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Evaluering av tillegget av immunterapimedisinen Atezolizumab til standard kjemoterapibehandling for avanserte eller metastatiske nevroendokrine karsinomer som har sin opprinnelse utenfor lungen

5. november 2026 oppdatert av: National Cancer Institute (NCI)

Randomized Phase II/III Trial of First Line Platinum/Etoposide With or Without Atezolizumab (NSC#783608) in Patients With Advanced or Metastatic Poorly Differentiated Extrapulmonary Neuroendocrine Carcinomas (NEC)

This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). The other aim of this trial is to compare using atezolizumab just at the beginning of treatment versus continuing it beyond the initial treatment. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin and carboplatin are in a class of medications known as platinum-containing compounds that work by killing, stopping or slowing the growth of cancer cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. Giving atezolizumab in combination with a platinum drug (cisplatin or carboplatin) and etoposide may work better in treating patients with poorly differentiated extrapulmonary neuroendocrine cancer compared to standard therapy with a platinum drug (cisplatin or carboplatin) and etoposide alone.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

PRIMARY OBJECTIVES:

I. Compare the combination of induction platinum/etoposide and atezolizumab followed by maintenance atezolizumab (Arm 1) versus induction platinum/etoposide alone (Arm 3).

II. Compare the combination of induction platinum/etoposide and atezolizumab followed by observation (Arm 2) versus induction platinum/etoposide alone (Arm 3).

III. Compare the combination of induction platinum/etoposide and atezolizumab followed by maintenance atezolizumab (Arm 1) versus the combination of induction platinum/etoposide and atezolizumab followed by observation (Arm 2).

SECONDARY OBJECTIVES:

I. To compare overall survival (OS), measured from start of observation/maintenance, across arms.

II. To compare progression free survival (PFS) (measured from randomization and measured from start of observation/maintenance) across arms.

III. To compare objective response rate (ORR = confirmed and unconfirmed partial response [PR] + confirmed and unconfirmed complete response [CR]) across arms among patients with measurable disease at randomization.

IV. To compare clinical benefit rate (CBR = confirmed and unconfirmed PR + confirmed and unconfirmed CR + stable disease [SD]) across arms among patients with measurable disease at randomization.

V. To compare duration of response (DOR) across arms. VI. To evaluate the safety and tolerability of each arm.

ADDITIONAL OBJECTIVE:

I. To bank tumor and blood samples for future biomarker correlative studies.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: During induction phase, patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1 of each cycle, carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle, and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. During maintenance phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity.

ARM II (CLOSED TO ACCRUAL 7/9/26): During induction phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle, and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo observation for 1 year.

ARM III: During induction phase, patients receive carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo observation for 1 year.

Patients in all arms also undergo computed tomography (CT) scan and/or magnetic resonance imaging (MRI) throughout the trial and blood sample collection on study.

After completion of study treatment, patients are followed up for 5 years.

Studietype

Intervensjonell

Registrering (Antatt)

