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En studie som jämför kombinationen av Pembrolizumab och Sacituzumab Govitecan kontra Sacituzumab Govitecan ensam vid behandling av avancerad urothelial cancer

3 november 2026 uppdaterad av: National Cancer Institute (NCI)

En randomiserad fas III-studie av Pembrolizumab i kombination med Sacituzumab Govitecan vs Sacituzumab Govitecan ensam vid anti-PD(L)1-resistent avancerad urothelial cancer

This phase III trial compares the effectiveness of pembrolizumab and sacituzumab govitecan-hziy to standard of care in treating patients with urothelial cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Sacituzumab govitecan-hziy is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug called govitecan-hziy. Sacituzumab attaches to TROP2 positive tumor cells in a targeted way and delivers govitecan-hziy to kill them. The usual treatment approach is treatment with chemotherapy such as cisplatin, carboplatin, gemcitabine, docetaxel or paclitaxel. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Giving pembrolizumab and sacituzumab govitecan-hziy may be more effective than usual care of carboplatin or cisplatin with gemcitabine, docetaxel or paclitaxel in treating patients with locally advanced or metastatic urothelial cancer.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

PRIMARY OBJECTIVE:

I. To compare overall survival (OS) between the therapy of physician choice (TPC) arm and the Sacituzumab govitecan-hziy + pembrolizumab arm.

SECONDARY OBJECTIVES:

I. To compare the progression free survival (PFS) between the TPC arm and the Sacituzumab govitecan-hziy + pembrolizumab arm.

II. To evaluate overall response rate (ORR) between the TPC arm and the Sacituzumab govitecan-hziy + pembrolizumab arm.

III. To evaluate clinical benefit rate (complete response [CR]/partial response [PR] /stable disease [SD]) between the TPC arm and the Sacituzumab govitecan-hziy + pembrolizumab arm.

IV. To evaluate duration of response (DoR) between the TPC arm and the Sacituzumab govitecan-hziy + pembrolizumab arm.

V. To evaluate toxicity of the Sacituzumab govitecan-hziy + pembrolizumab arm using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).

EXPLORATORY HEALTH RELATED QUALITY OF LIFE (HRQOL) OBJECTIVES:

I. To compare HRQOL, as assessed by the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBISI-18) summary score between patients on the TPC arm versus the Sacituzumab govitecan-hziy + pembrolizumab arm at 6 months.

II. To compare HRQOL change from baseline, as assessed by the FBISI-18 summary score, for patients on the TPC arm versus the Sacituzumab govitecan-hziy + pembrolizumab arm at baseline, 3, 6, and 12 months.

III. To compare the change in patient-reported fatigue from baseline and across 3, 6, and 12 months as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) summary score; change from baseline will be compared between patients on the TPC arm versus the Sacituzumab govitecan-hziy + pembrolizumab arm.

IV. To compare quality-adjusted survival (overall survival x health utility score assessed by the European Quality of Life Five Dimension Five Level [EQ-5D-5L]) between patients on the TPC arm versus the Sacituzumab govitecan-hziy + pembrolizumab arm.

V. To compare time to HRQOL deterioration in global HRQOL, as measured by the FBISI-18 disease-related physical symptom subscale (FBISI-18 disease-related symptoms (DRS) in the physical emotional domains [DRS-P]), between patients on the TPC arm versus the Sacituzumab govitecan-hziy + pembrolizumab arm.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive TPC with carboplatin or cisplatin intravenously (IV) on day 1 and gemcitabine IV on days 1 and 8 of each cycle. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may alternately receive TPC with docetaxel IV on day 1 of each cycle or paclitaxel IV on either day 1 or days 1, 8, and 15 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection and computed tomography (CT) or magnetic resonance imaging (MRI) throughout the study.

ARM B: Patients receive sacituzumab govitecan-hziy IV over 1-3 hours on days 1 and 8 and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 35 cycles or for 2 years of pembrolizumab in the absence of disease progression or unacceptable toxicity. Cycles of sacituzumab govitecan-hziy repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, and CT or MRI throughout the study.

After completion of study treatment, patients are followed up at 30 days then once a year for 5 years from the date of randomization.

Studietyp

Interventionell

Inskrivning (Beräknad)

