouri, Stany Zjednoczone, 63011
- Mercy Oncology and Hematology - Clayton-Clarkson
-
Bolivar, Missouri, Stany Zjednoczone, 65613
- Central Care Cancer Center - Bolivar
-
Bonne Terre, Missouri, Stany Zjednoczone, 63628
- Parkland Health Center-Bonne Terre
-
Branson, Missouri, Stany Zjednoczone, 65616
- Cox Cancer Center Branson
-
Cape Girardeau, Missouri, Stany Zjednoczone, 63703
- Saint Francis Medical Center
-
Cape Girardeau, Missouri, Stany Zjednoczone, 63703
- Mercy Cancer Center - Cape Girardeau
-
Chesterfield, Missouri, Stany Zjednoczone, 63017
- Saint Luke's Hospital
-
City of Saint Peters, Missouri, Stany Zjednoczone, 63376
- Siteman Cancer Center at Saint Peters Hospital
-
Creve Coeur, Missouri, Stany Zjednoczone, 63141
- Siteman Cancer Center at West County Hospital
-
Farmington, Missouri, Stany Zjednoczone, 63640
- Parkland Health Center - Farmington
-
Jefferson City, Missouri, Stany Zjednoczone, 65109
- MU Health Care Goldschmidt Cancer Center
-
Joplin, Missouri, Stany Zjednoczone, 64804
- Freeman Health System
-
Joplin, Missouri, Stany Zjednoczone, 64804
- Mercy Hospital Joplin
-
Kansas City, Missouri, Stany Zjednoczone, 64108
- Children's Mercy Hospitals and Clinics
-
Rolla, Missouri, Stany Zjednoczone, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
-
Rolla, Missouri, Stany Zjednoczone, 65401
- Phelps Health Delbert Day Cancer Institute
-
Saint Joseph, Missouri, Stany Zjednoczone, 64506
- Heartland Regional Medical Center
-
Sainte Genevieve, Missouri, Stany Zjednoczone, 63670
- Sainte Genevieve County Memorial Hospital
-
Springfield, Missouri, Stany Zjednoczone, 65807
- CoxHealth South Hospital
-
Springfield, Missouri, Stany Zjednoczone, 65804
- Mercy Hospital Springfield
-
St Louis, Missouri, Stany Zjednoczone, 63110
- Washington University School of Medicine
-
St Louis, Missouri, Stany Zjednoczone, 63129
- Siteman Cancer Center-South County
-
St Louis, Missouri, Stany Zjednoczone, 63136
- Siteman Cancer Center at Christian Hospital
-
St Louis, Missouri, Stany Zjednoczone, 63131
- Missouri Baptist Medical Center
-
St Louis, Missouri, Stany Zjednoczone, 63109
- Mercy Infusion Center - Chippewa
-
St Louis, Missouri, Stany Zjednoczone, 63141
- Mercy Hospital Saint Louis
-
St Louis, Missouri, Stany Zjednoczone, 63128
- Mercy Hospital South
-
Sullivan, Missouri, Stany Zjednoczone, 63080
- Missouri Baptist Sullivan Hospital
-
Washington, Missouri, Stany Zjednoczone, 63090
- Mercy Hospital Washington
-
-
Montana
-
Anaconda, Montana, Stany Zjednoczone, 59711
- Community Hospital of Anaconda
-
Billings, Montana, Stany Zjednoczone, 59101
- Billings Clinic Cancer Center
-
Billings, Montana, Stany Zjednoczone, 59101
- Saint Vincent Healthcare
-
Billings, Montana, Stany Zjednoczone, 59102
- Saint Vincent Frontier Cancer Center
-
Bozeman, Montana, Stany Zjednoczone, 59715
- Bozeman Health Deaconess Hospital
-
Butte, Montana, Stany Zjednoczone, 59701
- Saint James Community Hospital and Cancer Treatment Center
-
Great Falls, Montana, Stany Zjednoczone, 59405
- Great Falls Clinic
-
Great Falls, Montana, Stany Zjednoczone, 59405
- Benefis Sletten Cancer Institute
-
Helena, Montana, Stany Zjednoczone, 59601
- Saint Peter's Community Hospital
-
Kalispell, Montana, Stany Zjednoczone, 59901
- Logan Health Medical Center
-
Missoula, Montana, Stany Zjednoczone, 59802
- Saint Patrick Hospital - Community Hospital
-
Missoula, Montana, Stany Zjednoczone, 59804
- Community Medical Center
-
-
Nebraska
-
Grand Island, Nebraska, Stany Zjednoczone, 68803
- Nebraska Cancer Specialists/Oncology Hematology West PC
-
Kearney, Nebraska, Stany Zjednoczone, 68847
- CHI Health Good Samaritan
-
Kearney, Nebraska, Stany Zjednoczone, 68845
- Fred and Pamela Buffett Cancer Center - Kearney
-
Lincoln, Nebraska, Stany Zjednoczone, 68510
- Saint Elizabeth Regional Medical Center
-
Omaha, Nebraska, Stany Zjednoczone, 68124
- Alegent Health Bergan Mercy Medical Center
-
Omaha, Nebraska, Stany Zjednoczone, 68122
- Alegent Health Immanuel Medical Center
-
Omaha, Nebraska, Stany Zjednoczone, 68130
- Alegent Health Lakeside Hospital
-
Omaha, Nebraska, Stany Zjednoczone, 68122
- Hematology and Oncology Consultants PC
-
Papillion, Nebraska, Stany Zjednoczone, 68046
- Midlands Community Hospital
-
-
Nevada
-
Carson City, Nevada, Stany Zjednoczone, 89703
- Carson Tahoe Regional Medical Center
-
Henderson, Nevada, Stany Zjednoczone, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
-
Henderson, Nevada, Stany Zjednoczone, 89052
- Cancer and Blood Specialists-Henderson
-
Henderson, Nevada, Stany Zjednoczone, 89052
- Las Vegas Cancer Center-Henderson
-
Henderson, Nevada, Stany Zjednoczone, 89074
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
-
Henderson, Nevada, Stany Zjednoczone, 89052
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
-
Henderson, Nevada, Stany Zjednoczone, 89074
- Las Vegas Urology - Green Valley
-
Henderson, Nevada, Stany Zjednoczone, 89074
- Las Vegas Urology - Pebble
-
Henderson, Nevada, Stany Zjednoczone, 89074
- Urology Specialists of Nevada - Green Valley
-
Henderson, Nevada, Stany Zjednoczone, 89074
- Oncology Las Vegas - Henderson
-
Las Vegas, Nevada, Stany Zjednoczone, 89144
- Summerlin Hospital Medical Center
-
Las Vegas, Nevada, Stany Zjednoczone, 89109
- Sunrise Hospital and Medical Center
-
Las Vegas, Nevada, Stany Zjednoczone, 89102
- OptumCare Cancer Care at Charleston
-
Las Vegas, Nevada, Stany Zjednoczone, 89106
- Radiation Oncology Centers of Nevada Central
-
Las Vegas, Nevada, Stany Zjednoczone, 89119
- Radiation Oncology Centers of Nevada Southeast
-
Las Vegas, Nevada, Stany Zjednoczone, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
-
Las Vegas, Nevada, Stany Zjednoczone, 89128
- OptumCare Cancer Care at MountainView
-
Las Vegas, Nevada, Stany Zjednoczone, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
-
Las Vegas, Nevada, Stany Zjednoczone, 89144
- Comprehensive Cancer Centers of Nevada - Town Center
-
Las Vegas, Nevada, Stany Zjednoczone, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
-
Las Vegas, Nevada, Stany Zjednoczone, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Stany Zjednoczone, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
-
Las Vegas, Nevada, Stany Zjednoczone, 89102
- University Medical Center of Southern Nevada
-
Las Vegas, Nevada, Stany Zjednoczone, 89106
- Cancer and Blood Specialists-Shadow
-
Las Vegas, Nevada, Stany Zjednoczone, 89109
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
-
Las Vegas, Nevada, Stany Zjednoczone, 89113
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
-
Las Vegas, Nevada, Stany Zjednoczone, 89128
- Cancer and Blood Specialists-Tenaya
-
Las Vegas, Nevada, Stany Zjednoczone, 89128
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
-
Las Vegas, Nevada, Stany Zjednoczone, 89148-2405
- Las Vegas Cancer Center-Medical Center
-
Las Vegas, Nevada, Stany Zjednoczone, 89149
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
-
Las Vegas, Nevada, Stany Zjednoczone, 89128
- Ann M Wierman MD LTD
-
Las Vegas, Nevada, Stany Zjednoczone, 89074
- Las Vegas Urology - Pecos
-
Las Vegas, Nevada, Stany Zjednoczone, 89102
- Desert West Surgery
-
Las Vegas, Nevada, Stany Zjednoczone, 89103
- Hope Cancer Care of Nevada
-
Las Vegas, Nevada, Stany Zjednoczone, 89106