189

Fase

  • Fase 2
  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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      • Cameron Park, California, Forente stater, 95682
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      • Carmichael, California, Forente stater, 95608
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      • Fontana, California, Forente stater, 92335
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        • Kaiser Permanente-Fontana
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      • Fremont, California, Forente stater, 94538
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      • Rocklin, California, Forente stater, 95765
      • Roseville, California, Forente stater, 95661
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        • Sutter Cancer Centers Radiation Oncology Services-Roseville
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      • Sacramento, California, Forente stater, 95816
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      • Sunnyvale, California, Forente stater, 94086
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        • Palo Alto Medical Foundation-Sunnyvale
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      • Vallejo, California, Forente stater, 94589
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        • Sutter Solano Medical Center/Cancer Center
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      • Woodland, California, Forente stater, 95695
      • Woodland Hills, California, Forente stater, 91367
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    • Colorado
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      • Littleton, Colorado, Forente stater, 80122
      • Parker, Colorado, Forente stater, 80138
    • Connecticut
      • Derby, Connecticut, Forente stater, 06418
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        • Smilow Cancer Hospital-Derby Care Center
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      • Fairfield, Connecticut, Forente stater, 06824
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      • Glastonbury, Connecticut, Forente stater, 06033
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      • Hartford, Connecticut, Forente stater, 06105
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        • Yale University
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        • Smilow Cancer Hospital Care Center at Long Ridge
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          • Matthew Austin
      • Torrington, Connecticut, Forente stater, 06790
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        • Smilow Cancer Hospital-Torrington Care Center
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        • Hovedetterforsker:
          • Matthew Austin
      • Trumbull, Connecticut, Forente stater, 06611
        • Rekruttering
        • Smilow Cancer Hospital Care Center-Trumbull
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        • Hovedetterforsker:
          • Matthew Austin
      • Waterbury, Connecticut, Forente stater, 06708
        • Rekruttering
        • Smilow Cancer Hospital-Waterbury Care Center
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        • Hovedetterforsker:
          • Matthew Austin
      • Waterford, Connecticut, Forente stater, 06385
        • Rekruttering
        • Smilow Cancer Hospital Care Center - Waterford
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        • Hovedetterforsker:
          • Matthew Austin
    • Florida
      • Fort Lauderdale, Florida, Forente stater, 33308
        • Rekruttering
        • Holy Cross Hospital
        • Hovedetterforsker:
          • Tareq Al baghdadi
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      • Jacksonville, Florida, Forente stater, 32224-9980
        • Rekruttering
        • Mayo Clinic in Florida
        • Hovedetterforsker:
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          • Telefonnummer: 855-776-0015
      • Tampa, Florida, Forente stater, 33612
        • Rekruttering
        • Moffitt Cancer Center
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        • Hovedetterforsker:
          • Mintallah Haider
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96813
        • Rekruttering
        • Hawaii Cancer Care Inc - Waterfront Plaza
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        • Hovedetterforsker:
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      • Honolulu, Hawaii, Forente stater, 96813
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        • Queen's Cancer Cenrer - POB I
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          • Site Public Contact
          • Telefonnummer: 808-532-0315
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      • Honolulu, Hawaii, Forente stater, 96813
        • Rekruttering
        • Queen's Medical Center
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          • Telefonnummer: 808-545-8548
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      • Honolulu, Hawaii, Forente stater, 96813
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        • Straub Clinic and Hospital
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        • Hovedetterforsker:
          • Elizabeth S. Nakasone
      • Honolulu, Hawaii, Forente stater, 96813
        • Rekruttering
        • University of Hawaii Cancer Center
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          • Site Public Contact
          • Telefonnummer: 808-586-2979
        • Hovedetterforsker:
          • Elizabeth S. Nakasone
      • Honolulu, Hawaii, Forente stater, 96817
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        • Queen's Cancer Center - Kuakini
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          • Telefonnummer: 808-531-8521
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          • Elizabeth S. Nakasone
      • ‘Aiea, Hawaii, Forente stater, 96701
        • Rekruttering
        • Hawaii Cancer Care - Westridge
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      • ‘Aiea, Hawaii, Forente stater, 96701
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      • ‘Ewa Beach, Hawaii, Forente stater, 96706
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        • The Queen's Medical Center - West Oahu
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          • Elizabeth S. Nakasone
    • Idaho
      • Coeur d'Alene, Idaho, Forente stater, 83814
        • Rekruttering
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          • John M. Schallenkamp
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      • Nampa, Idaho, Forente stater, 83687
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        • Saint Alphonsus Cancer Care Center-Nampa
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          • Tareq Al baghdadi
      • Post Falls, Idaho, Forente stater, 83854
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        • Kootenai Clinic Cancer Services - Post Falls
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          • John M. Schallenkamp
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      • Sandpoint, Idaho, Forente stater, 83864
        • Rekruttering
        • Kootenai Clinic Cancer Services - Sandpoint
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    • Illinois
      • Aurora, Illinois, Forente stater, 60504
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        • Rush-Copley Medical Center
      • Centralia, Illinois, Forente stater, 62801
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        • Centralia Oncology Clinic
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          • Bryan A. Faller
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      • Chicago, Illinois, Forente stater, 60637
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        • University of Chicago Comprehensive Cancer Center
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        • Hovedetterforsker:
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      • Chicago, Illinois, Forente stater, 60611
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        • Northwestern University
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      • Danville, Illinois, Forente stater, 61832
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      • DeKalb, Illinois, Forente stater, 60115
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        • Northwestern Medicine Cancer Center Kishwaukee
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      • Decatur, Illinois, Forente stater, 62526
        • Rekruttering
        • Cancer Care Specialists of Illinois - Decatur
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      • Decatur, Illinois, Forente stater, 62526
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        • Decatur Memorial Hospital
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      • Effingham, Illinois, Forente stater, 62401
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        • Carle Physician Group-Effingham
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      • Effingham, Illinois, Forente stater, 62401
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        • Crossroads Cancer Center
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          • Bryan A. Faller
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      • Geneva, Illinois, Forente stater, 60134
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        • Northwestern Medicine Cancer Center Delnor
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      • Glenview, Illinois, Forente stater, 60026
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        • Northwestern Medicine Glenview Outpatient Center
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      • Grayslake, Illinois, Forente stater, 60030
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        • Northwestern Medicine Grayslake Outpatient Center
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      • Harvey, Illinois, Forente stater, 60426
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        • Ingalls Memorial Hospital
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        • Northwestern Medicine Lake Forest Hospital
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      • Mattoon, Illinois, Forente stater, 61938
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        • Carle Physician Group-Mattoon/Charleston
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        • Hovedetterforsker:
          • Vamsi K. Vasireddy
      • Mount Vernon, Illinois, Forente stater, 62864
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        • SSM Health Good Samaritan
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        • Ta kontakt med:
      • New Lenox, Illinois, Forente stater, 60451
        • Rekruttering
        • UC Comprehensive Cancer Center at Silver Cross
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        • Hovedetterforsker:
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      • Normal, Illinois, Forente stater, 61761
        • Rekruttering
        • Carle BroMenn Medical Center
        • Hovedetterforsker:
          • Vamsi K. Vasireddy
        • Ta kontakt med:
      • Normal, Illinois, Forente stater, 61761
        • Rekruttering
        • Carle Cancer Institute Normal
        • Hovedetterforsker:
          • Vamsi K. Vasireddy
        • Ta kontakt med:
      • O'Fallon, Illinois, Forente stater, 62269
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        • Cancer Care Center of O'Fallon
        • Hovedetterforsker:
          • Bryan A. Faller
        • Ta kontakt med:
      • Orland Park, Illinois, Forente stater, 60462
        • Rekruttering
        • University of Chicago Medicine-Orland Park
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        • Hovedetterforsker:
          • Ardaman Shergill
      • Orland Park, Illinois, Forente stater, 60462
      • Rockford, Illinois, Forente stater, 61114
        • Rekruttering
        • UW Health Carbone Cancer Center Rockford
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        • Hovedetterforsker:
          • Fahrettin Covut
      • Springfield, Illinois, Forente stater, 62702
        • Rekruttering
        • Southern Illinois University School of Medicine
        • Hovedetterforsker:
          • Bryan A. Faller
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 217-545-7929
      • Springfield, Illinois, Forente stater, 62702
        • Rekruttering
        • Springfield Clinic
        • Hovedetterforsker:
          • Bryan A. Faller
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 800-444-7541
      • Springfield, Illinois, Forente stater, 62781
        • Rekruttering
        • Springfield Memorial Hospital
        • Hovedetterforsker:
          • Bryan A. Faller
        • Ta kontakt med:
      • Urbana, Illinois, Forente stater, 61801
        • Rekruttering
        • Carle Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Vamsi K. Vasireddy
      • Warrenville, Illinois, Forente stater, 60555
        • Rekruttering
        • Northwestern Medicine Cancer Center Warrenville
        • Hovedetterforsker:
          • Mary F. Mulcahy
        • Ta kontakt med:
      • Yorkville, Illinois, Forente stater, 60560
        • Suspendert
        • Rush-Copley Healthcare Center
    • Indiana
      • Crown Point, Indiana, Forente stater, 46307
        • Rekruttering
        • UChicago Medicine Northwest Indiana
        • Hovedetterforsker:
          • Ardaman Shergill
        • Ta kontakt med:
    • Iowa
      • Ames, Iowa, Forente stater, 50010
        • Rekruttering
        • Mary Greeley Medical Center
        • Hovedetterforsker:
          • Joseph J. Merchant
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 515-956-4132
      • Ames, Iowa, Forente stater, 50010
        • Rekruttering
        • McFarland Clinic - Ames
        • Hovedetterforsker:
          • Joseph J. Merchant
        • Ta kontakt med:
      • Ankeny, Iowa, Forente stater, 50023
        • Rekruttering
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 515-241-3305
        • Hovedetterforsker:
          • Seema Harichand-Herdt
      • Boone, Iowa, Forente stater, 50036
        • Suspendert
        • McFarland Clinic - Boone
      • Carroll, Iowa, Forente stater, 51401
        • Rekruttering
        • Saint Anthony Regional Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Seema Harichand-Herdt
      • Clive, Iowa, Forente stater, 50325
        • Rekruttering
        • Mercy Cancer Center-West Lakes
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 515-241-3305
        • Hovedetterforsker:
          • Richard L. Deming
      • Clive, Iowa, Forente stater, 50325
        • Rekruttering
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 515-241-3305
        • Hovedetterforsker:
          • Seema Harichand-Herdt
      • Creston, Iowa, Forente stater, 50801
        • Aktiv, ikke rekrutterende
        • Greater Regional Medical Center
      • Des Moines, Iowa, Forente stater, 50314
        • Rekruttering
        • Broadlawns Medical Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 515-282-2200
        • Hovedetterforsker:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Forente stater, 50314
        • Rekruttering
        • Mercy Medical Center - Des Moines
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 515-241-3305
        • Hovedetterforsker:
          • Richard L. Deming
      • Des Moines, Iowa, Forente stater, 50309
        • Rekruttering
        • Iowa Methodist Medical Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 515-241-6727
        • Hovedetterforsker:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Forente stater, 50309
        • Rekruttering
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 515-241-3305
        • Hovedetterforsker:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Forente stater, 50314
        • Rekruttering
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 515-241-3305
        • Hovedetterforsker:
          • Seema Harichand-Herdt
      • Fort Dodge, Iowa, Forente stater, 50501
        • Rekruttering
        • McFarland Clinic - Trinity Cancer Center
        • Hovedetterforsker:
          • Joseph J. Merchant
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 515-956-4132
      • Jefferson, Iowa, Forente stater, 50129
        • Suspendert
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, Forente stater, 50158
        • Rekruttering
        • McFarland Clinic - Marshalltown
        • Hovedetterforsker:
          • Joseph J. Merchant
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 515-956-4132
      • Waukee, Iowa, Forente stater, 50263
        • Rekruttering
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 515-241-3305
        • Hovedetterforsker:
          • Seema Harichand-Herdt
      • West Des Moines, Iowa, Forente stater, 50266
        • Rekruttering
        • Mercy Medical Center-West Lakes
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 515-241-3305
        • Hovedetterforsker:
          • Richard L. Deming
    • Louisiana
      • Baton Rouge, Louisiana, Forente stater, 70805
        • Rekruttering
        • LSU Health Baton Rouge-North Clinic
        • Ta kontakt med:
        • Hovedetterforsker:
          • Marshall P. Stagg
      • Baton Rouge, Louisiana, Forente stater, 70808
        • Rekruttering
        • Our Lady of the Lake Physician Group
        • Ta kontakt med:
        • Hovedetterforsker:
          • Marshall P. Stagg
      • Metairie, Louisiana, Forente stater, 70006
        • Rekruttering
        • East Jefferson General Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tara Castellano
      • Metairie, Louisiana, Forente stater, 70006
        • Rekruttering
        • LSU Healthcare Network / Metairie Multi-Specialty Clinic
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tara Castellano
      • New Orleans, Louisiana, Forente stater, 70112
        • Rekruttering
        • University Medical Center New Orleans
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tara Castellano
    • Massachusetts
      • Burlington, Massachusetts, Forente stater, 01805
      • Peabody, Massachusetts, Forente stater, 01960
        • Rekruttering
        • Lahey Clinic Peabody
        • Ta kontakt med:
        • Hovedetterforsker:
          • Andrew Piper-Vallillo
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • Rekruttering
        • University of Michigan Rogel Cancer Center
        • Hovedetterforsker:
          • Vaibhav Sahai
        • Ta kontakt med:
      • Ann Arbor, Michigan, Forente stater, 48106
        • Rekruttering
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tareq Al baghdadi
      • Battle Creek, Michigan, Forente stater, 49017
        • Rekruttering
        • Bronson Battle Creek
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathleen Y. Butler
      • Brighton, Michigan, Forente stater, 48114
        • Rekruttering
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tareq Al baghdadi
      • Brighton, Michigan, Forente stater, 48114
        • Rekruttering
        • Trinity Health Medical Center - Brighton
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tareq Al baghdadi
      • Brownstown, Michigan, Forente stater, 48183
        • Rekruttering
        • Henry Ford Cancer Institute-Downriver
        • Ta kontakt med:
        • Hovedetterforsker:
          • Haythem Y. Ali
      • Canton, Michigan, Forente stater, 48188
        • Rekruttering
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tareq Al baghdadi
      • Canton, Michigan, Forente stater, 48188
        • Rekruttering
        • Trinity Health Medical Center - Canton
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tareq Al baghdadi
      • Chelsea, Michigan, Forente stater, 48118
        • Rekruttering
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tareq Al baghdadi
      • Chelsea, Michigan, Forente stater, 48118
      • Clinton Township, Michigan, Forente stater, 48038
        • Rekruttering
        • Henry Ford Macomb Hospital-Clinton Township
        • Ta kontakt med:
        • Hovedetterforsker:
          • Haythem Y. Ali
      • Dearborn, Michigan, Forente stater, 48126
        • Rekruttering
        • Henry Ford Medical Center-Fairlane
        • Ta kontakt med:
        • Hovedetterforsker:
          • Haythem Y. Ali
      • Dearborn, Michigan, Forente stater, 48124
        • Rekruttering
        • Corewell Health Dearborn Hospital
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 248-551-7695
        • Hovedetterforsker:
          • Andrew A. Muskovitz
      • Detroit, Michigan, Forente stater, 48202
        • Rekruttering
        • Henry Ford Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Haythem Y. Ali
      • Detroit, Michigan, Forente stater, 48201
        • Aktiv, ikke rekrutterende
        • Wayne State University/Karmanos Cancer Institute
      • Detroit, Michigan, Forente stater, 48236
        • Rekruttering
        • Henry Ford Health Saint John Hospital
        • Hovedetterforsker:
          • Tareq Al baghdadi
        • Ta kontakt med:
      • East China Township, Michigan, Forente stater, 48054
        • Rekruttering
        • Henry Ford River District Hospital
        • Hovedetterforsker:
          • Tareq Al baghdadi
        • Ta kontakt med:
      • Farmington Hills, Michigan, Forente stater, 48334
        • Aktiv, ikke rekrutterende
        • Weisberg Cancer Treatment Center
      • Farmington Hills, Michigan, Forente stater, 48336
        • Rekruttering
        • Corewell Health Farmington Hills Hospital
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 248-551-7695
        • Hovedetterforsker:
          • Andrew A. Muskovitz
      • Flint, Michigan, Forente stater, 48503
        • Rekruttering
        • Genesys Hurley Cancer Institute
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tareq Al baghdadi
