A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitean-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer

May 30, 2026 updated by: National Cancer Institute (NCI)

A Phase III Randomized Trial of Pembrolizumab in Combination With Sacituzumab Govitean-hziy vs Standard of Care in Anti-PD(L)1-Resistant Advanced Urothelial Cancer

This phase III trial compares the effectiveness of pembrolizumab and sacituzumab govitean-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 govitean-hziy is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug called govitean-hziy. Sacituzumab attaches to TROP2 positive tumor cells in a targeted way and delivers govitean-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 govitean-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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

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

SECONDARY OBJECTIVES:

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

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

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

V. To evaluate toxicity of the Sacituzumab govitean-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 govitean-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 theSacituzumab govitean-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 govitean-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 govitean-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 govitean-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 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 computed tomography (CT) or magnetic resonance imaging (MRI) throughout the study.

ARM B: Patients receive Sacituzumab govitean-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 govitean-hziy repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients additional 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.

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
    • California
      • Irvine, California, United States, 92612
        • Recruiting
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
        • Contact:
        • Principal Investigator:
          • Nataliya Mar
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Nataliya Mar
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • UF Health Cancer Institute - Gainesville
        • Principal Investigator:
          • Daniel V. Araujo
        • Contact:
          • Site Public Contact
          • Phone Number: 352-273-8010
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
        • Principal Investigator:
          • Jacqueline T. Brown
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Contact:
          • Site Public Contact
          • Phone Number: 888-946-7447
        • Principal Investigator:
          • Jacqueline T. Brown
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Emory Saint Joseph's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 404-851-7115
        • Principal Investigator:
          • Jacqueline T. Brown
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Recruiting
        • Kootenai Health - Coeur d'Alene
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Post Falls, Idaho, United States, 83854
        • Recruiting
        • Kootenai Clinic Cancer Services - Post Falls
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Sandpoint, Idaho, United States, 83864
        • Recruiting
        • Kootenai Clinic Cancer Services - Sandpoint
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
        • Contact:
          • Site Public Contact
          • Phone Number: 312-355-3046
        • Principal Investigator:
          • Karine Tawagi
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois - Decatur
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Decatur Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Normal, Illinois, United States, 61761
        • Recruiting
        • Carle BroMenn Medical Center
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Normal, Illinois, United States, 61761
        • Recruiting
        • Carle Cancer Institute Normal
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Shiloh, Illinois, United States, 62269
        • Recruiting
        • Memorial Hospital East
        • Contact:
        • Principal Investigator:
          • Melissa A. Reimers
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 800-444-7541
      • Springfield, Illinois, United States, 62781
        • Recruiting
        • Springfield Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
    • Iowa
      • Ames, Iowa, United States, 50010
        • Recruiting
        • Mary Greeley Medical Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Ames, Iowa, United States, 50010
        • Recruiting
        • McFarland Clinic - Ames
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
      • Boone, Iowa, United States, 50036
        • Suspended
        • McFarland Clinic - Boone
      • Cedar Rapids, Iowa, United States, 52403
        • Recruiting
        • Mercy Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 319-365-4673
        • Principal Investigator:
          • Deborah W. Wilbur
      • Cedar Rapids, Iowa, United States, 52403
        • Recruiting
        • Oncology Associates at Mercy Medical Center
        • Principal Investigator:
          • Deborah W. Wilbur
        • Contact:
          • Site Public Contact