- Urology Specialists of Nevada - Central
-
Las Vegas, Nevada, Stany Zjednoczone, 89113
- Las Vegas Prostate Cancer Center
-
Las Vegas, Nevada, Stany Zjednoczone, 89113
- Las Vegas Urology - Sunset
-
Las Vegas, Nevada, Stany Zjednoczone, 89128
- Las Vegas Urology - Cathedral Rock
-
Las Vegas, Nevada, Stany Zjednoczone, 89128
- Las Vegas Urology - Smoke Ranch
-
Las Vegas, Nevada, Stany Zjednoczone, 89128
- Urology Specialists of Nevada - Northwest
-
Las Vegas, Nevada, Stany Zjednoczone, 89169
- University Cancer Center
-
Las Vegas, Nevada, Stany Zjednoczone, 89113
- Urology Specialists of Nevada - Southwest
-
Las Vegas, Nevada, Stany Zjednoczone, 89128
- Oncology Las Vegas - Tenaya
-
Las Vegas, Nevada, Stany Zjednoczone, 89183
- OptumCare Cancer Care at Fort Apache
-
Pahrump, Nevada, Stany Zjednoczone, 89048
- Hope Cancer Care of Nevada-Pahrump
-
Reno, Nevada, Stany Zjednoczone, 89502
- Renown Regional Medical Center
-
Reno, Nevada, Stany Zjednoczone, 89503
- Saint Mary's Regional Medical Center
-
Reno, Nevada, Stany Zjednoczone, 89509
- Radiation Oncology Associates
-
-
New Jersey
-
Hackensack, New Jersey, Stany Zjednoczone, 07601
- Hackensack University Medical Center
-
Lakewood, New Jersey, Stany Zjednoczone, 08701
- Monmouth Medical Center Southern Campus
-
Long Branch, New Jersey, Stany Zjednoczone, 07740
- Monmouth Medical Center
-
Morristown, New Jersey, Stany Zjednoczone, 07960
- Morristown Medical Center
-
New Brunswick, New Jersey, Stany Zjednoczone, 08903
- Rutgers Cancer Institute of New Jersey
-
New Brunswick, New Jersey, Stany Zjednoczone, 08903
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
-
-
New Mexico
-
Albuquerque, New Mexico, Stany Zjednoczone, 87106
- University of New Mexico Cancer Center
-
-
New York
-
Albany, New York, Stany Zjednoczone, 12208
- Albany Medical Center
-
Buffalo, New York, Stany Zjednoczone, 14263
- Roswell Park Cancer Institute
-
New York, New York, Stany Zjednoczone, 10065
- Memorial Sloan Kettering Cancer Center
-
New York, New York, Stany Zjednoczone, 10029
- Mount Sinai Hospital
-
New York, New York, Stany Zjednoczone, 10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
-
New York, New York, Stany Zjednoczone, 10065
- NYP/Weill Cornell Medical Center
-
New York, New York, Stany Zjednoczone, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
-
Stony Brook, New York, Stany Zjednoczone, 11794
- Stony Brook University Medical Center
-
Syracuse, New York, Stany Zjednoczone, 13210
- State University of New York Upstate Medical University
-
The Bronx, New York, Stany Zjednoczone, 10467
- Montefiore Medical Center - Moses Campus
-
-
North Carolina
-
Chapel Hill, North Carolina, Stany Zjednoczone, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Charlotte, North Carolina, Stany Zjednoczone, 28203
- Carolinas Medical Center/Levine Cancer Institute
-
Clinton, North Carolina, Stany Zjednoczone, 28328
- Southeastern Medical Oncology Center-Clinton
-
Goldsboro, North Carolina, Stany Zjednoczone, 27534
- Southeastern Medical Oncology Center-Goldsboro
-
Goldsboro, North Carolina, Stany Zjednoczone, 27534
- Wayne Memorial Hospital
-
Jacksonville, North Carolina, Stany Zjednoczone, 28546
- Southeastern Medical Oncology Center-Jacksonville
-
Jacksonville, North Carolina, Stany Zjednoczone, 28546
- Onslow Memorial Hospital
-
-
North Dakota
-
Fargo, North Dakota, Stany Zjednoczone, 58103
- Essentia Health Cancer Center-South University Clinic
-
Jamestown, North Dakota, Stany Zjednoczone, 58401
- Essentia Health - Jamestown Clinic
-
-
Ohio
-
Akron, Ohio, Stany Zjednoczone, 44308
- Children's Hospital Medical Center of Akron
-
Cincinnati, Ohio, Stany Zjednoczone, 45229
- Cincinnati Children's Hospital Medical Center
-
Cincinnati, Ohio, Stany Zjednoczone, 45220
- Good Samaritan Hospital - Cincinnati
-
Cincinnati, Ohio, Stany Zjednoczone, 45242
- Bethesda North Hospital
-
Cincinnati, Ohio, Stany Zjednoczone, 45247
- TriHealth Cancer Institute-Westside
-
Cincinnati, Ohio, Stany Zjednoczone, 45255
- TriHealth Cancer Institute-Anderson
-
Cleveland, Ohio, Stany Zjednoczone, 44109
- MetroHealth Medical Center
-
Columbus, Ohio, Stany Zjednoczone, 43205
- Nationwide Children's Hospital
-
-
Oklahoma
-
Lawton, Oklahoma, Stany Zjednoczone, 73505
- Cancer Centers of Southwest Oklahoma Research
-
Oklahoma City, Oklahoma, Stany Zjednoczone, 73104
- University of Oklahoma Health Sciences Center
-
Oklahoma City, Oklahoma, Stany Zjednoczone, 73120
- Mercy Hospital Oklahoma City
-
Tulsa, Oklahoma, Stany Zjednoczone, 74146
- Oklahoma Cancer Specialists and Research Institute-Tulsa
-
-
Oregon
-
Baker City, Oregon, Stany Zjednoczone, 97814
- Saint Alphonsus Cancer Care Center-Baker City
-
Bend, Oregon, Stany Zjednoczone, 97701
- Saint Charles Health System
-
Clackamas, Oregon, Stany Zjednoczone, 97015
- Clackamas Radiation Oncology Center
-
Clackamas, Oregon, Stany Zjednoczone, 97015
- Providence Cancer Institute Clackamas Clinic
-
Coos Bay, Oregon, Stany Zjednoczone, 97420
- Bay Area Hospital
-
Newberg, Oregon, Stany Zjednoczone, 97132
- Providence Newberg Medical Center
-
Ontario, Oregon, Stany Zjednoczone, 97914
- Saint Alphonsus Cancer Care Center-Ontario
-
Oregon City, Oregon, Stany Zjednoczone, 97045
- Providence Willamette Falls Medical Center
-
Portland, Oregon, Stany Zjednoczone, 97213
- Providence Portland Medical Center
-
Portland, Oregon, Stany Zjednoczone, 97225
- Providence Saint Vincent Medical Center
-
Redmond, Oregon, Stany Zjednoczone, 97756
- Saint Charles Health System-Redmond
-
-
Pennsylvania
-
Hershey, Pennsylvania, Stany Zjednoczone, 17033-0850
- Penn State Milton S Hershey Medical Center
-
Philadelphia, Pennsylvania, Stany Zjednoczone, 19111
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- Children's Hospital of Philadelphia
-
Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- University of Pennsylvania/Abramson Cancer Center
-
-
South Carolina
-
Boiling Springs, South Carolina, Stany Zjednoczone, 29316
- Prisma Health Cancer Institute - Spartanburg
-
Columbia, South Carolina, Stany Zjednoczone, 29203
- Prisma Health Richland Hospital
-
Easley, South Carolina, Stany Zjednoczone, 29640
- Prisma Health Cancer Institute - Easley
-
Greenville, South Carolina, Stany Zjednoczone, 29605
- Prisma Health Cancer Institute - Faris
-
Greenville, South Carolina, Stany Zjednoczone, 29607
- Saint Francis Cancer Center
-
Greenville, South Carolina, Stany Zjednoczone, 29615
- Prisma Health Cancer Institute - Eastside
-
Greenville, South Carolina, Stany Zjednoczone, 29605
- Prisma Health Cancer Institute - Butternut
-
Greenville, South Carolina, Stany Zjednoczone, 29601
- Saint Francis Hospital
-
Greenville, South Carolina, Stany Zjednoczone, 29605
- BI-LO Charities Children's Cancer Center
-
Greenville, South Carolina, Stany Zjednoczone, 29605
- Prisma Health Greenville Memorial Hospital
-
Greer, South Carolina, Stany Zjednoczone, 29650
- Prisma Health Cancer Institute - Greer
-
Seneca, South Carolina, Stany Zjednoczone, 29672
- Prisma Health Cancer Institute - Seneca
-
-
Tennessee
-
Chattanooga, Tennessee, Stany Zjednoczone, 37404
- Memorial Hospital
-
Hixson, Tennessee, Stany Zjednoczone, 37343
- Pulmonary Medicine Center of Chattanooga-Hixson
-
Knoxville, Tennessee, Stany Zjednoczone, 37916
- East Tennessee Childrens Hospital
-