320

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Arizona
      • Phoenix, Arizona, Förenta staterna, 85004
    • California
      • Irvine, California, Förenta staterna, 92612
        • Rekrytering
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
        • Kontakt:
        • Huvudutredare:
          • Nataliya Mar
      • Orange, California, Förenta staterna, 92868
        • Rekrytering
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Kontakt:
        • Huvudutredare:
          • Nataliya Mar
    • Florida
      • Gainesville, Florida, Förenta staterna, 32610
        • Rekrytering
        • UF Health Cancer Institute - Gainesville
        • Huvudutredare:
          • Daniel V. Araujo
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 352-273-8010
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30322
        • Rekrytering
        • Emory University Hospital/Winship Cancer Institute
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 404-778-1868
        • Huvudutredare:
          • Jacqueline T. Brown
      • Atlanta, Georgia, Förenta staterna, 30308
        • Rekrytering
        • Emory University Hospital Midtown
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 888-946-7447
        • Huvudutredare:
          • Jacqueline T. Brown
      • Atlanta, Georgia, Förenta staterna, 30342
        • Rekrytering
        • Emory Saint Joseph's Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 404-851-7115
        • Huvudutredare:
          • Jacqueline T. Brown
    • Idaho
      • Coeur d'Alene, Idaho, Förenta staterna, 83814
        • Rekrytering
        • Kootenai Health - Coeur d'Alene
        • Huvudutredare:
          • John M. Schallenkamp
        • Kontakt:
      • Post Falls, Idaho, Förenta staterna, 83854
        • Rekrytering
        • Kootenai Clinic Cancer Services - Post Falls
        • Huvudutredare:
          • John M. Schallenkamp
        • Kontakt:
      • Sandpoint, Idaho, Förenta staterna, 83864
        • Rekrytering
        • Kootenai Clinic Cancer Services - Sandpoint
        • Huvudutredare:
          • John M. Schallenkamp
        • Kontakt:
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60612
        • Rekrytering
        • University of Illinois
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 312-355-3046
        • Huvudutredare:
          • Karine Tawagi
      • Danville, Illinois, Förenta staterna, 61832
        • Rekrytering
        • Carle at The Riverfront
        • Huvudutredare:
          • Priyank P. Patel
        • Kontakt:
      • Decatur, Illinois, Förenta staterna, 62526
        • Rekrytering
        • Cancer Care Specialists of Illinois - Decatur
        • Huvudutredare:
          • Bryan A. Faller
        • Kontakt:
      • Decatur, Illinois, Förenta staterna, 62526
        • Rekrytering
        • Decatur Memorial Hospital
        • Huvudutredare:
          • Bryan A. Faller
        • Kontakt:
      • Effingham, Illinois, Förenta staterna, 62401
        • Rekrytering
        • Carle Physician Group-Effingham
        • Kontakt:
        • Huvudutredare:
          • Priyank P. Patel
      • Effingham, Illinois, Förenta staterna, 62401
        • Rekrytering
        • Crossroads Cancer Center
        • Huvudutredare:
          • Bryan A. Faller
        • Kontakt:
      • Mattoon, Illinois, Förenta staterna, 61938
        • Rekrytering
        • Carle Physician Group-Mattoon/Charleston
        • Kontakt:
        • Huvudutredare:
          • Priyank P. Patel
      • Normal, Illinois, Förenta staterna, 61761
        • Rekrytering
        • Carle BroMenn Medical Center
        • Huvudutredare:
          • Priyank P. Patel
        • Kontakt:
      • Normal, Illinois, Förenta staterna, 61761
        • Rekrytering
        • Carle Cancer Institute Normal
        • Huvudutredare:
          • Priyank P. Patel
        • Kontakt:
      • O'Fallon, Illinois, Förenta staterna, 62269
        • Rekrytering
        • Cancer Care Center of O'Fallon
        • Huvudutredare:
          • Bryan A. Faller
        • Kontakt:
      • O'Fallon, Illinois, Förenta staterna, 62269
        • Rekrytering
        • HSHS Saint Elizabeth's Hospital
        • Huvudutredare:
          • Bryan A. Faller
        • Kontakt:
      • Shiloh, Illinois, Förenta staterna, 62269
        • Rekrytering
        • Memorial Hospital East
        • Kontakt:
        • Huvudutredare:
          • Melissa A. Reimers
      • Springfield, Illinois, Förenta staterna, 62702
        • Rekrytering
        • Southern Illinois University School of Medicine
        • Huvudutredare:
          • Bryan A. Faller
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 217-545-7929
      • Springfield, Illinois, Förenta staterna, 62702
        • Rekrytering
        • Springfield Clinic
        • Huvudutredare:
          • Bryan A. Faller
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 800-444-7541
      • Springfield, Illinois, Förenta staterna, 62781
        • Rekrytering
        • Springfield Memorial Hospital
        • Huvudutredare:
          • Bryan A. Faller
        • Kontakt:
      • Urbana, Illinois, Förenta staterna, 61801
        • Rekrytering
        • Carle Cancer Center
        • Kontakt:
        • Huvudutredare:
          • Priyank P. Patel
    • Iowa
      • Ames, Iowa, Förenta staterna, 50010
        • Rekrytering
        • Mary Greeley Medical Center
        • Huvudutredare:
          • Joseph J. Merchant
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 515-956-4132
      • Ames, Iowa, Förenta staterna, 50010
        • Rekrytering
        • McFarland Clinic - Ames
        • Huvudutredare:
          • Joseph J. Merchant
        • Kontakt:
      • Boone, Iowa, Förenta staterna, 50036
        • Upphängd
        • McFarland Clinic - Boone
      • Cedar Rapids, Iowa, Förenta staterna, 52403
        • Rekrytering
        • Mercy Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 319-365-4673
        • Huvudutredare:
          • Deborah W. Wilbur
      • Cedar Rapids, Iowa, Förenta staterna, 52403
        • Rekrytering
        • Oncology Associates at Mercy Medical Center
        • Huvudutredare:
          • Deborah W. Wilbur
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 319-363-2690
      • Fort Dodge, Iowa, Förenta staterna, 50501
        • Rekrytering
        • McFarland Clinic - Trinity Cancer Center
        • Huvudutredare:
          • Joseph J. Merchant
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 515-956-4132
      • Jefferson, Iowa, Förenta staterna, 50129
        • Upphängd
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, Förenta staterna, 50158
        • Rekrytering
        • McFarland Clinic - Marshalltown
        • Huvudutredare:
          • Joseph J. Merchant
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 515-956-4132
    • Kansas
      • Hays, Kansas, Förenta staterna, 67601
        • Rekrytering
        • HaysMed
        • Huvudutredare:
          • Saqib Abbasi
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 785-623-5774
      • Kansas City, Kansas, Förenta staterna, 66160
        • Rekrytering
        • University of Kansas Cancer Center
        • Huvudutredare:
          • Saqib Abbasi
        • Kontakt:
      • Lawrence, Kansas, Förenta staterna, 66044
        • Rekrytering
        • Lawrence Memorial Hospital
        • Huvudutredare:
          • Saqib Abbasi
        • Kontakt:
      • Olathe, Kansas, Förenta staterna, 66061
        • Rekrytering
        • The University of Kansas Cancer Center - Olathe
        • Huvudutredare:
          • Saqib Abbasi
        • Kontakt:
      • Overland Park, Kansas, Förenta staterna, 66210
        • Rekrytering
        • University of Kansas Cancer Center-Overland Park
        • Huvudutredare:
          • Saqib Abbasi
        • Kontakt:
      • Salina, Kansas, Förenta staterna, 67401
        • Rekrytering
        • Salina Regional Health Center
        • Huvudutredare:
          • Saqib Abbasi
        • Kontakt:
      • Topeka, Kansas, Förenta staterna, 66606
        • Rekrytering
        • University of Kansas Health System Saint Francis Campus
        • Huvudutredare:
          • Saqib Abbasi
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 785-295-8000
      • Westwood, Kansas, Förenta staterna, 66205
        • Rekrytering
        • University of Kansas Hospital-Westwood Cancer Center
        • Huvudutredare:
          • Saqib Abbasi