      • Flint, Michigan, Forente stater, 48503
        • Rekruttering
        • Hurley Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tareq Al baghdadi
      • Flint, Michigan, Forente stater, 48503
        • Suspendert
        • Genesee Hematology Oncology PC
      • Flint, Michigan, Forente stater, 48503
        • Rekruttering
        • Cancer Hematology Centers - Flint
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tareq Al baghdadi
      • Grand Rapids, Michigan, Forente stater, 49503
        • Rekruttering
        • Trinity Health Grand Rapids Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tareq Al baghdadi
      • Grand Rapids, Michigan, Forente stater, 49503
        • Rekruttering
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathleen Y. Butler
      • Grosse Pointe Woods, Michigan, Forente stater, 48236
        • Rekruttering
        • Henry Ford Saint John Hospital - Breast
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tareq Al baghdadi
      • Grosse Pointe Woods, Michigan, Forente stater, 48236
        • Rekruttering
        • Henry Ford Saint John Hospital - Academic
        • Hovedetterforsker:
          • Tareq Al baghdadi
        • Ta kontakt med:
      • Grosse Pointe Woods, Michigan, Forente stater, 48236
        • Rekruttering
        • Henry Ford Saint John Hospital - Van Elslander
        • Hovedetterforsker:
          • Tareq Al baghdadi
        • Ta kontakt med:
      • Jackson, Michigan, Forente stater, 49201
        • Rekruttering
        • Allegiance Health
        • Ta kontakt med:
        • Hovedetterforsker:
          • Haythem Y. Ali
      • Kalamazoo, Michigan, Forente stater, 49007
        • Rekruttering
        • Bronson Methodist Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, Forente stater, 49007
        • Rekruttering
        • West Michigan Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathleen Y. Butler
      • Lansing, Michigan, Forente stater, 48910
        • Aktiv, ikke rekrutterende
        • Karmanos Cancer Institute at McLaren Greater Lansing
      • Livonia, Michigan, Forente stater, 48154
        • Rekruttering
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tareq Al baghdadi
      • Macomb, Michigan, Forente stater, 48044
        • Rekruttering
        • Henry Ford Warren Hospital - Breast Macomb
        • Hovedetterforsker:
          • Tareq Al baghdadi
        • Ta kontakt med:
      • Macomb, Michigan, Forente stater, 48044
        • Rekruttering
        • Henry Ford Saint John Hospital - Macomb Medical
        • Hovedetterforsker:
          • Tareq Al baghdadi
        • Ta kontakt med:
      • Muskegon, Michigan, Forente stater, 49444
        • Rekruttering
        • Trinity Health Muskegon Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tareq Al baghdadi
      • Niles, Michigan, Forente stater, 49120
        • Rekruttering
        • Corewell Health Lakeland Hospitals - Niles Hospital
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 616-391-1230
        • Hovedetterforsker:
          • Kathleen Y. Butler
      • Norton Shores, Michigan, Forente stater, 49444
        • Suspendert
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
      • Novi, Michigan, Forente stater, 48377
        • Rekruttering
        • Henry Ford Medical Center-Columbus
        • Ta kontakt med:
        • Hovedetterforsker:
          • Haythem Y. Ali
      • Pontiac, Michigan, Forente stater, 48341
        • Rekruttering
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tareq Al baghdadi
      • Reed City, Michigan, Forente stater, 49677
        • Rekruttering
        • Corewell Health Reed City Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathleen Y. Butler
      • Royal Oak, Michigan, Forente stater, 48073
        • Rekruttering
        • Corewell Health William Beaumont University Hospital
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 248-551-7695
        • Hovedetterforsker:
          • Andrew A. Muskovitz
      • Saint Joseph, Michigan, Forente stater, 49085
        • Rekruttering
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathleen Y. Butler
      • Saint Joseph, Michigan, Forente stater, 49085
        • Rekruttering
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathleen Y. Butler
      • Traverse City, Michigan, Forente stater, 49684
        • Rekruttering
        • Munson Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathleen Y. Butler
      • Troy, Michigan, Forente stater, 48085
        • Rekruttering
        • Corewell Health Beaumont Troy Hospital
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 248-551-7695
        • Hovedetterforsker:
          • Andrew A. Muskovitz
      • Warren, Michigan, Forente stater, 48093
        • Rekruttering
        • Henry Ford Madison Heights Hospital - Breast
        • Hovedetterforsker:
          • Tareq Al baghdadi
        • Ta kontakt med:
      • Warren, Michigan, Forente stater, 48093
        • Rekruttering
        • Henry Ford Health Warren Hospital
        • Hovedetterforsker:
          • Tareq Al baghdadi
        • Ta kontakt med:
      • Warren, Michigan, Forente stater, 48093
        • Rekruttering
        • Henry Ford Warren Hospital - GLCMS
        • Hovedetterforsker:
          • Tareq Al baghdadi
        • Ta kontakt med:
      • West Bloomfield, Michigan, Forente stater, 48322
        • Rekruttering
        • Henry Ford West Bloomfield Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Haythem Y. Ali
      • Wyandotte, Michigan, Forente stater, 48192
        • Rekruttering
        • Henry Ford Wyandotte Hospital
        • Hovedetterforsker:
          • Haythem Y. Ali
        • Ta kontakt med:
      • Wyoming, Michigan, Forente stater, 49519
        • Rekruttering
        • University of Michigan Health - West
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathleen Y. Butler
      • Ypsilanti, Michigan, Forente stater, 48106
      • Ypsilanti, Michigan, Forente stater, 48197
        • Rekruttering
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tareq Al baghdadi
    • Minnesota
      • Burnsville, Minnesota, Forente stater, 55337
        • Rekruttering
        • Minnesota Oncology - Burnsville
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Duluth, Minnesota, Forente stater, 55805
        • Aktiv, ikke rekrutterende
        • Saint Luke's Hospital of Duluth
      • Edina, Minnesota, Forente stater, 55435
        • Rekruttering
        • Fairview Southdale Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Edina, Minnesota, Forente stater, 55435
        • Rekruttering
        • Minnesota Oncology - Edina
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Minneapolis, Minnesota, Forente stater, 55407
        • Rekruttering
        • Abbott-Northwestern Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Minneapolis, Minnesota, Forente stater, 55415
        • Rekruttering
        • Hennepin County Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Rochester, Minnesota, Forente stater, 55905
        • Rekruttering
        • Mayo Clinic in Rochester
        • Hovedetterforsker:
          • Jacob Orme
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 855-776-0015
      • Saint Louis Park, Minnesota, Forente stater, 55416
        • Rekruttering
        • Park Nicollet Clinic - Saint Louis Park
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Saint Paul, Minnesota, Forente stater, 55101
        • Rekruttering
        • Regions Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Saint Paul, Minnesota, Forente stater, 55102
        • Rekruttering
        • United Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
      • Shakopee, Minnesota, Forente stater, 55379
        • Rekruttering
        • Saint Francis Regional Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • David M. King
    • Missouri
      • Cape Girardeau, Missouri, Forente stater, 63703
        • Rekruttering
        • Saint Francis Medical Center
        • Hovedetterforsker:
          • Bryan A. Faller
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 573-334-2230
          • E-post: sfmc@sfmc.net
      • Joplin, Missouri, Forente stater, 64804
        • Rekruttering
        • Mercy Hospital Joplin
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
      • Springfield, Missouri, Forente stater, 65804
        • Rekruttering
        • Mercy Hospital Springfield
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 417-269-4520
      • Springfield, Missouri, Forente stater, 65807
        • Rekruttering
        • CoxHealth South Hospital
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 417-269-4520
      • St Louis, Missouri, Forente stater, 63128
        • Rekruttering
        • Mercy Hospital South
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
    • Montana
      • Anaconda, Montana, Forente stater, 59711
        • Rekruttering
        • Community Hospital of Anaconda
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
      • Billings, Montana, Forente stater, 59101
        • Rekruttering
        • Billings Clinic Cancer Center
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
      • Billings, Montana, Forente stater, 59102
        • Rekruttering
        • Saint Vincent Frontier Cancer Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 800-648-6274
        • Hovedetterforsker:
          • Patrick W. Cobb
      • Great Falls, Montana, Forente stater, 59405
        • Rekruttering
        • Benefis Sletten Cancer Institute
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
      • Kalispell, Montana, Forente stater, 59901
        • Rekruttering
        • Logan Health Medical Center
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
      • Missoula, Montana, Forente stater, 59804
        • Rekruttering
        • Community Medical Center
        • Hovedetterforsker:
          • John M. Schallenkamp
        • Ta kontakt med:
    • New Hampshire
      • Lebanon, New Hampshire, Forente stater, 03756
        • Rekruttering
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathryn C. Hourdequin
    • New York
      • Buffalo, New York, Forente stater, 14263
        • Aktiv, ikke rekrutterende
        • Roswell Park Cancer Institute
      • New York, New York, Forente stater, 10029
        • Aktiv, ikke rekrutterende
        • Mount Sinai Hospital
      • Stony Brook, New York, Forente stater, 11794
        • Aktiv, ikke rekrutterende
        • Stony Brook University Medical Center
    • North Carolina
      • Cary, North Carolina, Forente stater, 27518
        • Suspendert
        • Duke Cancer Center Cary
      • Charlotte, North Carolina, Forente stater, 28203
        • Rekruttering
        • Carolinas Medical Center/Levine Cancer Institute
        • Hovedetterforsker:
          • Earle F. Burgess
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 800-804-9376
      • Charlotte, North Carolina, Forente stater, 28210
        • Rekruttering
        • Atrium Health Pineville/LCI-Pineville
        • Hovedetterforsker:
          • Earle F. Burgess