          • Phone Number: 319-363-2690
      • Fort Dodge, Iowa, United States, 50501
        • Recruiting
        • McFarland Clinic - Trinity Cancer Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Jefferson, Iowa, United States, 50129
        • Suspended
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, United States, 50158
        • Recruiting
        • McFarland Clinic - Marshalltown
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
    • Kansas
      • Hays, Kansas, United States, 67601
        • Recruiting
        • HaysMed
        • Principal Investigator:
          • Saqib Abbasi
        • Contact:
          • Site Public Contact
          • Phone Number: 785-623-5774
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Cancer Center
        • Principal Investigator:
          • Saqib Abbasi
        • Contact:
      • Olathe, Kansas, United States, 66061
        • Recruiting
        • The University of Kansas Cancer Center - Olathe
        • Principal Investigator:
          • Saqib Abbasi
        • Contact:
      • Overland Park, Kansas, United States, 66210
        • Recruiting
        • University of Kansas Cancer Center-Overland Park
        • Principal Investigator:
          • Saqib Abbasi
        • Contact:
      • Salina, Kansas, United States, 67401
        • Recruiting
        • Salina Regional Health Center
        • Principal Investigator:
          • Saqib Abbasi
        • Contact:
      • Topeka, Kansas, United States, 66606
        • Recruiting
        • University of Kansas Health System Saint Francis Campus
        • Principal Investigator:
          • Saqib Abbasi
        • Contact:
          • Site Public Contact
          • Phone Number: 785-295-8000
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Hospital-Westwood Cancer Center
        • Principal Investigator:
          • Saqib Abbasi
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • The James Graham Brown Cancer Center at University of Louisville
        • Principal Investigator:
          • Rohit Kumar
        • Contact:
          • Site Public Contact
          • Phone Number: 502-562-3429
      • Louisville, Kentucky, United States, 40245
        • Recruiting
        • UofL Health Medical Center Northeast
        • Principal Investigator:
          • Rohit Kumar
        • Contact:
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Recruiting
        • Louisiana Hematology Oncology Associates LLC
        • Contact:
        • Principal Investigator:
          • Scott E. Delacroix
      • Metairie, Louisiana, United States, 70002
        • Recruiting
        • Mary Bird Perkins Cancer Center - Metairie
        • Principal Investigator:
          • Scott E. Delacroix
        • Contact:
          • Site Public Contact
          • Phone Number: 504-584-6990
    • Michigan
      • Brighton, Michigan, United States, 48114
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contact:
        • Principal Investigator:
          • Houssam Y. Hariri
      • Canton, Michigan, United States, 48188
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contact:
        • Principal Investigator:
          • Houssam Y. Hariri
      • Chelsea, Michigan, United States, 48118
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contact:
        • Principal Investigator:
          • Houssam Y. Hariri
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • University of Michigan Health - Sparrow Lansing
        • Contact:
        • Principal Investigator:
          • Houssam Y. Hariri
      • Livonia, Michigan, United States, 48154
        • Recruiting
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contact:
        • Principal Investigator:
          • Houssam Y. Hariri
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Contact:
        • Principal Investigator:
          • Houssam Y. Hariri
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contact:
        • Principal Investigator:
          • Houssam Y. Hariri
    • Minnesota
      • Brainerd, Minnesota, United States, 56401
        • Recruiting
        • Essentia Health Saint Joseph's Medical Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Mercy Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Deer River, Minnesota, United States, 56636
        • Recruiting
        • Essentia Health - Deer River Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Essentia Health Cancer Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Fairview Southdale Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Hibbing, Minnesota, United States, 55746
        • Recruiting
        • Essentia Health Hibbing Clinic
        • Principal Investigator:
          • Bret E. Friday
        • Contact:
          • Site Public Contact
          • Phone Number: 218-786-3308
      • Marshall, Minnesota, United States, 56258
        • Recruiting
        • Avera Cancer Institute at Marshall
        • Contact:
        • Principal Investigator:
          • Ryan A. Vaca
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott-Northwestern Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Park Nicollet Clinic - Saint Louis Park
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Paul, Minnesota, United States, 55102
        • Recruiting
        • United Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Sandstone, Minnesota, United States, 55072
        • Recruiting
        • Essentia Health Sandstone