        • Kontakt:
    • Kentucky
      • Louisville, Kentucky, Förenta staterna, 40202
        • Rekrytering
        • The James Graham Brown Cancer Center at University of Louisville
        • Huvudutredare:
          • Rohit Kumar
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 502-562-3429
      • Louisville, Kentucky, Förenta staterna, 40245
        • Rekrytering
        • UofL Health Medical Center Northeast
        • Huvudutredare:
          • Rohit Kumar
        • Kontakt:
    • Louisiana
      • Baton Rouge, Louisiana, Förenta staterna, 70809
        • Rekrytering
        • Louisiana Hematology Oncology Associates LLC
        • Kontakt:
        • Huvudutredare:
          • Scott E. Delacroix
      • Metairie, Louisiana, Förenta staterna, 70002
        • Rekrytering
        • Mary Bird Perkins Cancer Center - Metairie
        • Huvudutredare:
          • Scott E. Delacroix
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 504-584-6990
    • Massachusetts
      • Worcester, Massachusetts, Förenta staterna, 01655
        • Rekrytering
        • UMass Memorial Medical Center - University Campus
        • Kontakt:
        • Huvudutredare:
          • Kriti Mittal
    • Michigan
      • Brighton, Michigan, Förenta staterna, 48114
        • Rekrytering
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Kontakt:
        • Huvudutredare:
          • Houssam Y. Hariri
      • Canton, Michigan, Förenta staterna, 48188
        • Rekrytering
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Kontakt:
        • Huvudutredare:
          • Houssam Y. Hariri
      • Chelsea, Michigan, Förenta staterna, 48118
        • Rekrytering
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Kontakt:
        • Huvudutredare:
          • Houssam Y. Hariri
      • Lansing, Michigan, Förenta staterna, 48912
        • Rekrytering
        • University of Michigan Health - Sparrow Lansing
        • Kontakt:
        • Huvudutredare:
          • Houssam Y. Hariri
      • Livonia, Michigan, Förenta staterna, 48154
        • Rekrytering
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Kontakt:
        • Huvudutredare:
          • Houssam Y. Hariri
      • Pontiac, Michigan, Förenta staterna, 48341
        • Rekrytering
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Kontakt:
        • Huvudutredare:
          • Houssam Y. Hariri
      • Ypsilanti, Michigan, Förenta staterna, 48197
        • Rekrytering
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Kontakt:
        • Huvudutredare:
          • Houssam Y. Hariri
    • Minnesota
      • Brainerd, Minnesota, Förenta staterna, 56401
        • Rekrytering
        • Essentia Health Saint Joseph's Medical Center
        • Kontakt:
        • Huvudutredare:
          • Bret E. Friday
      • Coon Rapids, Minnesota, Förenta staterna, 55433
        • Rekrytering
        • Mercy Hospital
        • Kontakt:
        • Huvudutredare:
          • David M. King
      • Deer River, Minnesota, Förenta staterna, 56636
        • Rekrytering
        • Essentia Health - Deer River Clinic
        • Kontakt:
        • Huvudutredare:
          • Bret E. Friday
      • Duluth, Minnesota, Förenta staterna, 55805
        • Rekrytering
        • Essentia Health Cancer Center
        • Kontakt:
        • Huvudutredare:
          • Bret E. Friday
      • Edina, Minnesota, Förenta staterna, 55435
        • Rekrytering
        • Fairview Southdale Hospital
        • Kontakt:
        • Huvudutredare:
          • David M. King
      • Edina, Minnesota, Förenta staterna, 55435
        • Rekrytering
        • Minnesota Oncology - Edina
        • Kontakt:
        • Huvudutredare:
          • David M. King
      • Hibbing, Minnesota, Förenta staterna, 55746
        • Rekrytering
        • Essentia Health Hibbing Clinic
        • Huvudutredare:
          • Bret E. Friday
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 218-786-3308
      • Marshall, Minnesota, Förenta staterna, 56258
        • Rekrytering
        • Avera Cancer Institute at Marshall
        • Kontakt:
        • Huvudutredare:
          • Ryan A. Vaca
      • Minneapolis, Minnesota, Förenta staterna, 55407
        • Rekrytering
        • Abbott-Northwestern Hospital
        • Kontakt:
        • Huvudutredare:
          • David M. King
      • Saint Louis Park, Minnesota, Förenta staterna, 55416
        • Rekrytering
        • Park Nicollet Clinic - Saint Louis Park
        • Kontakt:
        • Huvudutredare:
          • David M. King
      • Saint Paul, Minnesota, Förenta staterna, 55101
        • Rekrytering
        • Regions Hospital
        • Kontakt:
        • Huvudutredare:
          • David M. King
      • Saint Paul, Minnesota, Förenta staterna, 55102
        • Rekrytering
        • United Hospital
        • Kontakt:
        • Huvudutredare:
          • David M. King
      • Sandstone, Minnesota, Förenta staterna, 55072
        • Rekrytering
        • Essentia Health Sandstone
        • Kontakt:
        • Huvudutredare:
          • Bret E. Friday
      • Virginia, Minnesota, Förenta staterna, 55792
        • Rekrytering
        • Essentia Health Virginia Clinic
        • Kontakt:
        • Huvudutredare:
          • Bret E. Friday
    • Missouri
      • Cape Girardeau, Missouri, Förenta staterna, 63703
        • Rekrytering
        • Saint Francis Medical Center
        • Huvudutredare:
          • Bryan A. Faller
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 573-334-2230
          • E-post: sfmc@sfmc.net
      • City of Saint Peters, Missouri, Förenta staterna, 63376
        • Rekrytering
        • Siteman Cancer Center at Saint Peters Hospital
        • Kontakt:
        • Huvudutredare:
          • Melissa A. Reimers
      • Creve Coeur, Missouri, Förenta staterna, 63141
        • Rekrytering
        • Siteman Cancer Center at West County Hospital
        • Kontakt:
        • Huvudutredare:
          • Melissa A. Reimers
      • Farmington, Missouri, Förenta staterna, 63640
        • Rekrytering
        • Parkland Health Center - Farmington
        • Huvudutredare:
          • Bryan A. Faller
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 314-996-5569
      • Kansas City, Missouri, Förenta staterna, 64154
        • Rekrytering
        • University of Kansas Cancer Center - North
        • Huvudutredare:
          • Saqib Abbasi
        • Kontakt:
      • Kansas City, Missouri, Förenta staterna, 64108
        • Rekrytering
        • University Health Truman Medical Center
        • Huvudutredare:
          • Saqib Abbasi
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 816-404-4375
      • Kansas City, Missouri, Förenta staterna, 64116
        • Rekrytering
        • University of Kansas Cancer Center - Briarcliff
        • Huvudutredare:
          • Saqib Abbasi
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 913-588-3671
      • Lee's Summit, Missouri, Förenta staterna, 64064
        • Rekrytering
        • University of Kansas Cancer Center - Lee's Summit
        • Huvudutredare:
          • Saqib Abbasi
        • Kontakt:
      • Sainte Genevieve, Missouri, Förenta staterna, 63670
        • Rekrytering
        • Sainte Genevieve County Memorial Hospital
        • Huvudutredare:
          • Bryan A. Faller
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 314-996-5569
      • St Louis, Missouri, Förenta staterna, 63110
        • Rekrytering
        • Washington University School of Medicine
        • Kontakt:
        • Huvudutredare:
          • Melissa A. Reimers
      • St Louis, Missouri, Förenta staterna, 63129
        • Rekrytering
        • Siteman Cancer Center-South County
        • Kontakt:
        • Huvudutredare:
          • Melissa A. Reimers
      • St Louis, Missouri, Förenta staterna, 63136
        • Rekrytering
        • Siteman Cancer Center at Christian Hospital
        • Kontakt:
        • Huvudutredare:
          • Melissa A. Reimers
      • St Louis, Missouri, Förenta staterna, 63131
        • Rekrytering
        • Missouri Baptist Medical Center
        • Huvudutredare:
          • Bryan A. Faller
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 314-996-5569
      • Sullivan, Missouri, Förenta staterna, 63080
        • Rekrytering
        • Missouri Baptist Sullivan Hospital
        • Huvudutredare:
          • Bryan A. Faller
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 314-996-5569