Memphis, Tennessee, Stany Zjednoczone, 38105
- Saint Jude Children's Research Hospital
-
Nashville, Tennessee, Stany Zjednoczone, 37232
- Vanderbilt University/Ingram Cancer Center
-
Nashville, Tennessee, Stany Zjednoczone, 37203
- The Children's Hospital at TriStar Centennial
-
Ooltewah, Tennessee, Stany Zjednoczone, 37363
- Memorial GYN Plus
-
-
Texas
-
Austin, Texas, Stany Zjednoczone, 78723
- Dell Children's Medical Center of Central Texas
-
Bryan, Texas, Stany Zjednoczone, 77802
- Saint Joseph Regional Cancer Center
-
Corpus Christi, Texas, Stany Zjednoczone, 78411
- Driscoll Children's Hospital
-
El Paso, Texas, Stany Zjednoczone, 79905
- El Paso Children's Hospital
-
Fort Worth, Texas, Stany Zjednoczone, 76104
- Cook Children's Medical Center
-
San Antonio, Texas, Stany Zjednoczone, 78207
- Children's Hospital of San Antonio
-
-
Utah
-
American Fork, Utah, Stany Zjednoczone, 84003
- American Fork Hospital / Huntsman Intermountain Cancer Center
-
Cedar City, Utah, Stany Zjednoczone, 84720
- Sandra L Maxwell Cancer Center
-
Logan, Utah, Stany Zjednoczone, 84321
- Logan Regional Hospital
-
Murray, Utah, Stany Zjednoczone, 84107
- Intermountain Medical Center
-
Ogden, Utah, Stany Zjednoczone, 84403
- McKay-Dee Hospital Center
-
Riverton, Utah, Stany Zjednoczone, 84065
- Riverton Hospital
-
Salt Lake City, Utah, Stany Zjednoczone, 84106
- Utah Cancer Specialists-Salt Lake City
-
Salt Lake City, Utah, Stany Zjednoczone, 84143
- LDS Hospital
-
St. George, Utah, Stany Zjednoczone, 84770
- Saint George Regional Medical Center
-
-
Virginia
-
Norfolk, Virginia, Stany Zjednoczone, 23507
- Children's Hospital of The King's Daughters
-
-
Washington
-
Aberdeen, Washington, Stany Zjednoczone, 98520
- Providence Regional Cancer System-Aberdeen
-
Auburn, Washington, Stany Zjednoczone, 98001
- MultiCare Auburn Medical Center
-
Bellevue, Washington, Stany Zjednoczone, 98004
- Overlake Medical Center
-
Bellingham, Washington, Stany Zjednoczone, 98225
- PeaceHealth Saint Joseph Medical Center
-
Burien, Washington, Stany Zjednoczone, 98166
- Saint Anne Hospital
-
Centralia, Washington, Stany Zjednoczone, 98531
- Providence Regional Cancer System-Centralia
-
Edmonds, Washington, Stany Zjednoczone, 98026
- Swedish Cancer Institute-Edmonds
-
Enumclaw, Washington, Stany Zjednoczone, 98022
- Saint Elizabeth Hospital
-
Everett, Washington, Stany Zjednoczone, 98201
- Providence Regional Cancer Partnership
-
Federal Way, Washington, Stany Zjednoczone, 98003
- Saint Francis Hospital
-
Gig Harbor, Washington, Stany Zjednoczone, 98335
- MultiCare Gig Harbor Medical Park
-
Issaquah, Washington, Stany Zjednoczone, 98029
- Swedish Cancer Institute-Issaquah
-
Kennewick, Washington, Stany Zjednoczone, 99336
- Kadlec Clinic Hematology and Oncology
-
Lacey, Washington, Stany Zjednoczone, 98503
- Providence Regional Cancer System-Lacey
-
Lakewood, Washington, Stany Zjednoczone, 98499
- Saint Clare Hospital
-
Longview, Washington, Stany Zjednoczone, 98632
- PeaceHealth Saint John Medical Center
-
Port Townsend, Washington, Stany Zjednoczone, 98368
- Jefferson Healthcare
-
Poulsbo, Washington, Stany Zjednoczone, 98370
- Harrison HealthPartners Hematology and Oncology-Poulsbo
-
Puyallup, Washington, Stany Zjednoczone, 98372
- MultiCare Good Samaritan Hospital
-
Renton, Washington, Stany Zjednoczone, 98055
- Valley Medical Center
-
Seattle, Washington, Stany Zjednoczone, 98105
- Seattle Children's Hospital
-
Seattle, Washington, Stany Zjednoczone, 98107
- Swedish Medical Center-Ballard Campus
-
Seattle, Washington, Stany Zjednoczone, 98122
- Swedish Medical Center-First Hill
-
Seattle, Washington, Stany Zjednoczone, 98112
- Kaiser Permanente Washington
-
Seattle, Washington, Stany Zjednoczone, 98104
- Pacific Gynecology Specialists
-
Seattle, Washington, Stany Zjednoczone, 98122-5711
- Swedish Medical Center-Cherry Hill
-
Sedro-Woolley, Washington, Stany Zjednoczone, 98284
- PeaceHealth United General Medical Center
-
Shelton, Washington, Stany Zjednoczone, 98584
- Providence Regional Cancer System-Shelton
-
Silverdale, Washington, Stany Zjednoczone, 98383
- Saint Joseph Medical Center Hematology and Oncology - Silverdale
-
Spokane, Washington, Stany Zjednoczone, 99204
- Providence Sacred Heart Medical Center and Children's Hospital
-
Spokane, Washington, Stany Zjednoczone, 99204
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
-
Spokane, Washington, Stany Zjednoczone, 99218
- MultiCare Deaconess Cancer and Blood Specialty Center - North
-
Spokane Valley, Washington, Stany Zjednoczone, 99216
- MultiCare Deaconess Cancer and Blood Specialty Center - Valley
-
Tacoma, Washington, Stany Zjednoczone, 98405
- Mary Bridge Children's Hospital and Health Center
-
Tacoma, Washington, Stany Zjednoczone, 98405
- Northwest Medical Specialties PLLC
-
Tacoma, Washington, Stany Zjednoczone, 98431
- Madigan Army Medical Center
-
Tacoma, Washington, Stany Zjednoczone, 98405
- MultiCare Tacoma General Hospital
-
Tacoma, Washington, Stany Zjednoczone, 98405
- Franciscan Research Center-Northwest Medical Plaza
-
Vancouver, Washington, Stany Zjednoczone, 98664
- PeaceHealth Southwest Medical Center
-
Walla Walla, Washington, Stany Zjednoczone, 99362
- Providence Saint Mary Regional Cancer Center
-
Yakima, Washington, Stany Zjednoczone, 98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
-
Yelm, Washington, Stany Zjednoczone, 98597
- Providence Regional Cancer System-Yelm
-
-
West Virginia
-
Bridgeport, West Virginia, Stany Zjednoczone, 26330
- United Hospital Center
-
Martinsburg, West Virginia, Stany Zjednoczone, 25401
- WVUH-Berkely Medical Center
-
Morgantown, West Virginia, Stany Zjednoczone, 26506
- West Virginia University Healthcare
-
Parkersburg, West Virginia, Stany Zjednoczone, 26101
- Camden Clark Medical Center
-
-
Wisconsin
-
Ashland, Wisconsin, Stany Zjednoczone, 54806
- Duluth Clinic Ashland
-
Ashland, Wisconsin, Stany Zjednoczone, 54806
- Northwest Wisconsin Cancer Center
-
Burlington, Wisconsin, Stany Zjednoczone, 53105
- Aurora Cancer Care-Southern Lakes VLCC
-
Chippewa Falls, Wisconsin, Stany Zjednoczone, 54729
- Marshfield Clinic-Chippewa Center
-
Eau Claire, Wisconsin, Stany Zjednoczone, 54701
- Marshfield Medical Center-EC Cancer Center
-
Fond du Lac, Wisconsin, Stany Zjednoczone, 54937
- Aurora Health Center-Fond du Lac
-
Germantown, Wisconsin, Stany Zjednoczone, 53022
- Aurora Health Care Germantown Health Center
-
Grafton, Wisconsin, Stany Zjednoczone, 53024
- Aurora Cancer Care-Grafton
-
Green Bay, Wisconsin, Stany Zjednoczone, 54311
- Aurora BayCare Medical Center
-
Kenosha, Wisconsin, Stany Zjednoczone, 53142
- Aurora Cancer Care-Kenosha South
-
La Crosse, Wisconsin, Stany Zjednoczone, 54601
- Gundersen Lutheran Medical Center
-
Ladysmith, Wisconsin, Stany Zjednoczone, 54848
- Marshfield Medical Center - Ladysmith
-
Madison, Wisconsin, Stany Zjednoczone, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
-
Marinette, Wisconsin, Stany Zjednoczone, 54143
- Aurora Bay Area Medical Group-Marinette
-
Marshfield, Wisconsin, Stany Zjednoczone, 54449
- Marshfield Medical Center-Marshfield
-
Milwaukee, Wisconsin, Stany Zjednoczone, 53226
- Medical College of Wisconsin
-
Milwaukee, Wisconsin, Stany Zjednoczone, 53209
- Aurora Cancer Care-Milwaukee
-
Milwaukee, Wisconsin, Stany Zjednoczone, 53215
