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比较 Pembrolizumab 和 Sacituzumab Govitecan 组合与单独 Sacituzumab Govitecan 治疗晚期尿路上皮癌的研究

2026年11月3日 更新者：National Cancer Institute (NCI)

Pembrolizumab 联合 Sacituzumab Govitecan 与单独 Sacituzumab Govitecan 治疗抗 PD(L)1 耐药的晚期尿路上皮癌的 III 期随机试验

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

320

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：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.
药品：Carboplatin

Given IV

其他名称：
  • 芽生威
  • 卡宝
  • 卡铂六醇
  • 卡铂
  • 卡布辛
  • 卡波索尔
  • 卡博泰克
  • CBDCA
  • 迪普拉塔
  • 埃卡尔
  • JM-8
  • 内洛林
  • 新铂金
  • 副铂
  • 副铂 AQ
  • 对铂
  • 铂金瓦斯
  • 核糖体
  • JM8
药品：Paclitaxel

Given IV

其他名称：
  • 紫杉醇
  • 安扎塔克斯
  • Asotax
  • 布里他索
  • 普拉塞尔
  • 紫杉醇音乐会
药品：Cisplatin

Given IV

其他名称：
  • CDDP
  • 顺式二氨合二氯铂
  • 顺铂
  • 新铂
  • 铂醇
  • 阿比铂
  • Blastolem
  • 布铂
  • 顺式二氨二氯铂
  • 顺式二氨二氯铂 (II)
  • 顺式二氯胺铂 (II)
  • 顺铂二氯化胺
  • 顺铂II
  • 顺铂II二胺二氯化物
  • 胞铂
  • 胞磷胆素
  • 扁豆属
  • 民进党
  • 莱德铂
  • 金属铂
  • 佩龙氯化物
  • 佩龙盐
  • 普拉西斯
  • 塑化剂
  • 铂金
  • 铂菌素
  • Platiblastin-S
  • 铂金-AQ
  • Platinol-AQ VHA Plus
  • 铂氧生
  • 铂
  • 二氯化铂
  • 普拉蒂兰
  • 普拉汀
  • 柏拉图素
药品：Docetaxel

Given IV

其他名称：
  • 泰索帝
  • 多西卡德
  • RP56976
  • 泰素帝浓缩注射液
  • 零售价 56976
  • RP-56976
程序：Biospecimen Collection

Undergo blood sample collection

其他名称：
  • 生物样本采集
  • 收集的生物样本
  • 标本采集
  • 样本收集
程序：Computed Tomography

Undergo CT

其他名称：
  • CT
  • 猫
  • 电脑扫描
  • 计算机轴向断层扫描
  • 计算机断层扫描
  • CT扫描
  • 断层扫描
  • 计算机轴向断层扫描（程序）
  • 计算机断层扫描 (CT) 扫描
  • 诊断猫扫描
  • 诊断猫扫描服务类型
程序：Magnetic Resonance Imaging

Undergo MRI

其他名称：
  • 核磁共振
  • 磁共振
  • 磁共振成像扫描
  • 医学影像、磁共振/核磁共振
  • 先生
  • 磁共振成像
  • 核磁共振成像扫描
  • 核磁共振成像
  • 磁共振成像 (MRI)
  • 磁共振成像（程序）
  • 结构核磁共振
其他：Questionnaire Administration

Ancillary studies

药品：Gemcitabine

Given IV

其他名称：
  • dFdCyd
  • dFdC
  • 二氟脱氧胞苷
实验性的：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.
程序：Biospecimen Collection

Undergo blood sample collection

其他名称：
  • 生物样本采集
  • 收集的生物样本
  • 标本采集
  • 样本收集
程序：Computed Tomography

Undergo CT

其他名称：
  • CT
  • 猫
  • 电脑扫描
  • 计算机轴向断层扫描
  • 计算机断层扫描
  • CT扫描
  • 断层扫描
  • 计算机轴向断层扫描（程序）
  • 计算机断层扫描 (CT) 扫描
  • 诊断猫扫描
  • 诊断猫扫描服务类型
程序：Magnetic Resonance Imaging

Undergo MRI

其他名称：
  • 核磁共振
  • 磁共振
  • 磁共振成像扫描
  • 医学影像、磁共振/核磁共振
  • 先生
  • 磁共振成像
  • 核磁共振成像扫描
  • 核磁共振成像
  • 磁共振成像 (MRI)
  • 磁共振成像（程序）
  • 结构核磁共振
其他：Questionnaire Administration

Ancillary studies

生物：Pembrolizumab

Given IV

其他名称：
  • 可瑞达
  • MK-3475
  • 兰博利珠单抗
  • SCH 900475
  • MK3475
  • SCH-900475
  • BCD-201
  • 派姆单抗生物仿制药 BCD-201
  • 帕博利珠单抗生物类似药 QL2107
  • QL2107
  • GME 751
  • GME751
  • 派姆单抗生物仿制药 GME751
  • MK 3475
  • SCH900475
  • 派姆单抗生物仿制药 RPH-075
  • RPH 075
  • RPH-075
  • RPH075
  • Pembrolizumab生物仿制药SB27
  • SB 27
  • SB-27
  • SB27
生物：Sacituzumab Govitecan

Given IV

其他名称：
  • IMMU-132
  • 特罗德尔维
  • Sacituzumab Govitecan-hziy
  • hRS7-SN38抗体药物偶联物
  • RS7-SN38
  • 免疫测量单元132
  • RS7 SN38
  • RS7SN38

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Overall survival (OS)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Progression-free survival (PFS)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
Change in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBISI-18) summary score
大体时间：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
大体时间：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]).
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National Cancer Institute (NCI)

调查人员

  • 首席研究员：Monika Joshi、ECOG-ACRIN Cancer Research Group

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年12月2日

初级完成 (估计的)

2030年12月31日

研究完成 (估计的)

2030年12月31日

研究注册日期

首次提交

2024年7月26日

首先提交符合 QC 标准的

2024年7月26日

首次发布 (实际的)

2024年7月29日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • NCI-2024-06208
  • U10CA180820 (美国 NIH 拨款/合同)
  • NCI-2024-06208 (注册表标识符：CTRP (Clinical Trial Reporting Program))
  • EA8231 (其他标识符：CTEP)
  • EA8231 (其他标识符：ECOG-ACRIN Cancer Research Group)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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