    • Montana
      • Anaconda, Montana, Förenta staterna, 59711
        • Rekrytering
        • Community Hospital of Anaconda
        • Huvudutredare:
          • John M. Schallenkamp
        • Kontakt:
      • Billings, Montana, Förenta staterna, 59101
        • Rekrytering
        • Billings Clinic Cancer Center
        • Huvudutredare:
          • John M. Schallenkamp
        • Kontakt:
      • Bozeman, Montana, Förenta staterna, 59715
        • Rekrytering
        • Bozeman Health Deaconess Hospital
        • Huvudutredare:
          • John M. Schallenkamp
        • Kontakt:
      • Great Falls, Montana, Förenta staterna, 59405
        • Rekrytering
        • Benefis Sletten Cancer Institute
        • Huvudutredare:
          • John M. Schallenkamp
        • Kontakt:
      • Kalispell, Montana, Förenta staterna, 59901
        • Rekrytering
        • Logan Health Medical Center
        • Huvudutredare:
          • John M. Schallenkamp
        • Kontakt:
      • Missoula, Montana, Förenta staterna, 59804
        • Rekrytering
        • Community Medical Center
        • Huvudutredare:
          • John M. Schallenkamp
        • Kontakt:
    • New Hampshire
      • Lebanon, New Hampshire, Förenta staterna, 03756
        • Rekrytering
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Kontakt:
        • Huvudutredare:
          • Jacob B. Reibel
    • New Jersey
      • Livingston, New Jersey, Förenta staterna, 07039
        • Rekrytering
        • Cooperman Barnabas Medical Center
        • Huvudutredare:
          • Biren Saraiya
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 973-322-5200
      • Long Branch, New Jersey, Förenta staterna, 07740
        • Rekrytering
        • Monmouth Medical Center
        • Kontakt:
        • Huvudutredare:
          • Biren Saraiya
      • New Brunswick, New Jersey, Förenta staterna, 08903
        • Rekrytering
        • Rutgers Cancer Institute of New Jersey
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 732-235-7356
        • Huvudutredare:
          • Biren Saraiya
      • Newark, New Jersey, Förenta staterna, 07101
        • Rekrytering
        • Rutgers New Jersey Medical School
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 732-235-7356
        • Huvudutredare:
          • Biren Saraiya
      • Somerville, New Jersey, Förenta staterna, 08876
        • Rekrytering
        • Robert Wood Johnson University Hospital Somerset
        • Huvudutredare:
          • Biren Saraiya
        • Kontakt:
      • Toms River, New Jersey, Förenta staterna, 08755
        • Rekrytering
        • Community Medical Center
        • Huvudutredare:
          • Biren Saraiya
        • Kontakt:
    • New York
      • Buffalo, New York, Förenta staterna, 14263
        • Rekrytering
        • Roswell Park Cancer Institute
        • Kontakt:
        • Huvudutredare:
          • Ellis G. Levine
      • Stony Brook, New York, Förenta staterna, 11794
        • Rekrytering
        • Stony Brook University Medical Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 800-862-2215
        • Huvudutredare:
          • Judy Huang
      • Williamsville, New York, Förenta staterna, 14221
        • Rekrytering
        • Roswell Park Amherst Center
        • Kontakt:
        • Huvudutredare:
          • Ellis G. Levine
    • North Carolina
      • Hendersonville, North Carolina, Förenta staterna, 28791
    • North Dakota
      • Fargo, North Dakota, Förenta staterna, 58103
        • Rekrytering
        • Essentia Health Cancer Center-South University Clinic
        • Kontakt:
        • Huvudutredare:
          • Bret E. Friday
    • Ohio
      • Columbus, Ohio, Förenta staterna, 43210
        • Rekrytering
        • Ohio State University Comprehensive Cancer Center
        • Kontakt:
        • Huvudutredare:
          • Yuanquan Yang
    • Oklahoma
      • Oklahoma City, Oklahoma, Förenta staterna, 73104
        • Rekrytering
        • University of Oklahoma Health Sciences Center
        • Kontakt:
        • Huvudutredare:
          • Adanma Anji Ayanambakkam Attanathi
    • Pennsylvania
      • Danville, Pennsylvania, Förenta staterna, 17822
        • Rekrytering
        • Geisinger Medical Center
        • Huvudutredare:
          • Sorab Gupta
        • Kontakt:
      • Dickson City, Pennsylvania, Förenta staterna, 18519
        • Rekrytering
        • Geisinger Cancer Center Dickson City
        • Huvudutredare:
          • Sorab Gupta
        • Kontakt:
      • Erie, Pennsylvania, Förenta staterna, 16505
        • Rekrytering
        • UPMC Hillman Cancer Center Erie
        • Huvudutredare:
          • Leonard J. Appleman
        • Kontakt:
      • Erie, Pennsylvania, Förenta staterna, 16544
        • Rekrytering
        • Saint Vincent Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 814-452-5000
        • Huvudutredare:
          • Alexander Helfand
      • Greensburg, Pennsylvania, Förenta staterna, 15601
        • Rekrytering
        • UPMC Cancer Centers - Arnold Palmer Pavilion
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 724-838-1900
        • Huvudutredare:
          • Leonard J. Appleman
      • Harrisburg, Pennsylvania, Förenta staterna, 17109
        • Rekrytering
        • UPMC Pinnacle Cancer Center/Community Osteopathic Campus
        • Kontakt:
        • Huvudutredare:
          • Leonard J. Appleman
      • Hershey, Pennsylvania, Förenta staterna, 17033-0850
        • Rekrytering
        • Penn State Milton S Hershey Medical Center
        • Kontakt:
        • Huvudutredare:
          • Monika Joshi
      • Indiana, Pennsylvania, Förenta staterna, 15701
        • Rekrytering
        • IRMC Cancer Center
        • Kontakt:
        • Huvudutredare:
          • Leonard J. Appleman
      • Jefferson Hills, Pennsylvania, Förenta staterna, 15025
        • Rekrytering
        • Jefferson Hospital
        • Kontakt:
        • Huvudutredare:
          • Alexander Helfand
      • Lewisburg, Pennsylvania, Förenta staterna, 17837
        • Rekrytering
        • Geisinger Medical Oncology-Lewisburg
        • Huvudutredare:
          • Sorab Gupta
        • Kontakt:
      • Mechanicsburg, Pennsylvania, Förenta staterna, 17050
        • Rekrytering
        • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
        • Kontakt:
        • Huvudutredare:
          • Leonard J. Appleman
      • Monroeville, Pennsylvania, Förenta staterna, 15146
        • Rekrytering
        • Forbes Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 412-858-7746
        • Huvudutredare:
          • Alexander Helfand
      • Monroeville, Pennsylvania, Förenta staterna, 15146
        • Rekrytering
        • UPMC Hillman Cancer Center - Monroeville
        • Huvudutredare:
          • Leonard J. Appleman
        • Kontakt:
      • Natrona Heights, Pennsylvania, Förenta staterna, 15065
        • Rekrytering
        • Allegheny Valley Hospital
        • Kontakt:
        • Huvudutredare:
          • Alexander Helfand
      • Pittsburgh, Pennsylvania, Förenta staterna, 15224
        • Rekrytering
        • West Penn Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 412-578-5000
        • Huvudutredare:
          • Alexander Helfand
      • Pittsburgh, Pennsylvania, Förenta staterna, 15215
        • Rekrytering
        • UPMC-Saint Margaret
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 412-784-4900
        • Huvudutredare:
          • Leonard J. Appleman
      • Pittsburgh, Pennsylvania, Förenta staterna, 15237
        • Rekrytering
        • UPMC-Passavant Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 412-367-6454
        • Huvudutredare:
          • Leonard J. Appleman
      • Pittsburgh, Pennsylvania, Förenta staterna, 15212
        • Rekrytering
        • Allegheny General Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 877-284-2000
        • Huvudutredare:
          • Alexander Helfand
      • Pittsburgh, Pennsylvania, Förenta staterna, 15232
        • Rekrytering
        • UPMC Hillman Cancer Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 412-647-8073
        • Huvudutredare:
          • Leonard J. Appleman
      • Seneca, Pennsylvania, Förenta staterna, 16346
        • Rekrytering
        • UPMC Cancer Center at UPMC Northwest
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 814-676-7900
        • Huvudutredare:
          • Leonard J. Appleman