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 980-442-2000
      • Charlotte, North Carolina, Forente stater, 28211
        • Rekruttering
        • Levine Cancer Institute-SouthPark
        • Hovedetterforsker:
          • Earle F. Burgess
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 980-442-2000
      • Charlotte, North Carolina, Forente stater, 28262
        • Rekruttering
        • Atrium Health University City/LCI-University
        • Hovedetterforsker:
          • Earle F. Burgess
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 800-804-9376
      • Charlotte, North Carolina, Forente stater, 28277
        • Rekruttering
        • Levine Cancer Institute-Ballantyne
        • Hovedetterforsker:
          • Earle F. Burgess
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 800-804-9376
      • Clinton, North Carolina, Forente stater, 28328
        • Rekruttering
        • Southeastern Medical Oncology Center-Clinton
        • Ta kontakt med:
        • Hovedetterforsker:
          • Samer S. Kasbari
      • Concord, North Carolina, Forente stater, 28025
        • Rekruttering
        • Atrium Health Cabarrus/LCI-Concord
        • Hovedetterforsker:
          • Earle F. Burgess
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 800-804-9376
      • Durham, North Carolina, Forente stater, 27710
        • Rekruttering
        • Duke University Medical Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 888-275-3853
        • Hovedetterforsker:
          • Tucker Coston
      • Gastonia, North Carolina, Forente stater, 28054
        • Rekruttering
        • Levine Cancer Institute-Gaston
        • Hovedetterforsker:
          • Earle F. Burgess
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 800-804-9376
      • Goldsboro, North Carolina, Forente stater, 27534
        • Rekruttering
        • Southeastern Medical Oncology Center-Goldsboro
        • Ta kontakt med:
        • Hovedetterforsker:
          • Samer S. Kasbari
      • Jacksonville, North Carolina, Forente stater, 28546
        • Rekruttering
        • Southeastern Medical Oncology Center-Jacksonville
        • Hovedetterforsker:
          • Samer S. Kasbari
        • Ta kontakt med:
      • Pinehurst, North Carolina, Forente stater, 28374
        • Rekruttering
        • FirstHealth of the Carolinas-Moore Regional Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Charles S. Kuzma
      • Raleigh, North Carolina, Forente stater, 27609
        • Rekruttering
        • Duke Cancer Center Raleigh
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tucker Coston
      • Shelby, North Carolina, Forente stater, 28150
        • Rekruttering
        • Atrium Health Cleveland/LCI-Cleveland
        • Hovedetterforsker:
          • Earle F. Burgess
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 800-804-9376
    • Ohio
      • Columbus, Ohio, Forente stater, 43210
        • Rekruttering
        • Ohio State University Comprehensive Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bhavana Konda
      • Toledo, Ohio, Forente stater, 43623
        • Suspendert
        • Toledo Clinic Cancer Centers-Toledo
    • Oklahoma
      • Lawton, Oklahoma, Forente stater, 73505
        • Rekruttering
        • Cancer Centers of Southwest Oklahoma Research
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 877-231-4440
        • Hovedetterforsker:
          • Sagila George
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • Rekruttering
        • University of Oklahoma Health Sciences Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sagila George
      • Oklahoma City, Oklahoma, Forente stater, 73120
        • Rekruttering
        • Mercy Hospital Oklahoma City
        • Hovedetterforsker:
          • Jay W. Carlson
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 405-752-3402
    • Oregon
      • Bend, Oregon, Forente stater, 97701
        • Rekruttering
        • Saint Charles Health System
        • Ta kontakt med:
        • Hovedetterforsker:
          • Charles W. Drescher
      • Clackamas, Oregon, Forente stater, 97015
        • Suspendert
        • Providence Cancer Institute Clackamas Clinic
      • Newberg, Oregon, Forente stater, 97132
        • Rekruttering
        • Providence Newberg Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Charles W. Drescher
      • Oregon City, Oregon, Forente stater, 97045
        • Rekruttering
        • Providence Willamette Falls Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Charles W. Drescher
      • Portland, Oregon, Forente stater, 97213
        • Rekruttering
        • Providence Portland Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Charles W. Drescher
      • Portland, Oregon, Forente stater, 97225
        • Rekruttering
        • Providence Saint Vincent Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Charles W. Drescher
    • Pennsylvania
      • Chambersburg, Pennsylvania, Forente stater, 17201
        • Rekruttering
        • WellSpan Medical Oncology and Hematology
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 717-217-6020
        • Hovedetterforsker:
          • Marianne Spengler
      • Ephrata, Pennsylvania, Forente stater, 17522
        • Rekruttering
        • Ephrata Cancer Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 717-721-4840
        • Hovedetterforsker:
          • Marianne Spengler
      • Gettysburg, Pennsylvania, Forente stater, 17325
        • Rekruttering
        • Adams Cancer Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 877-441-7957
        • Hovedetterforsker:
          • Marianne Spengler
      • Hanover, Pennsylvania, Forente stater, 17331
        • Rekruttering
        • WellSpan Medical Oncology and Hematology
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 717-632-1559
        • Hovedetterforsker:
          • Marianne Spengler
      • Lebanon, Pennsylvania, Forente stater, 17042
        • Rekruttering
        • Sechler Family Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Marianne Spengler
      • York, Pennsylvania, Forente stater, 17403
        • Rekruttering
        • WellSpan Health-York Cancer Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 877-441-7957
        • Hovedetterforsker:
          • Marianne Spengler
      • York, Pennsylvania, Forente stater, 17403
        • Suspendert
        • Cancer Care Associates of York
    • Rhode Island
      • Westerly, Rhode Island, Forente stater, 02891
        • Rekruttering
        • Smilow Cancer Hospital Care Center - Westerly
        • Ta kontakt med:
        • Hovedetterforsker:
          • Matthew Austin
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Suspendert
        • Medical University of South Carolina
      • Rock Hill, South Carolina, Forente stater, 29732
        • Rekruttering
        • Levine Cancer Institute-Rock Hill
        • Hovedetterforsker:
          • Earle F. Burgess
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 800-804-9376
    • South Dakota
      • Rapid City, South Dakota, Forente stater, 57701
        • Rekruttering
        • Rapid City Regional Hospital
        • Hovedetterforsker:
          • Abdel-Ghani Azzouqa
        • Ta kontakt med:
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232
        • Rekruttering
        • Vanderbilt University/Ingram Cancer Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 800-811-8480
        • Hovedetterforsker:
          • Robert A. Ramirez
    • Texas
      • Dallas, Texas, Forente stater, 75390
        • Rekruttering
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Ta kontakt med:
        • Hovedetterforsker:
          • Namrata I. Peswani
      • Dallas, Texas, Forente stater, 75235
        • Rekruttering
        • Parkland Memorial Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Namrata I. Peswani
      • Dallas, Texas, Forente stater, 75237
        • Rekruttering
        • UT Southwestern Simmons Cancer Center - RedBird
        • Hovedetterforsker:
          • Namrata I. Peswani
        • Ta kontakt med:
      • Fort Worth, Texas, Forente stater, 76104
        • Rekruttering
        • UT Southwestern/Simmons Cancer Center-Fort Worth
        • Ta kontakt med:
        • Hovedetterforsker:
          • Namrata I. Peswani
      • Houston, Texas, Forente stater, 77030
        • Rekruttering
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
        • Hovedetterforsker:
          • Tannaz Armaghany
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 713-798-1354
          • E-post: burton@bcm.edu
      • Houston, Texas, Forente stater, 77030
        • Rekruttering
        • Ben Taub General Hospital
        • Hovedetterforsker:
          • Tannaz Armaghany
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 713-873-2000
      • Richardson, Texas, Forente stater, 75080
        • Rekruttering
        • UT Southwestern Clinical Center at Richardson/Plano
        • Ta kontakt med:
        • Hovedetterforsker:
          • Namrata I. Peswani
    • Utah
      • Salt Lake City, Utah, Forente stater, 84112
        • Rekruttering
        • Huntsman Cancer Institute/University of Utah
        • Ta kontakt med:
        • Hovedetterforsker:
          • Heloisa P. Soares
    • Vermont
      • Saint Johnsbury, Vermont, Forente stater, 05819
        • Rekruttering
        • Dartmouth Cancer Center - North
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathryn C. Hourdequin
    • Washington
      • Seattle, Washington, Forente stater, 98195
        • Rekruttering
        • University of Washington Medical Center - Montlake
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 800-804-8824
        • Hovedetterforsker:
          • David B. Zhen
      • Seattle, Washington, Forente stater, 98109
        • Rekruttering
        • Fred Hutchinson Cancer Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 800-804-8824
        • Hovedetterforsker:
          • David B. Zhen
    • West Virginia
      • Bridgeport, West Virginia, Forente stater, 26330
        • Rekruttering
        • United Hospital Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Nour Daboul
      • Morgantown, West Virginia, Forente stater, 26506
        • Rekruttering
        • West Virginia University Healthcare
        • Ta kontakt med:
        • Hovedetterforsker:
          • Nour Daboul
    • Wisconsin
      • Eau Claire, Wisconsin, Forente stater, 54701
      • La Crosse, Wisconsin, Forente stater, 54601
        • Rekruttering
        • Gundersen Lutheran Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • David E. Marinier
      • Marshfield, Wisconsin, Forente stater, 54449
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Rekruttering
        • Medical College of Wisconsin
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 414-805-3666
        • Hovedetterforsker:
          • Alexandria T. Phan
      • Minocqua, Wisconsin, Forente stater, 54548
      • Rice Lake, Wisconsin, Forente stater, 54868
      • Stevens Point, Wisconsin, Forente stater, 54482
      • Weston, Wisconsin, Forente stater, 54476

