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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: National Cancer Institute (NCI) • ClinicalTrials.gov ID: NCT06524544

Registry updated: 2026-10-05
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Description

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.

Interventions

  • Biospecimen Collection (Procedure)
    Undergo blood sample collection
  • Carboplatin (Drug)
    Given IV
  • Cisplatin (Drug)
    Given IV
  • Computed Tomography (Procedure)
    Undergo CT
  • Docetaxel (Drug)
    Given IV
  • Gemcitabine (Drug)
    Given IV
  • Magnetic Resonance Imaging (Procedure)
    Undergo MRI
  • Paclitaxel (Drug)
    Given IV
  • Pembrolizumab (Biological)
    Given IV
  • Questionnaire Administration (Other)
    Ancillary studies
  • Sacituzumab Govitecan (Biological)
    Given IV

Eligibility criteria

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 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 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 g/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

Conditions

Locally Advanced Urothelial Carcinoma Metastatic Urothelial Carcinoma Unresectable Urothelial Carcinoma

Locations

  • Cancer Center at Saint Joseph's — Phoenix, Arizona, United States
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
  • UF Health Cancer Institute - Gainesville — Gainesville, Florida, United States
  • Emory University Hospital Midtown — Atlanta, Georgia, United States
  • Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
  • Emory Saint Joseph's Hospital — Atlanta, Georgia, United States
  • Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho, United States
  • Kootenai Clinic Cancer Services - Post Falls — Post Falls, Idaho, United States
  • Kootenai Clinic Cancer Services - Sandpoint — Sandpoint, Idaho, United States
  • University of Illinois — Chicago, Illinois, United States
  • Carle at The Riverfront — Danville, Illinois, United States
  • Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois, United States
  • Decatur Memorial Hospital — Decatur, Illinois, United States
  • Carle Physician Group-Effingham — Effingham, Illinois, United States
  • Crossroads Cancer Center — Effingham, Illinois, United States
  • Carle Physician Group-Mattoon/Charleston — Mattoon, Illinois, United States
  • Carle BroMenn Medical Center — Normal, Illinois, United States
  • Carle Cancer Institute Normal — Normal, Illinois, United States
  • Cancer Care Center of O'Fallon — O'Fallon, Illinois, United States
  • HSHS Saint Elizabeth's Hospital — O'Fallon, Illinois, United States
  • Memorial Hospital East — Shiloh, Illinois, United States
  • Southern Illinois University School of Medicine — Springfield, Illinois, United States
  • Springfield Clinic — Springfield, Illinois, United States
  • Springfield Memorial Hospital — Springfield, Illinois, United States
  • Carle Cancer Center — Urbana, Illinois, United States
  • Mary Greeley Medical Center — Ames, Iowa, United States
  • McFarland Clinic - Ames — Ames, Iowa, United States
  • McFarland Clinic - Boone — Boone, Iowa, United States
  • Mercy Hospital — Cedar Rapids, Iowa, United States
  • Oncology Associates at Mercy Medical Center — Cedar Rapids, Iowa, United States
  • McFarland Clinic - Trinity Cancer Center — Fort Dodge, Iowa, United States
  • McFarland Clinic - Jefferson — Jefferson, Iowa, United States
  • McFarland Clinic - Marshalltown — Marshalltown, Iowa, United States
  • HaysMed — Hays, Kansas, United States
  • University of Kansas Cancer Center — Kansas City, Kansas, United States
  • Lawrence Memorial Hospital — Lawrence, Kansas, United States
  • The University of Kansas Cancer Center - Olathe — Olathe, Kansas, United States
  • University of Kansas Cancer Center-Overland Park — Overland Park, Kansas, United States
  • Salina Regional Health Center — Salina, Kansas, United States
  • University of Kansas Health System Saint Francis Campus — Topeka, Kansas, United States
  • University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas, United States
  • The James Graham Brown Cancer Center at University of Louisville — Louisville, Kentucky, United States
  • UofL Health Medical Center Northeast — Louisville, Kentucky, United States