      • Uniontown, Pennsylvania, Förenta staterna, 15401
        • Rekrytering
        • UPMC Cancer Center-Uniontown
        • Kontakt:
        • Huvudutredare:
          • Leonard J. Appleman
      • Washington, Pennsylvania, Förenta staterna, 15301
        • Rekrytering
        • UPMC Cancer Center-Washington
        • Kontakt:
        • Huvudutredare:
          • Leonard J. Appleman
      • West Reading, Pennsylvania, Förenta staterna, 19611
        • Rekrytering
        • Reading Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 610-988-9323
        • Huvudutredare:
          • Terrence P. Cescon
      • Wexford, Pennsylvania, Förenta staterna, 15090
        • Rekrytering
        • Wexford Health and Wellness Pavilion
        • Kontakt:
        • Huvudutredare:
          • Alexander Helfand
      • Wilkes-Barre, Pennsylvania, Förenta staterna, 18711
        • Rekrytering
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Kontakt:
        • Huvudutredare:
          • Sorab Gupta
    • South Dakota
      • Aberdeen, South Dakota, Förenta staterna, 57401
        • Rekrytering
        • Avera Cancer Institute-Aberdeen
        • Kontakt:
        • Huvudutredare:
          • Ryan A. Vaca
      • Mitchell, South Dakota, Förenta staterna, 57301
        • Rekrytering
        • Avera Cancer Institute - Mitchell
        • Kontakt:
        • Huvudutredare:
          • Ryan A. Vaca
      • Pierre, South Dakota, Förenta staterna, 57501
        • Rekrytering
        • Avera Cancer Institute at Pierre
        • Kontakt:
        • Huvudutredare:
          • Ryan A. Vaca
      • Sioux Falls, South Dakota, Förenta staterna, 57105
        • Rekrytering
        • Avera Cancer Institute
        • Kontakt:
        • Huvudutredare:
          • Ryan A. Vaca
      • Yankton, South Dakota, Förenta staterna, 57078
        • Rekrytering
        • Avera Cancer Institute at Yankton
        • Huvudutredare:
          • Ryan A. Vaca
        • Kontakt:
    • Texas
      • Baytown, Texas, Förenta staterna, 77521
        • Rekrytering
        • Houston Methodist San Jacinto Hospital
        • Kontakt:
        • Huvudutredare:
          • Patrick E. Prath
      • Cypress, Texas, Förenta staterna, 77429
        • Rekrytering
        • Houston Methodist Cypress Hospital
        • Kontakt:
        • Huvudutredare:
          • Patrick E. Prath
      • Dallas, Texas, Förenta staterna, 75390
        • Rekrytering
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Kontakt:
        • Huvudutredare:
          • Suzanne M. Cole
      • Dallas, Texas, Förenta staterna, 75235
      • Dallas, Texas, Förenta staterna, 75237
        • Rekrytering
        • UT Southwestern Simmons Cancer Center - RedBird
        • Huvudutredare:
          • Suzanne M. Cole
        • Kontakt:
      • Fort Worth, Texas, Förenta staterna, 76104
        • Rekrytering
        • UT Southwestern/Simmons Cancer Center-Fort Worth
        • Kontakt:
        • Huvudutredare:
          • Suzanne M. Cole
      • Houston, Texas, Förenta staterna, 77030
        • Rekrytering
        • Houston Methodist Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 713-790-2700
        • Huvudutredare:
          • Patrick E. Prath
      • Houston, Texas, Förenta staterna, 77070
        • Rekrytering
        • Methodist Willowbrook Hospital
        • Kontakt:
        • Huvudutredare:
          • Patrick E. Prath
      • Houston, Texas, Förenta staterna, 77094
        • Rekrytering
        • Houston Methodist West Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 832-522-2873
        • Huvudutredare:
          • Patrick E. Prath
      • Nassau Bay, Texas, Förenta staterna, 77058
        • Rekrytering
        • Houston Methodist Saint John Hospital
        • Kontakt:
        • Huvudutredare:
          • Patrick E. Prath
      • Richardson, Texas, Förenta staterna, 75080
        • Rekrytering
        • UT Southwestern Clinical Center at Richardson/Plano
        • Kontakt:
        • Huvudutredare:
          • Suzanne M. Cole
      • Sugar Land, Texas, Förenta staterna, 77479
        • Rekrytering
        • Houston Methodist Sugar Land Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 281-242-2873
        • Huvudutredare:
          • Patrick E. Prath
      • The Woodlands, Texas, Förenta staterna, 77385
        • Rekrytering
        • Houston Methodist The Woodlands Hospital
        • Kontakt:
        • Huvudutredare:
          • Patrick E. Prath
    • Vermont
      • Berlin Corners, Vermont, Förenta staterna, 05602
        • Rekrytering
        • Central Vermont Medical Center/National Life Cancer Treatment
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 802-225-5400
        • Huvudutredare:
          • Rahul Anil
      • Burlington, Vermont, Förenta staterna, 05401
        • Rekrytering
        • University of Vermont Medical Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 802-656-4101
          • E-post: rpo@uvm.edu
        • Huvudutredare:
          • Rahul Anil
      • Burlington, Vermont, Förenta staterna, 05405
        • Rekrytering
        • University of Vermont and State Agricultural College
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 802-656-8990
          • E-post: rpo@uvm.edu
        • Huvudutredare:
          • Rahul Anil
      • Saint Johnsbury, Vermont, Förenta staterna, 05819
        • Rekrytering
        • Dartmouth Cancer Center - North
        • Kontakt:
        • Huvudutredare:
          • Jacob B. Reibel
    • Virginia
      • Fredericksburg, Virginia, Förenta staterna, 22408
        • Rekrytering
        • Hematology Oncology Associates of Fredericksburg Inc
        • Kontakt:
        • Huvudutredare:
          • Asit K. Paul
      • Richmond, Virginia, Förenta staterna, 23229
        • Rekrytering
        • Virginia Cancer Institute
        • Kontakt:
        • Huvudutredare:
          • Asit K. Paul
      • Richmond, Virginia, Förenta staterna, 23235
        • Rekrytering
        • VCU Massey Cancer Center at Stony Point
        • Kontakt:
        • Huvudutredare:
          • Asit K. Paul
      • Richmond, Virginia, Förenta staterna, 23298
        • Rekrytering
        • VCU Massey Comprehensive Cancer Center
        • Huvudutredare:
          • Asit K. Paul
        • Kontakt:
    • Washington
      • Bellevue, Washington, Förenta staterna, 98004
        • Rekrytering
        • FHCC Overlake
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 425-454-2148
        • Huvudutredare:
          • Mikhail G. Perlov
      • Kirkland, Washington, Förenta staterna, 98034
        • Rekrytering
        • FHCC at EvergreenHealth
        • Huvudutredare:
          • Prakash Varadarajan
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 425-899-6000
      • Seattle, Washington, Förenta staterna, 98195
        • Rekrytering
        • University of Washington Medical Center - Montlake
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 800-804-8824
        • Huvudutredare:
          • Petros Grivas
      • Seattle, Washington, Förenta staterna, 98109
        • Rekrytering
        • Fred Hutchinson Cancer Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 800-804-8824
        • Huvudutredare:
          • Petros Grivas
      • Seattle, Washington, Förenta staterna, 98133
        • Rekrytering
        • FHCC at Northwest Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 206-606-5800
        • Huvudutredare:
          • Nellowe Candelario
    • West Virginia
      • Charleston, West Virginia, Förenta staterna, 25304
        • Rekrytering
        • Vandalia Health/CAMC Institute for Academic Medicine
        • Huvudutredare:
          • Kok Hoe Chan
        • Kontakt:
    • Wisconsin
      • Appleton, Wisconsin, Förenta staterna, 54911
        • Rekrytering
        • ThedaCare Regional Cancer Center
        • Kontakt:
        • Huvudutredare:
          • Joyce Philip
      • Ashland, Wisconsin, Förenta staterna, 54806
        • Rekrytering
        • Duluth Clinic Ashland
        • Kontakt:
        • Huvudutredare:
          • Bret E. Friday
      • La Crosse, Wisconsin, Förenta staterna, 54601
        • Rekrytering
        • Gundersen Lutheran Medical Center
        • Kontakt:
        • Huvudutredare:
          • Kurt Oettel
      • New Richmond, Wisconsin, Förenta staterna, 54017
        • Rekrytering
        • Cancer Center of Western Wisconsin
        • Kontakt:
        • Huvudutredare:
          • David M. King