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Virginia, Minnesota, United States, 55792
        • Recruiting
        • Essentia Health Virginia Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Saint Francis Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-334-2230
          • Email: sfmc@sfmc.net
      • City of Saint Peters, Missouri, United States, 63376
        • Recruiting
        • Siteman Cancer Center at Saint Peters Hospital
        • Contact:
        • Principal Investigator:
          • Melissa A. Reimers
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • Siteman Cancer Center at West County Hospital
        • Contact:
        • Principal Investigator:
          • Melissa A. Reimers
      • Farmington, Missouri, United States, 63640
        • Recruiting
        • Parkland Health Center - Farmington
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Kansas City, Missouri, United States, 64154
        • Recruiting
        • University of Kansas Cancer Center - North
        • Principal Investigator:
          • Saqib Abbasi
        • Contact:
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • University Health Truman Medical Center
        • Principal Investigator:
          • Saqib Abbasi
        • Contact:
          • Site Public Contact
          • Phone Number: 816-404-4375
      • Kansas City, Missouri, United States, 64116
        • Recruiting
        • University of Kansas Cancer Center - Briarcliff
        • Principal Investigator:
          • Saqib Abbasi
        • Contact:
          • Site Public Contact
          • Phone Number: 913-588-3671
      • Lee's Summit, Missouri, United States, 64064
        • Recruiting
        • University of Kansas Cancer Center - Lee's Summit
        • Principal Investigator:
          • Saqib Abbasi
        • Contact:
      • Sainte Genevieve, Missouri, United States, 63670
        • Recruiting
        • Sainte Genevieve County Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Melissa A. Reimers
      • St Louis, Missouri, United States, 63129
        • Recruiting
        • Siteman Cancer Center-South County
        • Contact:
        • Principal Investigator:
          • Melissa A. Reimers
      • St Louis, Missouri, United States, 63136
        • Recruiting
        • Siteman Cancer Center at Christian Hospital
        • Contact:
        • Principal Investigator:
          • Melissa A. Reimers
      • St Louis, Missouri, United States, 63131
        • Recruiting
        • Missouri Baptist Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Sullivan, Missouri, United States, 63080
        • Recruiting
        • Missouri Baptist Sullivan Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Sunset Hills, Missouri, United States, 63127
        • Recruiting
        • BJC Outpatient Center at Sunset Hills
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
    • Montana
      • Anaconda, Montana, United States, 59711
        • Recruiting
        • Community Hospital of Anaconda
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Bozeman, Montana, United States, 59715
        • Recruiting
        • Bozeman Health Deaconess Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Logan Health Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Community Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Contact:
        • Principal Investigator:
          • Jacob B. Reibel
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Recruiting
        • Saint Barnabas Medical Center
        • Contact:
        • Principal Investigator:
          • Biren Saraiya
      • Long Branch, New Jersey, United States, 07740
        • Recruiting
        • Monmouth Medical Center
        • Contact:
        • Principal Investigator:
          • Biren Saraiya
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
          • Site Public Contact
          • Phone Number: 732-235-7356
        • Principal Investigator:
          • Biren Saraiya
      • Newark, New Jersey, United States, 07101
        • Recruiting
        • Rutgers New Jersey Medical School
        • Contact:
          • Site Public Contact
          • Phone Number: 732-235-7356
        • Principal Investigator:
          • Biren Saraiya
      • Somerville, New Jersey, United States, 08876
        • Recruiting
        • Robert Wood Johnson University Hospital Somerset
        • Principal Investigator:
          • Biren Saraiya
        • Contact:
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • Community Medical Center
        • Principal Investigator:
          • Biren Saraiya
        • Contact:
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Contact:
        • Principal Investigator:
          • Ellis G. Levine
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-862-2215
        • Principal Investigator:
          • Judy Huang
    • North Carolina
      • Hendersonville, North Carolina, United States, 28791
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Recruiting
        • Essentia Health Cancer Center-South University Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Adanma Anji Ayanambakkam Attanathi
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Contact:
        • Principal Investigator:
          • Sorab Gupta
      • Dickson City, Pennsylvania, United States, 18519
        • Recruiting
        • Geisinger Cancer Center Dickson City
        • Principal Investigator:
          • Sorab Gupta
        • Contact:
      • Erie, Pennsylvania, United States, 16505
        • Recruiting
        • UPMC Hillman Cancer Center Erie
        • Principal Investigator:
          • Leonard J. Appleman
        • Contact:
      • Erie, Pennsylvania, United States, 16544
        • Recruiting
        • Saint Vincent Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 814-452-5000
        • Principal Investigator:
          • Alexander Helfand
      • Greensburg, Pennsylvania, United States, 15601
        • Recruiting
        • UPMC Cancer Centers - Arnold Palmer Pavilion
        • Contact:
          • Site Public Contact
          • Phone Number: 724-838-1900
        • Principal Investigator:
          • Leonard J. Appleman
      • Harrisburg, Pennsylvania, United States, 17109
        • Recruiting
        • UPMC Pinnacle Cancer Center/Community Osteopathic Campus
        • Contact:
        • Principal Investigator:
          • Leonard J. Appleman
      • Hershey, Pennsylvania, United States, 17033-0850
        • Recruiting
        • Penn State Milton S Hershey Medical Center
        • Contact:
        • Principal Investigator:
          • Monika Joshi
      • Indiana, Pennsylvania, United States, 15701
        • Recruiting
        • IRMC Cancer Center
        • Contact:
        • Principal Investigator:
          • Leonard J. Appleman
      • Jefferson Hills, Pennsylvania, United States, 15025
        • Recruiting
        • Jefferson Hospital
        • Contact:
        • Principal Investigator:
          • Alexander Helfand
      • Lewisburg, Pennsylvania, United States, 17837
        • Recruiting
        • Geisinger Medical Oncology-Lewisburg
        • Contact:
        • Principal Investigator:
          • Sorab Gupta
      • Mechanicsburg, Pennsylvania, United States, 17050
        • Recruiting
        • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
        • Contact:
        • Principal Investigator:
          • Leonard J. Appleman
      • Monroeville, Pennsylvania, United States, 15146
        • Recruiting
        • Forbes Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-858-7746
        • Principal Investigator:
          • Alexander Helfand
      • Monroeville, Pennsylvania, United States, 15146
        • Recruiting
        • UPMC Hillman Cancer Center - Monroeville
        • Principal Investigator:
          • Leonard J. Appleman
        • Contact:
      • Natrona Heights, Pennsylvania, United States, 15065
        • Recruiting
        • Allegheny Valley Hospital
        • Contact:
        • Principal Investigator:
          • Alexander Helfand
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Cancer Institute (UPCI)
        • Contact:
          • Site Public Contact
          • Phone Number: 412-647-8073
        • Principal Investigator:
          • Leonard J. Appleman
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • West Penn Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-578-5000
        • Principal Investigator:
          • Alexander Helfand
      • Pittsburgh, Pennsylvania, United States, 15215
        • Recruiting
        • UPMC-Saint Margaret
        • Contact:
          • Site Public Contact
          • Phone Number: 412-784-4900
        • Principal Investigator:
          • Leonard J. Appleman
      • Pittsburgh, Pennsylvania, United States, 15237
        • Recruiting
        • UPMC-Passavant Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-367-6454
        • Principal Investigator:
          • Leonard J. Appleman
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 877-284-2000
        • Principal Investigator:
          • Alexander Helfand
      • Washington, Pennsylvania, United States, 15301
        • Recruiting
        • UPMC Cancer Center-Washington
        • Contact:
        • Principal Investigator:
          • Leonard J. Appleman
      • West Reading, Pennsylvania, United States, 19611
        • Recruiting
        • Reading Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 610-988-9323
        • Principal Investigator:
          • Terrence P. Cescon
      • Wexford, Pennsylvania, United States, 15090
        • Recruiting
        • Wexford Health and Wellness Pavilion
        • Contact:
        • Principal Investigator:
          • Alexander Helfand
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Recruiting
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contact:
        • Principal Investigator:
          • Sorab Gupta
    • South Dakota
      • Aberdeen, South Dakota, United States, 57401
        • Recruiting
        • Avera Cancer Institute-Aberdeen
        • Contact:
        • Principal Investigator:
          • Ryan A. Vaca
      • Mitchell, South Dakota, United States, 57301
        • Recruiting
        • Avera Cancer Institute - Mitchell
        • Contact:
        • Principal Investigator:
          • Ryan A. Vaca
      • Pierre, South Dakota, United States, 57501
        • Recruiting
        • Avera Cancer Institute at Pierre
        • Contact:
        • Principal Investigator:
          • Ryan A. Vaca
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute
        • Contact:
        • Principal Investigator:
          • Ryan A. Vaca
      • Yankton, South Dakota, United States, 57078
        • Recruiting
        • Avera Cancer Institute at Yankton
        • Contact:
        • Principal Investigator:
          • Ryan A. Vaca
    • Texas
      • Baytown, Texas, United States, 77521
        • Recruiting
        • Houston Methodist San Jacinto Hospital
        • Contact:
        • Principal Investigator:
          • Patrick E. Prath
      • Cypress, Texas, United States, 77429
        • Recruiting
        • Houston Methodist Cypress Hospital
        • Contact:
        • Principal Investigator:
          • Patrick E. Prath
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 713-790-2700
        • Principal Investigator:
          • Patrick E. Prath
      • Houston, Texas, United States, 77070
        • Recruiting
        • Methodist Willowbrook Hospital
        • Contact:
        • Principal Investigator:
          • Patrick E. Prath
      • Houston, Texas, United States, 77094
        • Recruiting
        • Houston Methodist West Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 832-522-2873
        • Principal Investigator:
          • Patrick E. Prath
      • Nassau Bay, Texas, United States, 77058
        • Recruiting
        • Houston Methodist Saint John Hospital
        • Contact:
        • Principal Investigator:
          • Patrick E. Prath
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • Houston Methodist Sugar Land Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 281-242-2873
        • Principal Investigator:
          • Patrick E. Prath
      • The Woodlands, Texas, United States, 77385
        • Recruiting
        • Houston Methodist The Woodlands Hospital
        • Contact:
        • Principal Investigator:
          • Patrick E. Prath
    • Vermont
      • Berlin Corners, Vermont, United States, 05602
        • Recruiting
        • Central Vermont Medical Center/National Life Cancer Treatment
        • Contact:
          • Site Public Contact
          • Phone Number: 802-225-5400
        • Principal Investigator:
          • Rahul Anil
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • University of Vermont Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 802-656-4101
          • Email: rpo@uvm.edu
        • Principal Investigator:
          • Rahul Anil
      • Burlington, Vermont, United States, 05405
        • Recruiting
        • University of Vermont and State Agricultural College
        • Contact:
          • Site Public Contact
          • Phone Number: 802-656-8990
          • Email: rpo@uvm.edu
        • Principal Investigator:
          • Rahul Anil
    • Virginia
      • Fredericksburg, Virginia, United States, 22408
        • Recruiting
        • Hematology Oncology Associates of Fredericksburg Inc
        • Contact:
        • Principal Investigator:
          • Asit K. Paul
      • Richmond, Virginia, United States, 23229
        • Recruiting
        • Virginia Cancer Institute
        • Contact:
        • Principal Investigator:
          • Asit K. Paul
      • Richmond, Virginia, United States, 23235
        • Recruiting
        • VCU Massey Cancer Center at Stony Point
        • Contact:
        • Principal Investigator:
          • Asit K. Paul
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • VCU Massey Comprehensive Cancer Center
        • Principal Investigator:
          • Asit K. Paul
        • Contact:
    • Washington
      • Bellevue, Washington, United States, 98004
        • Recruiting
        • FHCC Overlake
        • Contact:
          • Site Public Contact
          • Phone Number: 425-454-2148
        • Principal Investigator:
          • Mikhail G. Perlov
      • Kirkland, Washington, United States, 98034
        • Recruiting
        • FHCC at EvergreenHealth
        • Principal Investigator:
          • Prakash Varadarajan
        • Contact:
          • Site Public Contact
          • Phone Number: 425-899-6000
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center - Montlake
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
        • Principal Investigator:
          • Petros Grivas
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
        • Principal Investigator:
          • Petros Grivas
      • Seattle, Washington, United States, 98133
        • Recruiting
        • FHCC at Northwest Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 206-606-5800
        • Principal Investigator:
          • Nellowe Candelario
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Recruiting
        • West Virginia University Charleston Division
        • Contact:
          • Site Public Contact
          • Phone Number: 304-388-9944
        • Principal Investigator:
          • Kok Hoe Chan
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • Recruiting
        • ThedaCare Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Joyce Philip
      • Ashland, Wisconsin, United States, 54806
        • Recruiting
        • Duluth Clinic Ashland
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Gundersen Lutheran Medical Center
        • Contact:
        • Principal Investigator:
          • Kurt Oettel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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 vedotinor 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 govitean-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, hemogloblin level and presence of liver metastases
  • Patient must not have history of grade 3 or higher 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 mg/dl (obtained ≤ 14 days prior to randomization)