- Aurora Saint Luke's Medical Center
-
Milwaukee, Wisconsin, Stany Zjednoczone, 53233
- Aurora Sinai Medical Center
-
Minocqua, Wisconsin, Stany Zjednoczone, 54548
- Marshfield Medical Center - Minocqua
-
Oshkosh, Wisconsin, Stany Zjednoczone, 54904
- Vince Lombardi Cancer Clinic - Oshkosh
-
Racine, Wisconsin, Stany Zjednoczone, 53406
- Aurora Cancer Care-Racine
-
Rice Lake, Wisconsin, Stany Zjednoczone, 54868
- Marshfield Medical Center-Rice Lake
-
Sheboygan, Wisconsin, Stany Zjednoczone, 53081
- Vince Lombardi Cancer Clinic-Sheboygan
-
Stevens Point, Wisconsin, Stany Zjednoczone, 54482
- Marshfield Medical Center-River Region at Stevens Point
-
Summit, Wisconsin, Stany Zjednoczone, 53066
- Aurora Medical Center in Summit
-
Two Rivers, Wisconsin, Stany Zjednoczone, 54241
- Vince Lombardi Cancer Clinic-Two Rivers
-
Wausau, Wisconsin, Stany Zjednoczone, 54401
- Marshfield Clinic-Wausau Center
-
Wauwatosa, Wisconsin, Stany Zjednoczone, 53226
- Aurora Cancer Care-Milwaukee West
-
West Allis, Wisconsin, Stany Zjednoczone, 53227
- Aurora West Allis Medical Center
-
Weston, Wisconsin, Stany Zjednoczone, 54476
- Marshfield Medical Center - Weston
-
Wisconsin Rapids, Wisconsin, Stany Zjednoczone, 54494
- Marshfield Clinic - Wisconsin Rapids Center
-
-
Wyoming
-
Cheyenne, Wyoming, Stany Zjednoczone, 82001
- Cheyenne Regional Medical Center-West
-
Cody, Wyoming, Stany Zjednoczone, 82414
- Billings Clinic-Cody
-
Sheridan, Wyoming, Stany Zjednoczone, 82801
- Welch Cancer Center
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
-
PHASE I (ARMS A, B, C, D, E, F, G, H, I, X, Y, Z)
-
Age >= 18 years
-
Patients must have pathologically confirmed relapsed or refractory classical Hodgkin lymphoma (cHL); a biopsy at any relapse is acceptable; other histologies including lymphocyte predominant (LP) HL are not permitted
-
Patients must have relapsed after first line chemotherapy; may have relapsed after autologous or allogeneic stem cell transplant, or have primary refractory disease; no upper limit for number of prior therapies; if status post allogeneic stem cell transplant, no active graft versus host disease
-
Patients may have received prior brentuximab vedotin, but must not have received brentuximab vedotin within 6 months prior to registration, and must not have relapsed within 6 months of receiving previous brentuximab vedotin; patients may not have received prior nivolumab or PD1/PDL1 axis agents; patients in the nivolumab/brentuximab cohorts ONLY (D, E, F, Y) may have received prior ipilimumab
-
Patients may have received other prior activating immunotherapies (i.e. checkpoint inhibitors), but must not have received them within 6 months prior to registration, and there must be no serious unresolved complication of therapy at the time of registration; for the purposes of this study monoclonal antibodies and antibody drug conjugates are not considered to be activating immunotherapies and there are no additional time restrictions on prior exposure to these agents (except prior brentuximab vedotin)
-
Eastern Cooperative Oncology Group (ECOG)-American College of Radiology Imaging Network (ACRIN) performance status between 0-2
-
Patients must have measurable disease; baseline measurements and evaluations must be obtained within 4 weeks of registration to the study; abnormal PET scans will not constitute evaluable disease unless verified by a diagnostic quality CT scan; patients must use the same imaging modality (CT or PET/CT) throughout the study
-
Patient must not be pregnant or breast-feeding due to risk of fetal harm by the chemotherapeutic agents prescribed in this protocol; all patients of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a patient of childbearing potential is anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
-
Patient of childbearing potential and/or sexually active patients must either abstain from sexual intercourse for the duration of their participation in the study or agree to use both single barrier contraception and birth control pills or implants for at least one week prior to the start of the study drug and continuing for 5 months after the last dose of study drug (for patients of childbearing potential) and for 7 months after the last dose of study drug (for patients who are sexually active with anyone of childbearing potential); should a patient become pregnant or suspect pregnancy while the patient or their partner is participating in this study, the patient (or the participating partner) should inform the treating physician immediately
-
Patients must have no evidence of dyspnea at rest and a pulse oximetry > 92% while breathing room air
-
Patients must have forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) > 60% by pulmonary function test (PFT), unless due to large mediastinal mass from HL; carbon monoxide diffusion capacity (DLCO), FEV1, and FVC all > 50% predicted value; all pulmonary function tests must be obtained within one month prior to registration
-
Absolute neutrophil count (ANC) >= 1500/mcL (1.5 x 10^9/L) (obtained within 2 weeks prior to registration)
-
Platelets >= 75,000/mcL (75 x 10^9/L) (obtained within 2 weeks prior to registration)
-
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN) (obtained within 2 weeks prior to registration)
-
Bilirubin =< 2 x upper limit of normal (ULN) (unless documented Gilbert's syndrome, for which bilirubin =< 3 x upper limit of normal [ULN] is permitted) (obtained within 2 weeks prior to registration)
-
Calculated creatinine clearance by Cockcroft-Gault formula >= 30 ml/min (obtained within 2 weeks prior to registration)
-
No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma or any surgically- or radiation-cured malignancy continuously disease free for >= 5 years so as not to interfere with interpretation of radiographic response
-
Patient must have no current or prior history of central nervous system (CNS) involvement
-
All prior therapy must have been completed at least 21 days prior to enrollment; no concomitant anti lymphoma therapy, including systemic corticosteroids for the purpose of treatment of lymphoma are allowed; topical steroids are allowed
-
No history of Steven's Johnson's syndrome, toxic epidermal necrolysis (TEN)s syndrome, or motor neuropathy
-
Human immunodeficiency virus (HIV) positive patients are allowed on this study if they have a CD4 count > 400, and are on a stable antiviral regimen; patients with poorly controlled HIV or other chronic active viral infections will be excluded
-
Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids; a history of occasional (but not continuous) use of steroid inhalers is allowed
- Replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of these classes of medication for at least 2 weeks prior to initiation of study treatment are eligible if, in the judgment of the treating physician investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study
- Exclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjogren's syndrome, autoimmune vasculitis [e.g., Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia Gravis); other CNS autoimmune disease (e.g., Multiple sclerosis); patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligible
-
Patients must not have grade 2 or greater peripheral sensory neuropathy