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Patient must be ≥ 18 years of age

  • Patient must have Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

  • Patient must have locally advanced (unresectable and/or not amenable to curative intent therapy) or metastatic urothelial cancer

  • Patient must have histologically (or based on urine cytology) proven conventional urothelial carcinoma (UC) of any urinary tract origin [any histologic subtype except neuroendocrine (small or large cell)] are permitted so long as tumors include ≥ 1% conventional urothelial histology). NOTE: Pure non-urothelial histology is excluded

  • Patient must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Baseline imaging must be obtained ≤ 35 days prior to randomization

  • Patient must have the following prior treatment(s). Patient must have had progression on or after the immediate prior anti-cancer therapy

  • Patient must have had prior exposure to anti-PD(L)1 therapy [anti -PD(L)1 monotherapy or as a combination regimen in any disease/therapy setting for UC]. Patients must have received at least 1 dose of anti-PD(L)1 therapy

    • NOTE: Anti-PD(L)1 therapy does not need to be the most recent therapy received prior to enrollment on this protocol
    • NOTE: Patient must not have had progression within 12 weeks of starting their first anti-PD(L) 1 therapy, even if anti-PD-(L)1 treatment was given in more than one lines of therapy

  • Patient must have had ≥ 1 line of systemic therapy given in the advanced/metastatic disease setting, except for patients who had received anti-PD(L)1 + enfortumab vedotin in the localized disease setting (e.g., neoadjuvant and/or adjuvant) and had cancer progression within 12 months from the last systemic therapy dose

  • For tumors with known FGFR3+ susceptible alteration (for FGFR inhibitor), patients must have received a prior FGFR inhibitor unless contraindicated per physician discretion

  • Patient must have received prior enfortumab vedotin or any other Nectin-4 directed therapy or other MMAE-containing therapy in any disease/therapy setting unless contraindicated per physician

  • Patient must have had no prior exposure to Sacituzumab govitecan-hziy or other TROP-2 directed therapies or antibody-drug conjugate that contains topo-isomerase I inhibitor, e.g. trastuzumab deruxtecan

  • Patient must have Bellmunt score of 0-2. The Bellmunt score assesses a patient's risk and is calculated based on ECOG PS, hemoglobin level and presence of liver metastases

  • Patient must not have history of grade 3-4 immune-related adverse events on prior anti-PD1/L1, except for endocrinopathies on adequate hormone therapy repletion and/or clinically insignificant laboratory abnormalities

  • Patient must have recovered (i.e., ≤ grade 1) from clinically significant AEs due to previously administered systemic therapy agent, except for endocrinopathies on adequate hormone therapy repletion

    • NOTE: Patients with ≤ grade 2 neuropathy, any grade of alopecia, or any grade of non-clinically significant laboratory abnormality are exceptions to this criterion and are allowed in this trial.