  • Patient must not have a known genetic UGT1A1 deficiency (Gilbert's syndrome). Patients with variant type UGT1A1*28 allele may have increased levels of SN-38 metabolite (due to reduced SN-38 metabolism and clearance) and are at higher risk for severe adverse events when compared to wild-type.

    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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 days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients additional undergo blood sample collection, and CT or MRI throughout the study.
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carboplatinum
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo
  • JM8
Other: Questionnaire Administration
Ancillary studies
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Drug: Cisplatin
Given IV
Other Names:
  • CDDP
  • Cis-diamminedichloridoplatinum
  • Cismaplat
  • Cisplatinum
  • Neoplatin
  • Platinol
  • Abiplatin
  • Blastolem
  • Briplatin
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cisplatina
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
Drug: Gemcitabine
Given IV
Other Names:
  • dFdCyd
  • dFdC
  • Difluorodeoxycytidine
Drug: Paclitaxel
Given IV
Other Names:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Drug: Docetaxel
Given IV
Other Names:
  • Taxotere
  • Docecad
  • RP56976
  • Taxotere Injection Concentrate
  • RP 56976
  • RP-56976
Procedure: Computed Tomography
Undergo CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
  • Diagnostic CAT Scan
  • Diagnostic CAT Scan Service Type
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Experimental: Arm II (pembrolizumab, sacituzumab govitean-hziy)
Patients receive pembrolizumab IV over 30 minutes on day 1 and sacituzumab govitean-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 additional undergo blood sample collection, and CT or MRI throughout the study.
Other: Questionnaire Administration
Ancillary studies
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Procedure: Computed Tomography
Undergo CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
  • Diagnostic CAT Scan
  • Diagnostic CAT Scan Service Type
Biological: Pembrolizumab
Given IV
Other Names:
  • 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
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Biological: Sacituzumab Govitecan
Given IV
Other Names:
  • IMMU-132
  • Trodelvy
  • Sacituzumab Govitecan-hziy
  • hRS7-SN38 Antibody Drug Conjugate
  • RS7-SN38
  • IMMU 132
  • IMMU132
  • RS7 SN38
  • RS7SN38

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBISI-18) summary score
Time Frame: 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
Time Frame: 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]).
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Monika Joshi, ECOG-ACRIN Cancer Research Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

July 26, 2024

First Submitted That Met QC Criteria

July 26, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 30, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2024-06208 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180820 (U.S. NIH Grant/Contract)
  • EA8231 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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