-
Patients must not have New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
-
Patients must not have previously existing hypersensitivity to brentuximab vedotin or ipilimumab
-
Patients must not have a serious medical or psychiatric illness likely to interfere with study participation
-
Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
-
Routine vaccinations, including seasonal influenza, should be given at least 2 weeks prior to study treatment; vaccines are not prohibited on study, but must be given at least 6 weeks after cycle 1 and not within 7 days of treatment
-
Patients registering to Arms D, E, F, G, H, I, X, Y must not currently be smoking tobacco or other substances and must not have smoked within the past 6 months
-
RANDOMIZED PHASE II (ARMS K AND L): Age >= 12 years
- Pediatric patients will include any patients < 18 years of age
-
RANDOMIZED PHASE II (ARMS K AND L): Patients must have pathologically confirmed relapsed or refractory classical Hodgkin lymphoma (cHL); a biopsy at any relapse is acceptable; other histologies including lymphocyte predominant (LP) HL are not permitted
-
RANDOMIZED PHASE II (ARMS K AND L): Patients must have relapsed after first line chemotherapy; may have relapsed after autologous stem cell transplant, or have primary refractory disease; no upper limit for number of prior therapies; patient must not have received a prior allogeneic stem cell transplant (out of risk of reactivation of pulmonary graft versus host disease [GVHD])
-
RANDOMIZED PHASE II (ARMS K AND L): Patients may have received prior brentuximab vedotin, but must not have received brentuximab vedotin within 6 months prior to registration, and must not have relapsed within 6 months of receiving previous brentuximab vedotin; patients may not have received prior nivolumab or PD1/PDL1 axis agents; patients may not have received prior ipilimumab
-
RANDOMIZED PHASE II (ARMS K AND L): Patients may not have received other prior activating immunotherapies (i.e. checkpoint inhibitor therapies); for the purposes of this study monoclonal antibodies and antibody drug conjugates are not considered to be activating immunotherapies and there are no additional time restrictions on prior exposure to these agents (except prior brentuximab vedotin)
-
RANDOMIZED PHASE II (ARMS K AND L): Adult patient (>= 18 years of age) ECOG-ACRIN performance status between 0-2
- Pediatric patients (16-17 years of age) must have a Karnofsky performance level >= 50%
- Pediatric patients (12-15 years of age) must have a Lansky performance level >= 50
-
RANDOMIZED PHASE II (ARMS K AND L): Patients must have measurable disease; baseline measurements and evaluations must be obtained within 4 weeks of registration to the study; abnormal PET scans will not constitute evaluable disease unless verified by a diagnostic quality CT scan; patients must use the same imaging modality (CT or PET/CT) throughout the study
-
RANDOMIZED PHASE II (ARMS K AND L): Patient must not be pregnant or breast-feeding due to risk of fetal harm by the chemotherapeutic agents prescribed in this protocol; all patients of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
-
RANDOMIZED PHASE II (ARMS K AND L): Patient of childbearing potential and/or sexually active patient must either abstain from sexual intercourse for the duration of their participation in the study or agree to use both double barrier contraception and birth control pills or implants for at least one week prior to the start of the study drug and continuing for 5 months after the last dose of study drug (for patients of childbearing potential) and for 7 months after the last dose of study drug (for patients who are sexually active with anyone of childbearing potential); should a patient become pregnant or suspect pregnancy while the patient or their partner is participating in this study, the patient (or the participating partner) should inform the treating physician immediately
-
RANDOMIZED PHASE II (ARMS K AND L): Patients with impaired decision-making capacity are eligible with legally authorized representative
-
RANDOMIZED PHASE II (ARMS K AND L): Patients must have no evidence of dyspnea at rest and a pulse oximetry > 92% while breathing room air
-
RANDOMIZED PHASE II (ARMS K AND L): Patients must have FEV1/FVC > 60% by pulmonary function test (PFT), unless due to large mediastinal mass from HL; carbon monoxide diffusion capacity (DLCO), FEV1, and FVC all > 50% predicted value; all pulmonary function tests must be obtained within one month prior to registration
-
RANDOMIZED PHASE II (ARMS K AND L): ANC >= 1500/mcL (1.5 x 0^9/L) (obtained within 2 weeks prior to registration)
-
RANDOMIZED PHASE II (ARMS K AND L): Platelets >= 75,000/mcL (75 x 10^9/L) (obtained within 2 weeks prior to registration)
-
RANDOMIZED PHASE II (ARMS K AND L): AST/ALT =< 2.5 x upper limit of normal (ULN) for age (obtained within 2 weeks prior to registration)
-
RANDOMIZED PHASE II (ARMS K AND L): Bilirubin =< 2 x upper limit of normal (ULN) (unless documented Gilbert's syndrome, for which bilirubin =< 3 x upper limit of normal [ULN] is permitted) (obtained within 2 weeks prior to registration)
-
RANDOMIZED PHASE II (ARMS K AND L): Adult patients (>= 18 years old) must have a calculated creatinine clearance by Cockcroft-Gault formula >= 30 ml/min (obtained within 2 weeks prior to registration)
-
RANDOMIZED PHASE II (ARMS K AND L): Pediatric patients (< 18 years old) must have a creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or serum creatinine based on age/sex as follows:
-
Age: maximum serum creatinine (mg/dL)
- < 13 years: male (1.2), female (1.2)
- 13 to < 16 years: male (1.5), female (1.4)
- >= 16 years: male (1.7), female (1.4)
-
-
RANDOMIZED PHASE II (ARMS K AND L): No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma or any surgically- or radiation-cured malignancy continuously disease free for >= 5 years so as not to interfere with interpretation of radiographic response
-
RANDOMIZED PHASE II (ARMS K AND L): Patient must have no current or prior history of CNS involvement
-
RANDOMIZED PHASE II (ARMS K AND L): All prior therapy must have been completed at least 21 days prior to enrollment (6 weeks for nitrosoureas or mitomycin C); no concomitant anti lymphoma therapy, including systemic corticosteroids for the purpose of treatment of lymphoma are allowed; topical steroids are allowed
-
RANDOMIZED PHASE II (ARMS K AND L): No history of Steven's Johnson's syndrome, TENs syndrome, or motor neuropathy
-
RANDOMIZED PHASE II (ARMS K AND L): HIV positive patients are eligible provided they meet the other protocol criteria including the following:
- Long term survival expected were it not for the cHL
- HIV viral loads undetectable by standard clinical HIV testing
- Willing to adhere to effective combination antiretroviral therapy
-
RANDOMIZED PHASE II (ARMS K AND L): Patients must not have autoimmune disorders, prior solid organ transplant, or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids; a history of occasional (but not continuous) use of steroid inhalers is allowed; replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of steroid medication for at least 2 weeks prior to initiation of therapy are eligible if, in the judgment of the treating physician investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study; exclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjogren's syndrome, autoimmune vasculitis [e.g., Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia Gravis); other CNS autoimmune disease (e.g., Multiple sclerosis); patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligible
-
RANDOMIZED PHASE II (ARMS K AND L): Patients must not have grade 2 or greater peripheral sensory neuropathy
-
RANDOMIZED PHASE II (ARMS K AND L): Patients must not have NYHA class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
-
RANDOMIZED PHASE II (ARMS K AND L): Patients must not have previously existing hypersensitivity to brentuximab vedotin or ipilimumab
-
RANDOMIZED PHASE II (ARMS K AND L): Patients must not have a serious medical or psychiatric illness likely to interfere with study participation
-
RANDOMIZED PHASE II (ARMS K AND L): Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
-
RANDOMIZED PHASE II (ARMS K AND L): Routine vaccinations, including seasonal influenza, should be given at least 2 weeks prior to study treatment; vaccines are not prohibited on study, but must be given at least 6 weeks after cycle 1 and not within 7 days of treatment
-
RANDOMIZED PHASE II (ARMS K AND L): Patients must not currently be smoking tobacco or other agents; vaping is not allowed
-
RANDOMIZED PHASE II (ARMS K AND L): Patients must not have a history of or evidence of cardiovascular risks including any of the following:
- QT interval corrected for heart rate using the Bazett's formula QTcB >= 480 msec at baseline
- History of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within the past 24 weeks prior to registration
- History prior to registration or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system
- Left ventricular ejection fraction (LVEF) =< lower limit of normal on cardiac echocardiogram (echo) or multigated acquisition scan (MUGA)
- Intra-cardiac defibrillator
- History of abnormal cardiac valve morphology (>= grade 2) documented by ECHO; (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study); subjects with moderate valvular thickening should not be entered on study
- History or evidence of current clinically significant uncontrolled cardiac arrhythmias; clarification: subjects with atrial fibrillation controlled for > 30 days prior to dosing are eligible
- Treatment refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mm Hg which cannot be controlled by anti-hypertensive therapy
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Phase I Arm I (brentuximab vedotin, ipilimumab)
Patients receive brentuximab vedotin IV over 30 minutes on day 1 of cycles 1-16 and ipilimumab IV over 90 minutes on day 1 of cycles 1-4, 8, 12, and 16. Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET scan throughout the trial. Patients undergo blood sample collection and may undergo tumor biopsy on study. |
Given IV
Inne nazwy:
Undergo CT
Inne nazwy:
Undergo biopsy
Inne nazwy:
Undergo collection of blood
Inne nazwy:
Given IV
Inne nazwy:
Undergo PET
Inne nazwy:
|
|
Eksperymentalny: Phase I Arm II (brentuximab vedotin, nivolumab)
Patients receive brentuximab vedotin IV over 90 minutes on day 1 of cycles 1-16 and nivolumab IV over 30 minutes on day 1 of cycles 1-46. Treatment repeats every 21 days for up to 16 cycles and every 14 days beginning cycle 17 for up to 46 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET scan throughout the trial. Patients undergo blood sample collection and may undergo tumor biopsy on study. |
Undergo CT
Inne nazwy:
Undergo biopsy
Inne nazwy:
Undergo collection of blood
Inne nazwy:
Given IV
Inne nazwy:
Undergo PET
Inne nazwy:
Given IV
Inne nazwy:
|
|
Eksperymentalny: Phase I Arm III (brentuximab vedotin, nivolumab, ipilimumab)
Patients receive brentuximab vedotin IV over 90 minutes on day 1 of cycles 1-16, nivolumab IV over 30 minutes on day 1 of cycles 1-46, and ipilimumab IV over 30 minutes on day 1 every 12 weeks for up to 9 doses. Treatment repeats every 21 days for up to 16 cycles and every 14 days beginning cycle 17 for up to 46 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET scan throughout the trial. Patients undergo blood sample collection and may undergo tumor biopsy on study. |
Given IV
Inne nazwy:
Undergo CT
Inne nazwy:
Undergo biopsy
Inne nazwy:
Undergo collection of blood
Inne nazwy:
Given IV
Inne nazwy:
Undergo PET
Inne nazwy:
Given IV
Inne nazwy:
|
|
Eksperymentalny: Phase II Arm I (brentuximab vedotin, nivolumab)
Patients receive brentuximab vedotin IV over 90 minutes on day 1 of cycles 1-16 and nivolumab IV over 30 minutes on day 1 of cycles 1-34. Treatment repeats every 21 days for up to 34 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET scan throughout the trial. Patients undergo blood sample collection and may undergo tumor biopsy on study. |
Undergo CT
Inne nazwy:
Undergo biopsy
Inne nazwy:
Undergo collection of blood
Inne nazwy:
Given IV
Inne nazwy:
Undergo PET
Inne nazwy:
Given IV
Inne nazwy:
|
|
Eksperymentalny: Phase II Arm II (brentuximab vedotin, nivolumab, ipilimumab)
Patients receive brentuximab vedotin IV over 90 minutes on day 1 of cycles 1-16, nivolumab IV over 30 minutes on day 1 of cycles 1-34, and ipilimumab IV over 30 minutes on day 1 every 12 weeks for up to 9 doses. Treatment repeats every 21 days for up to 34 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET scan throughout the trial. Patients undergo blood sample collection and may undergo tumor biopsy on study. |
Given IV
Inne nazwy:
Undergo CT
Inne nazwy:
Undergo biopsy
Inne nazwy:
Undergo collection of blood
Inne nazwy:
Given IV
Inne nazwy:
Undergo PET
Inne nazwy:
Given IV
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Maximum tolerated dose (MTD) of each combination (Phase I)
Ramy czasowe: 21 days
|
MTD defined as the highest dose level at which less than 33% of 6 patients experience a dose limiting toxicity, will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Upon completion of the trial, frequency of subjects experiencing toxicities will be tabulated. Toxicities will be assessed and graded according to CTCAE version 4.0 terminology. Exact 95% confidence intervals (CI) around the toxicity proportions will be calculated. |
21 days
|
|
CR rate (Phase II)
Ramy czasowe: Up to 10 years
|
The analysis of CR between two arms will be performed using exact Cochran-Mantel-Haenszel (CMH) test stratifying on prior brentuximab vedotin (BV) (yes versus [vs.] no) and age (< 18 vs. >= 18). Multivariable logistic regression modeling will be used to adjust for the effect of any covariates that are associated with these categorical outcomes. |
Up to 10 years
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Complete response (CR) rate (Phase I)
Ramy czasowe: Up to 3 years
|
Assessed using the Revised Response Criteria for Malignant Lymphoma and reported along with the 95% CI. |
Up to 3 years
|
|
Partial response (PR) rate (Phase I)
Ramy czasowe: Up to 3 years
|
Assessed using the Revised Response Criteria for Malignant Lymphoma and reported along with the 95% CI. |
Up to 3 years
|
|
Overall response rate (ORR) rate (Phase I)
Ramy czasowe: Up to 3 years
|
Assessed using the Revised Response Criteria for Malignant Lymphoma and reported along with the 95% CI. |