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Participants must have histologically-confirmed (local site pathological confirmation sufficient) extrapulmonary poorly differentiated, neuroendocrine carcinoma (NEC)

  • Participants must have disease that is unresectable or metastatic and not eligible for definitive therapy as deemed per the treating investigator

  • Participants must have radiologically evaluable disease, measurable or non-measurable, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. All measurable and nonmeasurable lesions must be assessed by CT scan with IV contrast of the chest/abdomen/and pelvis (or CT chest without contrast and MRI abdomen/pelvis with gadolinium contrast, if contraindication to CT iodinated contrast) within 28 days prior to registration. While may be used for routine clinical evaluation, PET scans and bone scans alone are not acceptable for disease assessment while participating in this study. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form

  • Participants must have brain MRI (or CT head with contrast if there is contraindication to MRI brain) if clinically indicated within 28 days prior to registration. Note: Brain imaging is not required in participants without known and/or clinical concern for brain metastases. Participants with asymptomatic central nervous system (CNS) metastases are eligible if one or more of the following apply:

    • Participants who have received treatment for brain metastases must have:

      • No evidence of radiological progression (by MRI brain or CT head with contrast if there is contraindication to MRI brain) within 28 days prior to registration
      • Discontinued all corticosteroids at least 14 days prior to registration

    • Participants with treatment-naive brain lesions must have:

      • No lesion measuring > 2.0 cm in size in any axis
      • MRI brain or CT head with contrast (if there is contraindication to MRI brain) demonstrating no evidence for mass effect, edema, or other impending neurological compromise within 28 days prior to registration
      • No evidence of radiological progression (by MRI brain or CT head with contrast if there is contraindication to MRI brain) within 28 days prior to registration
      • No need for > 2 mg of dexamethasone (or equivalent of > 10 mg prednisone) per day at time of registration

  • Participants must not have symptomatic central nervous system (CNS) metastases

  • Participants must not have known or suspected leptomeningeal disease

  • Participants with prior history of non-metastatic (localized/locally advanced disease) extrapulmonary poorly differentiated NEC may have had prior platinum-based therapy +/- radiation +/- surgery provided that all therapy was completed >= 6 months prior to registration

  • Participants must discontinue denosumab prior to study registration and plan to replace with a bisphosphonate while on the study

  • Participants must not have had prior treatment for advanced or metastatic NEC EXCEPT one cycle of platinum (carboplatin/cisplatin) + etoposide is allowed prior to registration. Other chemotherapy regimens are not allowed. For participants with prostate or urothelial NEC, prior chemotherapy for the non-NEC component (e.g. adenocarcinoma or urothelial) is allowed as long as such therapy was completed >= 24 weeks prior to registration and participants have recovered from all prior toxicities to =< grade 1.

  • Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, antiPD-L2, CD137 agonists, anti-CTLA-4 agent, or any other immune checkpoint inhibitors for any neuroendocrine neoplasm. Immune checkpoint inhibitors given for other cancer indications are allowed provided last therapy was given at least 12 months prior to study registration

  • Participants must not have received treatment with systemic immunostimulatory agents including, but not limited to, interferon and interleukin2 [IL-2] within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to registration

  • Participants must not have had history of known severe allergy, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies, including to Chinese hamster ovary cell products or to any component of the atezolizumab formulation, cisplatin, carboplatin, or etoposide

  • Participants must not be on active systemic therapy for another cancer with the exception of hormonal therapy including androgen deprivation therapy (e.g., gonadotropin-releasing hormone [GnRH] agonists or antagonists), which can be continued while participants are receiving protocol therapy. Use of enzalutamide or apalutamide is permitted after completion of chemotherapy and must be held during chemotherapy for participants receiving prior to enrollment. Use of darolutamide is permitted during chemotherapy. Glucocorticoid-containing regimens, including abiraterone, are not permitted.

  • Participants must be >= 18 years of age

  • Participants must have a Zubrod performance status of =< 2 within 28 days prior to registration

  • Participants must have a complete medical history and physical exam within 28 days prior to registration

  • Absolute neutrophil count (ANC) >= 1.5 x 10^9 /L (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)

  • Hemoglobin >= 9.0 g/dl (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)

  • Platelet count >= 100 x 10^9/L (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)

  • Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)

  • Serum total bilirubin =< 1.5 x ULN (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)

  • Adequate renal function as defined by any 1 of the following: 1) Measured creatinine clearance (CL) > 50 mL/min OR 2) Calculated creatinine CL > 50 mL/min by the Cockcroft-Gault formula OR by 24-hour urine collection for determination of creatinine clearance (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)

  • Participants must not have uncontrolled or symptomatic hypercalcemia (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or corrected serum calcium > ULN) within 14 days prior to registration. Participants who have asymptomatic hypercalcemia are eligible provided that medical therapy to treat the hypercalcemia is planned

  • Participants must not have a diagnosis of immunodeficiency nor be receiving systemic steroid therapy (equivalent of > 20 mg of hydrocortisone per day) or any other form of immunosuppressive therapy within 14 days prior to registration

  • Participants must not have active or history of autoimmune disease or immune deficiency, including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis with the following exceptions:

    • Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study

    • Patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study

    • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:

      • Rash must cover < 10% of body surface area
      • Disease is well controlled at baseline and requires only low-potency topical corticosteroids
      • No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months

  • Participants must not have history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. NOTE: History of radiation pneumonitis in the radiation field (fibrosis) is permitted

  • Participants must not have significant cardiovascular disease, such as New York Heart Association class II or greater cardiac disease, myocardial infarction within 3 months prior to registration, unstable arrythmias, or unstable angina

  • Participants must not have had a major surgical procedure other than for diagnosis within 28 days prior to registration. Participant must not plan to receive a major surgical procedure during the course of protocol treatment. NOTE: Patient port placement is not considered a major surgery

  • Participants must not have severe infections (i.e., Common Terminology Criteria for Adverse Events [CTCAE] grade >= 2) at time of registration, including but not limited to hospitalization for complications for infection, bacteremia, or severe pneumonia

  • Participants must not have known active tuberculosis

  • Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load, with testing performed as clinically indicated

  • Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with active HCV infection who are currently on treatment must have an undetectable HCV viral load, with testing performed as clinically indicated

  • Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at time of registration and have undetectable HIV viral load within 6 months of registration

  • Participants must not have prior allogeneic bone marrow transplantation or solid organ transplant

  • Participants must not have received administration of a live, attenuated vaccine (e.g., FluMist [registered trademark]) within 28 days prior to initiation of study treatment, during treatment with atezolizumab, and not plan to receive for 5 months after the last dose of atezolizumab

  • Participants must not be pregnant due to the possibility of harm to the fetus. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method (with details provided as a part of the consent process) during the treatment period and for 5 months after the final dose of atezolizumab. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen

  • Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System

  • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm I (atezolizumab, platinum drug, etoposide)

During induction phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle, and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. During maintenance phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan and/or MRI throughout the trial and blood sample collection on study.
Legemiddel: Carboplatin

Given IV

Andre navn:
  • Blastokarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Karboplatina
  • Karbosin
  • Karbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Platinwas
  • Ribocarbo
  • JM8
Legemiddel: Cisplatin

Given IV

Andre navn:
  • CDDP
  • Cis-diammindikloridplatina
  • Cismaplat
  • Cisplatinum
  • Neoplatin
  • Platinol
  • Abiplatin
  • Blastolem
  • Briplatin
  • Cis-diammin-diklorplatina
  • Cis-diamindiklor platina (II)
  • Cis-diamindiklorplatina
  • Cis-dikloramin platina (II)
  • Cis-platinøs diamin diklorid
  • Cis-platina
  • Cis-platina II
  • Cis-platina II diamin diklorid
  • Cisplatina
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Peyrones klorid
  • Peyrones salt
  • Placis
  • Plastistil
  • Platamin
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platina
  • Platina diaminodiklorid
  • Platiran
  • Platistin
  • Platosin
Fremgangsmåte: Biospecimen Collection

Undergo blood sample collection

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medisinsk bildebehandling, magnetisk resonans / kjernemagnetisk resonans
  • MR Imaging
  • MR-skanning
  • NMR-avbildning
  • NMRI
  • Kjernemagnetisk resonansavbildning
  • Magnetisk resonanstomografi (MR)
  • sMRI
  • Magnetisk resonansavbildning (prosedyre)
  • MR-er
  • Strukturell MR
Legemiddel: Etoposide

Given IV

Andre navn:
  • Demetyl Epipodofyllotoksin Ethylidin Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16
  • VP 16-213
  • VP-16
  • VP-16-213
  • VP16
  • VP 16213
  • VP-16213
  • VP16213
Fremgangsmåte: Computed Tomography

Undergo CT scan

Andre navn:
  • CT
  • KATT
  • CAT-skanning
  • Beregnet aksial tomografi
  • Datastyrt aksialtomografi
  • Datastyrt tomografi
  • CT skann
  • tomografi
  • Datastyrt aksial tomografi (prosedyre)
  • Datastyrt tomografi (CT) skanning
  • Diagnostisk CAT -skanning
  • Diagnostisk CAT -skannertype
Biologisk: Atezolizumab

Given IV

Andre navn:
  • Tecentriq
  • MPDL3280A
  • RO5541267
  • RG7446
  • MPDL 3280A
  • MPDL 328OA
  • MPDL-3280A
  • MPDL328OA
  • RG-7446
  • RG 7446
  • RO 5541267
  • RO-5541267
Eksperimentell: Arm II (atezolizumab, platinum drug, etoposide, observation)

During induction phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle, and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo observation for 1 year. Patients also undergo CT scan and/or MRI throughout the trial and blood sample collection on study. (CLOSED TO ACCRUAL 7/9/26)
Legemiddel: Carboplatin

Given IV

Andre navn:
  • Blastokarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Karboplatina
  • Karbosin
  • Karbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Platinwas
  • Ribocarbo
  • JM8
Legemiddel: Cisplatin