    • Examples of non-clinically significant laboratory abnormalities include, but are not limited to:

      • Lymphopenia or monopenia
      • Lymphocytosis or monocytosis
      • Increase in amylase or lipase with no clinical correlation
      • Any other abnormal laboratory findings that have no clinical relevance per the treating investigator.

    • NOTE: If patient has undergone major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to randomization

  • Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization 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 3) 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). Patient must not nurse infants while on protocol treatment and for 4 months after the last dose of protocol treatment

  • Patient must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Patients of childbearing potential must continue contraceptive method(s) or abstain for 6 months after the last dose of protocol treatment. Patients with partners who could become pregnant should use effective contraception during therapy and for 3 months after the last dose of protocol treatment

  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible

  • Absolute neutrophil count (ANC) ≥ 1,500/uL (obtained ≤ 14 days prior to randomization)

  • Platelets ≥ 100,000/uL (obtained ≤ 14 days prior to randomization)

  • Albumin ≥ 3 g/dL (obtained ≤ 14 days prior to randomization)

  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained ≤ 14 days prior to randomization)

  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) ≤ 3 × institutional ULN or ≤ 5.0 x institutional ULN if known liver metastases (obtained ≤ 14 days prior to randomization)

  • Creatinine clearance (CrCl) ≥ 30 mL/min (obtained ≤ 14 days prior to randomization) NOTE: CrCl is estimated using the Cockcroft-Gault formula (or can be measured by 24-hour urine collection if needed)

  • Hemoglobin (Hb) ≥ 8.5 g/dl (obtained ≤ 14 days prior to randomization)

  • Patient must not have a known genetic UGT1A1 *28/*28 or *6/*6 homozygous variant genotype. Patients with homozygous variant types are considered poor metabolizers and are at higher risk for severe adverse events when compared to wild-type. Patients with heterozygous UGT1A1 variants (i.e. *1/*28 or *1/*6) are eligible and should be counseled accordingly and be very closely monitored if randomized to the sacituzumab govitecan arm

    • NOTE: If a patient's UGT1A1 status is unknown, they are eligible to enroll (the study does not require this test as part of screening)

  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible

  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

  • Patients with history of hepatitis C virus (HCV) infection must have been treated and considered cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

  • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and are not using steroids > 10 mg of prednisone (or equivalent) daily for brain metastases for at least 7 days prior to randomization

  • Patients with prior or concurrent malignancy that is not considered clinically significant and whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen (at the discretion of the treating physician) are eligible

  • Patient must not be on systemic immunosuppressive medication, including steroids (if doses exceed the equivalent of prednisone 10 mg daily). Short courses of steroids, e.g. "burst", which are discontinued prior to randomization are acceptable. Patients on inhaled, intranasal, intra-articular and/or topical steroids are eligible

  • Patient must be English or Spanish speaking to be eligible for the HRQOL component of the study.

    • NOTE: Sites cannot translate the associated HRQOL forms

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Arm I (TPC chemotherapy)

Patients receive TPC with carboplatin or cisplatin IV on day 1 and gemcitabine IV on days 1 and 8 of each cycle. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may alternately receive TPC with docetaxel IV on day 1 of each cycle or paclitaxel IV on either day 1 or days 1, 8, and 15 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection and CT or MRI throughout the study.
Läkemedel: Carboplatin

Given IV

Andra namn:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Karboplatina
  • Karbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatina
  • Paraplatin
  • Paraplatin AQ
  • Platinwas
  • Ribocarbo
  • JM8
Läkemedel: Paclitaxel

Given IV

Andra namn:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Läkemedel: Cisplatin

Given IV

Andra namn:
  • CDDP
  • Cis-diammindikloridoplatina
  • Cismaplat
  • Cisplatina
  • Neoplatin
  • Platinol
  • Abiplatin
  • Blastolem
  • Briplatin
  • Cis-diammin-diklorplatina
  • Cis-diamindiklor Platina (II)
  • Cis-diamindiklorplatina
  • Cis-dikloramin Platina (II)
  • Cis-platinös diamindiklorid
  • Cis-platina
  • Cis-platina II
  • Cis-platina II diamindiklorid
  • 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
Läkemedel: Docetaxel

Given IV

Andra namn:
  • Taxotere
  • Docecad
  • RP56976
  • Taxotere injektionskoncentrat
  • RP 56976
  • RP-56976
Procedur: Biospecimen Collection

Undergo blood sample collection

Andra namn:
  • Biologisk provsamling
  • Bioprov insamlat
  • Provsamling
  • Provuppsamling
Procedur: Computed Tomography

Undergo CT

Andra namn:
  • CT
  • KATT
  • Datortomografi
  • Beräknad axiell tomografi
  • Datoriserad axialtomografi
  • tomografi
  • Datoriserad axiell tomografi (förfarande)
  • Datortomografi (CT) skanning
  • Diagnostisk kattskanning
  • Diagnostisk kattskanningstjänsttyp
Procedur: Magnetic Resonance Imaging

Undergo MRI

Andra namn:
  • MRI
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medicinsk bildbehandling, magnetisk resonans / kärnmagnetisk resonans
  • HERR
  • MR-avbildning
  • MRI-skanning
  • NMR-avbildning
  • NMRI
  • Kärnmagnetisk resonanstomografi
  • Magnetisk resonanstomografi (MRT)
  • sMRI
  • Magnetisk resonanstomografi (förfarande)
  • Strukturell MRI
Övrig: Questionnaire Administration

Ancillary studies

Läkemedel: Gemcitabine

Given IV

Andra namn:
  • dFdCyd
  • dFdC
  • Difluordeoxycytidin
Experimentell: Arm II (pembrolizumab, sacituzumab govitecan-hziy)

Patients receive pembrolizumab IV over 30 minutes on day 1 and sacituzumab govitecan-hziy IV over 1-3 hours on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, and CT or MRI throughout the study.
Procedur: Biospecimen Collection