Up to 3 years
|
|
Duration of response (DOR) (Phase I)
Ramy czasowe: From the documented beginning of response up to 3 years
|
DOR will be estimated using Kaplan-Meier methodology. Greenwood's formula will be used to calculate 95% CI for the Kaplan-Meier estimates. Descriptive statistics will be used to evaluate the DOR achieved with the protocol therapy and with the most recent prior systemic therapy. |
From the documented beginning of response up to 3 years
|
|
Overall survival (OS) (Phase I)
Ramy czasowe: From the date of study entry up to 3 years
|
OS will be estimated using Kaplan-Meier methodology. Greenwood's formula will be used to calculate 95% CI for the Kaplan-Meier estimates. |
From the date of study entry up to 3 years
|
|
Progression-free survival (PFS) (Phase I)
Ramy czasowe: From entry onto study up to 3 years
|
PFS will be estimated using Kaplan-Meier methodology. Greenwood's formula will be used to calculate 95% CI for the Kaplan-Meier estimates. |
From entry onto study up to 3 years
|
|
ORR (Phase II)
Ramy czasowe: Up to 10 years
|
Assessed using Revised Response (Cheson) and Deauville criteria. The analysis of ORR between two arms will be performed using the CMH test stratifying on prior BV (yes vs. no) and age (< 18 vs. >= 18). Multivariable logistic regression modeling will be used to adjust for the effect of any covariates that are associated with these categorical outcomes. |
Up to 10 years
|
|
PFS (or modified PFS) (Phase II)
Ramy czasowe: From randomization up to 10 years
|
PFS will be estimated using Kaplan-Meier methodology and compared between arms using stratified log-rank test. Greenwood's formula will be used to calculate 95% confidence intervals for the Kaplan-Meier estimates. Cox proportional regression model will be used to estimate hazard ratios (95% CI) and assess the relationship between other prognostic factors with time-to-event outcome. Point estimates of all endpoints will be accompanied by the corresponding 95% confidence intervals. |
From randomization up to 10 years
|
|
OS (Phase II)
Ramy czasowe: From randomization up to 10 years
|
OS will be estimated using Kaplan-Meier methodology and compared between arms using stratified log-rank test. Greenwood's formula will be used to calculate 95% confidence intervals for the Kaplan-Meier estimates. Cox proportional regression model will be used to estimate hazard ratios (95% CI) and assess the relationship between other prognostic factors with time-to-event outcome. Point estimates of all endpoints will be accompanied by the corresponding 95% confidence intervals. |
From randomization up to 10 years
|
|
DOR (Phase II)
Ramy czasowe: From the documented beginning of response up to 10 years
|
DOR, will be estimated using Kaplan-Meier methodology and compared between arms using stratified log-rank test. Greenwood's formula will be used to calculate 95% confidence intervals for the Kaplan-Meier estimates. Cox proportional regression model will be used to estimate hazard ratios (95% CI) and assess the relationship between other prognostic factors with time-to-event outcome. Point estimates of all endpoints will be accompanied by the corresponding 90% confidence intervals. The DOR achieved with the most recent prior systemic therapy will be collected on the case report forms, and descriptive statistics will be used to evaluate the DOR achieved with the protocol therapy and with the most recent prior systemic therapy. |
From the documented beginning of response up to 10 years
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Wpływ kombinacji na odporność ogólnoustrojową (faza I i II)
Ramy czasowe: Wartość wyjściowa do 6 tygodni po zakończeniu badanego leczenia
|
Wartość wyjściowa do 6 tygodni po zakończeniu badanego leczenia
|
|
|
Change in the percentage of activated T cells and natural killer cells (Phase I and II)
Ramy czasowe: Baseline (Time 1) to 9 weeks (Time 3, time of first re-staging)
|
These quantities of interest will be calculated for each patient and the Wilcoxon signed-rank test will be used to test for significant difference between the time points. Using Wilcoxon rank sum test (two-sided type I error of 0.1), differences between those who progress or die within one year versus (vs.) those who are event-free at one year will be evaluated. |
Baseline (Time 1) to 9 weeks (Time 3, time of first re-staging)
|
|
Change in the percentages of activated T cells and natural killer cells (Phase I and II)
Ramy czasowe: Day 1 of cycle 2 (Time 2) or 9 weeks (Time 3) to up to 6 weeks after completion of study treatment (Time 4, end of study)
|
These quantities of interest will be calculated for each patient and the Wilcoxon signed-rank test will be used to test for significant difference between the time points. Using the Wilcoxon rank sum test (two-sided type I error of 0.1), differences between those who progress or die within one year vs. those who are event-free at one year will be evaluated. |
Day 1 of cycle 2 (Time 2) or 9 weeks (Time 3) to up to 6 weeks after completion of study treatment (Time 4, end of study)
|
|
Pre- and post-treatment levels of cytokines and T cell specific biomarkers (Phase I and II)
Ramy czasowe: Baseline to up to 6 weeks after completion of study treatment
|
Pre- and post-treatment levels of these markers will be compared using the Wilcoxon signed-rank test with two-sided type I error of 0.1. Marker levels between patients who fail at 1-year vs. patients who are event-free at 1-year will be evaluated. Given limited data, the analyses of PD-1, co-expression of Tim-3 with PD-1, ICOS, sCD30, galectin-1 and the peripheral blood absolute lymphocyte to monocyte ratio will be mainly exploratory and will be summarized descriptively at the time-points described above. The association with PFS will be explored. |
Baseline to up to 6 weeks after completion of study treatment
|
|
Differentially expressed genes between two groups (patients who fail at 1-year vs. patients who are event-free at 1-year or responders vs. non-responders) (Phase I and II)
Ramy czasowe: 1 year
|
Assessed using gene expression profiling (GEP). Differentially expressed genes will be identified using a rank-based method developed by Dr. Hong (RankProd, R package, Bioconductor Project) with multiple comparison adjustment using a false discovery rate approach. A two-way unsupervised hierarchical clustering analysis will be applied to both the genes and the samples to illustrate whether GEP can separate two groups or is associated with other clinical factors. The genes ranked as most significant will be assessed by gene ontology and pathway analysis for their potential functions in lymphoma biology and treatment failure. |
1 year
|
|
Microbiome analysis (Phase I and II)
Ramy czasowe: Completion of study treatment
|
Will compare the gut microbiome between Hodgkin lymphoma (HL) patients and healthy controls with respect to global diversity, taxonomic abundance, and bacterial functional pathways. The relative abundance of each taxon (phyla to genera) and functional pathways among different groups will be statistically compared in univariate analysis using t-test (or Wilcoxon test) and in multivariate analysis using logistic regression. Global diversity tests and multivariate analysis for taxonomic abundance and functional pathways will be adjusted for potential confounders (age, sex, race, and body mass index) in the comparisons of HL patients and controls, and further adjusted for stage and grade when examining the clinical response among HL patients. |