Given IV

Andre navn:
  • CDDP
  • Cis-diammindikloridplatina
  • Cismaplat
  • Cisplatinum
  • Neoplatin
  • Platinol
  • Abiplatin
  • Blastolem
  • Briplatin
  • Cis-diammin-diklorplatina
  • Cis-diamindiklor platina (II)
  • Cis-diamindiklorplatina
  • Cis-dikloramin platina (II)
  • Cis-platinøs diamin diklorid
  • Cis-platina
  • Cis-platina II
  • Cis-platina II diamin diklorid
  • Cisplatina
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Peyrones klorid
  • Peyrones salt
  • Placis
  • Plastistil
  • Platamin
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platina
  • Platina diaminodiklorid
  • Platiran
  • Platistin
  • Platosin
Fremgangsmåte: Biospecimen Collection

Undergo blood sample collection

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medisinsk bildebehandling, magnetisk resonans / kjernemagnetisk resonans
  • MR Imaging
  • MR-skanning
  • NMR-avbildning
  • NMRI
  • Kjernemagnetisk resonansavbildning
  • Magnetisk resonanstomografi (MR)
  • sMRI
  • Magnetisk resonansavbildning (prosedyre)
  • MR-er
  • Strukturell MR
Legemiddel: Etoposide

Given IV

Andre navn:
  • Demetyl Epipodofyllotoksin Ethylidin Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16
  • VP 16-213
  • VP-16
  • VP-16-213
  • VP16
  • VP 16213
  • VP-16213
  • VP16213
Fremgangsmåte: Computed Tomography

Undergo CT scan

Andre navn:
  • CT
  • KATT
  • CAT-skanning
  • Beregnet aksial tomografi
  • Datastyrt aksialtomografi
  • Datastyrt tomografi
  • CT skann
  • tomografi
  • Datastyrt aksial tomografi (prosedyre)
  • Datastyrt tomografi (CT) skanning
  • Diagnostisk CAT -skanning
  • Diagnostisk CAT -skannertype
Annen: Patient Observation

Undergo observation

Andre navn:
  • Observasjon
  • Aktiv overvåking
  • utsatt terapi
  • forventningsfull ledelse
  • Vaken venter
Biologisk: Atezolizumab

Given IV

Andre navn:
  • Tecentriq
  • MPDL3280A
  • RO5541267
  • RG7446
  • MPDL 3280A
  • MPDL 328OA
  • MPDL-3280A
  • MPDL328OA
  • RG-7446
  • RG 7446
  • RO 5541267
  • RO-5541267
Aktiv komparator: Arm III (platinum drug, etoposide, observation)

During induction phase, patients receive carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo observation for 1 year. Patients also undergo CT scan and/or MRI throughout the trial and blood sample collection on study.
Legemiddel: Carboplatin

Given IV

Andre navn:
  • Blastokarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Karboplatina
  • Karbosin
  • Karbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Platinwas
  • Ribocarbo
  • JM8
Legemiddel: Cisplatin

Given IV

Andre navn:
  • CDDP
  • Cis-diammindikloridplatina
  • Cismaplat
  • Cisplatinum
  • Neoplatin
  • Platinol
  • Abiplatin
  • Blastolem
  • Briplatin
  • Cis-diammin-diklorplatina
  • Cis-diamindiklor platina (II)
  • Cis-diamindiklorplatina
  • Cis-dikloramin platina (II)
  • Cis-platinøs diamin diklorid
  • Cis-platina
  • Cis-platina II
  • Cis-platina II diamin diklorid
  • Cisplatina
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Peyrones klorid
  • Peyrones salt
  • Placis
  • Plastistil
  • Platamin
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platina
  • Platina diaminodiklorid
  • Platiran
  • Platistin
  • Platosin
Fremgangsmåte: Biospecimen Collection

Undergo blood sample collection

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medisinsk bildebehandling, magnetisk resonans / kjernemagnetisk resonans
  • MR Imaging
  • MR-skanning
  • NMR-avbildning
  • NMRI
  • Kjernemagnetisk resonansavbildning
  • Magnetisk resonanstomografi (MR)
  • sMRI
  • Magnetisk resonansavbildning (prosedyre)
  • MR-er
  • Strukturell MR
Legemiddel: Etoposide

Given IV

Andre navn:
  • Demetyl Epipodofyllotoksin Ethylidin Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16
  • VP 16-213
  • VP-16
  • VP-16-213
  • VP16
  • VP 16213
  • VP-16213
  • VP16213
Fremgangsmåte: Computed Tomography

Undergo CT scan

Andre navn:
  • CT
  • KATT
  • CAT-skanning
  • Beregnet aksial tomografi
  • Datastyrt aksialtomografi
  • Datastyrt tomografi
  • CT skann
  • tomografi
  • Datastyrt aksial tomografi (prosedyre)
  • Datastyrt tomografi (CT) skanning
  • Diagnostisk CAT -skanning
  • Diagnostisk CAT -skannertype
Annen: Patient Observation

Undergo observation

Andre navn:
  • Observasjon
  • Aktiv overvåking
  • utsatt terapi
  • forventningsfull ledelse
  • Vaken venter

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall survival
Tidsramme: From date of registration or from date of start of observation/maintenance therapy to date of death due to any cause, assessed up to 5 years

Log-rank tests stratified by the randomization stratification factors will be used for null hypothesis (efficacy) tests. Cox regression models stratified by the randomization stratification factors will be used for alternative hypothesis (futility) tests.
From date of registration or from date of start of observation/maintenance therapy to date of death due to any cause, assessed up to 5 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-free survival
Tidsramme: From date of registration or start of observation/maintenance therapy to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 5 years

Will be estimated using the Kaplan-Meier method and compared using log-rank tests.
From date of registration or start of observation/maintenance therapy to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 5 years
Duration of response
Tidsramme: Time from date of initial response to date of progression or death, assessed up to 5 years

Will be estimated non-parametrically using cumulative incidence curves.
Time from date of initial response to date of progression or death, assessed up to 5 years
Objective response rate (confirmed complete response [CR] or partial response [PR])
Tidsramme: Up to 5 years from study enrollment

Will be tabulated and compared between arms using Fisher's exact test.
Up to 5 years from study enrollment
Clinical benefit rate (confirmed CR or PR of any amount of time or stable disease for 6 months or longer)
Tidsramme: Up to 5 years from study enrollment

Will be tabulated and compared between arms using Fisher's exact test.
Up to 5 years from study enrollment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: David B Zhen, SWOG Cancer Research Network

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. juni 2022

Primær fullføring (Antatt)

1. oktober 2028

Studiet fullført (Antatt)

1. oktober 2028

Datoer for studieregistrering

Først innsendt

25. september 2021

Først innsendt som oppfylte QC-kriteriene

25. september 2021

Først lagt ut (Faktiske)

28. september 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. november 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NCI-2021-09851
  • U10CA180888 (U.S. NIH-stipend/kontrakt)
  • NCI-2021-09851 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • S2012 (Annen identifikator: CTEP)
  • S2012 (Annen identifikator: SWOG)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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