Undergo blood sample collection

Andra namn:
  • Biologisk provsamling
  • Bioprov insamlat
  • Provsamling
  • Provuppsamling
Procedur: Computed Tomography

Undergo CT

Andra namn:
  • CT
  • KATT
  • Datortomografi
  • Beräknad axiell tomografi
  • Datoriserad axialtomografi
  • tomografi
  • Datoriserad axiell tomografi (förfarande)
  • Datortomografi (CT) skanning
  • Diagnostisk kattskanning
  • Diagnostisk kattskanningstjänsttyp
Procedur: Magnetic Resonance Imaging

Undergo MRI

Andra namn:
  • MRI
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medicinsk bildbehandling, magnetisk resonans / kärnmagnetisk resonans
  • HERR
  • MR-avbildning
  • MRI-skanning
  • NMR-avbildning
  • NMRI
  • Kärnmagnetisk resonanstomografi
  • Magnetisk resonanstomografi (MRT)
  • sMRI
  • Magnetisk resonanstomografi (förfarande)
  • Strukturell MRI
Övrig: Questionnaire Administration

Ancillary studies

Biologisk: Pembrolizumab

Given IV

Andra namn:
  • Keytruda
  • MK-3475
  • Lambrolizumab
  • SCH 900475
  • MK3475
  • SCH-900475
  • BCD-201
  • Pembrolizumab Biosimilar BCD-201
  • Pembrolizumab Biosimilar QL2107
  • QL2107
  • GME 751
  • GME751
  • Pembrolizumab Biosimilar GME751
  • MK 3475
  • SCH900475
  • Pembrolizumab Biosimilar RPH-075
  • RPH 075
  • RPH-075
  • RPH075
  • Pembrolizumab biosimilar sb27
  • SB 27
  • SB-27
  • Sb27
Biologisk: Sacituzumab Govitecan

Given IV

Andra namn:
  • IMMU-132
  • Trodelvy
  • Sacituzumab Govitecan-hziy
  • hRS7-SN38 antikroppsläkemedelskonjugat
  • RS7-SN38
  • IMMU 132
  • IMMU132
  • RS7 SN38
  • RS7SN38

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall survival (OS)
Tidsram: From randomization to death due to any cause, assessed up to 5 years

OS will be characterized with the method of Kaplan-Meier and will be compared between the two treatment arms using stratified log-rank test. The hazard ratio (HR) will be estimated, and a 95% confidence interval (CI) will be reported.
From randomization to death due to any cause, assessed up to 5 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Progression-free survival (PFS)
Tidsram: From randomization to the earlier progression or death due to any cause, assessed up to 5 years

PFS will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. PFS will be characterized with the method of Kaplan-Meier and will be compared between the two treatment arms using stratified log-rank test. The HR will be estimated, and a 95% CI will be reported.
From randomization to the earlier progression or death due to any cause, assessed up to 5 years
Overall response rate (ORR)
Tidsram: Up to 5 years

ORR will be assessed among patients who received at least one dose of protocol therapy using RECIST v 1.1 criteria. ORR will be defined as the number of patients with complete response (CR) and partial response (PR) divided by the number of treated patients. ORR will be calculated based on the definition by arm and will be reported with 95% CI.
Up to 5 years
Clinical benefit rate (CBR)
Tidsram: Up to 5 years

CBR will be defined as CR, PR, or stable disease per RECIST v 1.1. CBR will be calculated based on the definition by arm and will be reported with 95% CI.
Up to 5 years
Duration of response (DOR)
Tidsram: From the first occurrence of a documented objective response to disease progression or death, whichever occurs first, assessed up to 5 years

DOR will be assessed by RECIST v1.1. DOR will be characterized with the method of Kaplan-Meier and will be compared between the two treatment arms using stratified log-rank test. The HR will be estimated, and a 95% CI will be reported.
From the first occurrence of a documented objective response to disease progression or death, whichever occurs first, assessed up to 5 years
Incidence of adverse events (AEs)
Tidsram: Up to 30 days after last dose of study drug

AEs will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The percentage of patients with toxicities will be tabulated. The 90% CI for the true probability of observing toxicity of ≥ grade 4 on a given arm will be no wider than 12.3 %. The probability of observing ≥ 1 toxicity on a given arm with a true rate of 1% is 85.5%.
Up to 30 days after last dose of study drug

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBISI-18) summary score
Tidsram: At baseline and at 3, 6 and 12 months

Change in patient reported FBISI-18 score will be compared between arms using a two-sample t-test. Assessment time will be considered as a continuous variable if there is a linear trend in quality of life (QOL) assessments over time or a set of dummy variables if a non-linear trend exists. Patient demographics and disease characteristics will be adjusted in the mixed effect model. A t-test will be performed to explore change of FBISI-18 summary score.
At baseline and at 3, 6 and 12 months
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) summary score
Tidsram: At baseline and at 3, 6 and 12 months

Change in patient reported FACIT-F score will be compared between arms using a two-sample t-test. Mixed effect models will be constructed to estimate the time profile of FACIT-F in the two arms and to evaluate treatment-by-time interactions. Assessment time will be considered as a continuous variable if there is a linear trend in QOL assessments over time or a set of dummy variables if a non-linear trend exists. Patient demographics and disease characteristics will be adjusted in the mixed effect model.
At baseline and at 3, 6 and 12 months
Change in quality-adjusted survival (assessed by the European Quality of Life Five Dimension Five Level scale [EQ-5D-5L]).
Tidsram: At baseline and at 3, 6 and 12 months

Change in patient reported EQ-5D-5L will be compared between the arms using a two-sample t-test. Quality-adjusted survival (assessed by the EQ-5D-5L), will be analyzed with quality-adjusted time without symptoms or toxicity.
At baseline and at 3, 6 and 12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Cancer Institute (NCI)

Utredare

  • Huvudutredare: Monika Joshi, ECOG-ACRIN Cancer Research Group

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

2 december 2025

Primärt slutförande (Beräknad)

31 december 2030

Avslutad studie (Beräknad)

31 december 2030

Studieregistreringsdatum

Först inskickad

26 juli 2024

Först inskickad som uppfyllde QC-kriterierna

26 juli 2024

Första postat (Faktisk)

29 juli 2024

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 november 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NCI-2024-06208
  • U10CA180820 (U.S.S. NIH-anslag/kontrakt)
  • NCI-2024-06208 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
  • EA8231 (Annan identifierare: CTEP)
  • EA8231 (Annan identifierare: ECOG-ACRIN Cancer Research Group)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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