Completion of study treatment
|
|
Absolute maximum standard uptake value (SUVmax) (Phase II)
Ramy czasowe: Up to cycle 10
|
Image data will be evaluated using Lugano response criteria with various D 5PS cut-offs in the entire cohort and in different therapy cohorts to determine if the existing set of criteria is sufficient to segregate the group into various response categories. Will correlate PFS, event free survival (EFS), OS 5PS in two reading settings (1-3 [negative] vs 4-5 [positive] and D 5PS 1-4 [negative] vs 5 [positive]) (Kaplan-Meier [KM] curve and log-rank testing). |
Up to cycle 10
|
|
Metabolic whole body tumor volume (MTV) and tumor lesion glycolysis (TLG)
Ramy czasowe: Up to cycle 10
|
Image data will be evaluated using Lugano response criteria with various D 5PS cut-offs in the entire cohort and in different therapy cohorts to determine if the existing set of criteria is sufficient to segregate the group into various response categories. Will correlate PFS, EFS, OS 5PS in two reading settings (1-3 [negative] vs 4-5 [positive] and D 5PS 1-4 [negative] vs 5 [positive]) (KM curve and log-rank testing). |
Up to cycle 10
|
|
Percent change in SUVmax, MTV and TLG between baseline and during therapy
Ramy czasowe: Baseline up to cycle 10
|
Image data will be evaluated using Lugano response criteria with various D 5PS cut-offs in the entire cohort and in different therapy cohorts to determine if the existing set of criteria is sufficient to segregate the group into various response categories. Will correlate PFS, EFS, OS 5PS in two reading settings (1-3 [negative] vs 4-5 [positive] and D 5PS 1-4 [negative] vs 5 [positive]) (KM curve and log-rank testing). |
Baseline up to cycle 10
|
|
Percent change in size (sum of perpendicular diameters [SPD]) on computed tomography (CT)
Ramy czasowe: Baseline up to cycle 10
|
Image data will be evaluated using Lugano response criteria with various D 5PS cut-offs in the entire cohort and in different therapy cohorts to determine if the existing set of criteria is sufficient to segregate the group into various response categories. Will correlate PFS, EFS, OS 5PS in two reading settings (1-3 [negative] vs 4-5 [positive] and D 5PS 1-4 [negative] vs 5 [positive]) (KM curve and log-rank testing). |
Baseline up to cycle 10
|
|
Absolute CT tumor volumes
Ramy czasowe: Up to cycle 10
|
Image data will be evaluated using Lugano response criteria with various D 5PS cut-offs in the entire cohort and in different therapy cohorts to determine if the existing set of criteria is sufficient to segregate the group into various response categories. Will correlate PFS, EFS, OS 5PS in two reading settings (1-3 [negative] vs 4-5 [positive] and D 5PS 1-4 [negative] vs 5 [positive]) (KM curve and log-rank testing). |
Up to cycle 10
|
|
Percent change in CT size (SPD) and in CT tumor volume between baseline and during therapy
Ramy czasowe: Baseline up to cycle 10
|
Image data will be evaluated using Lugano response criteria with various D 5PS cut-offs in the entire cohort and in different therapy cohorts to determine if the existing set of criteria is sufficient to segregate the group into various response categories. Will correlate PFS, EFS, OS 5PS in two reading settings (1-3 [negative] vs 4-5 [positive] and D 5PS 1-4 [negative] vs 5 [positive]) (KM curve and log-rank testing). |
Baseline up to cycle 10
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Catherine S Diefenbach, ECOG-ACRIN Cancer Research Group
Publikacje i pomocne linki
Publikacje ogólne
- Diefenbach CS, Hong F, Ambinder RF, Cohen JB, Robertson MJ, David KA, Advani RH, Fenske TS, Barta SK, Palmisiano ND, Svoboda J, Morgan DS, Karmali R, Sharon E, Streicher H, Kahl BS, Ansell SM. Ipilimumab, nivolumab, and brentuximab vedotin combination therapies in patients with relapsed or refractory Hodgkin lymphoma: phase 1 results of an open-label, multicentre, phase 1/2 trial. Lancet Haematol. 2020 Sep;7(9):e660-e670. doi: 10.1016/S2352-3026(20)30221-0.
- Castellino SM, Giulino-Roth L, Harker-Murray P, Kahn JM, Forlenza C, Cho S, Hoppe B, Parsons SK, Kelly KM; COG Hodgkin Lymphoma Committee. Children's Oncology Group's 2023 blueprint for research: Hodgkin lymphoma. Pediatr Blood Cancer. 2023 Sep;70 Suppl 6(Suppl 6):e30580. doi: 10.1002/pbc.30580. Epub 2023 Jul 28.
- Gonzalez-Kozlova E, Huang HH, Jagede OA, Tuballes K, Del Valle DM, Kelly G, Patel M, Xie H, Harris J, Argueta K, Nie K, Barcessat V, Moravec R, Altreuter J, Duose DY, Kahl BS, Ansell SM, Yu J, Cerami E, Lindsay JR, Wistuba II, Kim-Schulze S, Diefenbach CS, Gnjatic S. Tumor-Immune Signatures of Treatment Resistance to Brentuximab Vedotin with Ipilimumab and/or Nivolumab in Hodgkin Lymphoma. Cancer Res Commun. 2024 Jul 1;4(7):1726-1737. doi: 10.1158/2767-9764.CRC-24-0252.
- Mu-Mosley H, von Itzstein MS, Fattah F, Liu J, Zhu C, Xie Y, Wakeland EK, Park JY, Kahl BS, Diefenbach CS, Gerber DE. Distinct autoantibody profiles across checkpoint inhibitor types and toxicities. Oncoimmunology. 2024 May 9;13(1):2351255. doi: 10.1080/2162402X.2024.2351255. eCollection 2024.
- Diefenbach CS, Jegede O, Wang V, Ansell SM, Kostakoglu L, Steidl C, Natkunam Y, Scott DW, Ambinder RF, David KA, Advani RH, Bartlett NL, Robertson MJ, Thomas SP, Cohen J, Ibrahimi S, Goyal G, Mehta-Shah N, Amengual JE, Forlenza CJ, Cole PD, Duan F, Kelly K, Kahl BS. A randomized phase 2 study of ipilimumab, nivolumab, and brentuximab vedotin in patients with relapsed Hodgkin lymphoma. Blood. 2026 Apr 30;147(18):2041-2052. doi: 10.1182/blood.2025029546.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Szacowany)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Peptydy
- Aminokwasy, peptydy i białka
- Oligopeptydy
- Białka
- Techniki śledcze
- Techniki laboratoryjne kliniczne
- Techniki i procedury diagnostyczne
- Diagnoza
- Procedury chirurgiczne, operacyjny
- Techniki cytologiczne
- Cytodiagnoza
- Czynniki biologiczne
- Przeciwciała, monoklonalne, humanizowane
- Przeciwciała, monoklonalne
- Przeciwciała
- Immunoglobuliny
- Immunoproteiny
- Białka krwi
- Globuliny w surowicy
- Globuliny
- Techniki diagnostyczne, chirurgiczne
- Techniki chemii, analityczne
- Analiza widma
- Receptory, powierzchnia komórkowa
- Białka błony
- Antygeny
- Antygeny, powierzchnia
- Biomarkery
- Receptory, immunologiczne
- Antygeny, różnicowanie, limfocyt t
- Antygeny, różnicowanie
- Białka immunologiczne
- Kostymulujące i hamujące receptory komórek T
- Niwolumab
- Ipilimumab
- Brentuksymab vedotin
- Biopsja
- Prowadzenie okazów
- Spektroskopia rezonansu magnetycznego
- Antygen CTLA-4
Inne numery identyfikacyjne badania
- NCI-2013-01275
- U10CA180820 (Grant/umowa NIH USA)
- U24CA196172 (Grant/umowa NIH USA)
- NCI-2013-01275 (Identyfikator rejestru: CTRP (Clinical Trial Reporting Program))
- E4412 (Inny identyfikator: CTEP)
- S14-00011
- E4412
- E4412 (Inny identyfikator: ECOG-ACRIN Cancer Research Group)
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