  • Louisiana Hematology Oncology Associates LLC — Baton Rouge, Louisiana, United States
  • Mary Bird Perkins Cancer Center - Metairie — Metairie, Louisiana, United States
  • UMass Memorial Medical Center - University Campus — Worcester, Massachusetts, United States
  • Trinity Health IHA Medical Group Hematology Oncology - Brighton — Brighton, Michigan, United States
  • Trinity Health IHA Medical Group Hematology Oncology - Canton — Canton, Michigan, United States
  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital — Chelsea, Michigan, United States
  • University of Michigan Health - Sparrow Lansing — Lansing, Michigan, United States
  • Trinity Health Saint Mary Mercy Livonia Hospital — Livonia, Michigan, United States
  • Trinity Health Saint Joseph Mercy Oakland Hospital — Pontiac, Michigan, United States
  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus — Ypsilanti, Michigan, United States
  • Essentia Health Saint Joseph's Medical Center — Brainerd, Minnesota, United States
  • Mercy Hospital — Coon Rapids, Minnesota, United States
  • Essentia Health - Deer River Clinic — Deer River, Minnesota, United States
  • Essentia Health Cancer Center — Duluth, Minnesota, United States
  • Fairview Southdale Hospital — Edina, Minnesota, United States
  • Essentia Health Hibbing Clinic — Hibbing, Minnesota, United States
  • Avera Cancer Institute at Marshall — Marshall, Minnesota, United States
  • Abbott-Northwestern Hospital — Minneapolis, Minnesota, United States
  • Park Nicollet Clinic - Saint Louis Park — Saint Louis Park, Minnesota, United States
  • Regions Hospital — Saint Paul, Minnesota, United States
  • United Hospital — Saint Paul, Minnesota, United States
  • Essentia Health Sandstone — Sandstone, Minnesota, United States
  • Essentia Health Virginia Clinic — Virginia, Minnesota, United States
  • Saint Francis Medical Center — Cape Girardeau, Missouri, United States
  • Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters, Missouri, United States
  • Siteman Cancer Center at West County Hospital — Creve Coeur, Missouri, United States
  • Parkland Health Center - Farmington — Farmington, Missouri, United States
  • University Health Truman Medical Center — Kansas City, Missouri, United States
  • University of Kansas Cancer Center - Briarcliff — Kansas City, Missouri, United States
  • University of Kansas Cancer Center - North — Kansas City, Missouri, United States
  • University of Kansas Cancer Center - Lee's Summit — Lee's Summit, Missouri, United States
  • Sainte Genevieve County Memorial Hospital — Sainte Genevieve, Missouri, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • Siteman Cancer Center-South County — St Louis, Missouri, United States
  • Missouri Baptist Medical Center — St Louis, Missouri, United States
  • Siteman Cancer Center at Christian Hospital — St Louis, Missouri, United States
  • Missouri Baptist Sullivan Hospital — Sullivan, Missouri, United States
  • Community Hospital of Anaconda — Anaconda, Montana, United States
  • Billings Clinic Cancer Center — Billings, Montana, United States
  • Bozeman Health Deaconess Hospital — Bozeman, Montana, United States
  • Benefis Sletten Cancer Institute — Great Falls, Montana, United States
  • Logan Health Medical Center — Kalispell, Montana, United States
  • Community Medical Center — Missoula, Montana, United States
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center — Lebanon, New Hampshire, United States
  • Cooperman Barnabas Medical Center — Livingston, New Jersey, United States
  • Monmouth Medical Center — Long Branch, New Jersey, United States
  • Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
  • Rutgers New Jersey Medical School — Newark, New Jersey, United States
  • Robert Wood Johnson University Hospital Somerset — Somerville, New Jersey, United States
  • Community Medical Center — Toms River, New Jersey, United States
  • Roswell Park Cancer Institute — Buffalo, New York, United States
  • Stony Brook University Medical Center — Stony Brook, New York, United States
  • Roswell Park Amherst Center — Williamsville, New York, United States
  • Margaret R Pardee Memorial Hospital — Hendersonville, North Carolina, United States
  • Essentia Health Cancer Center-South University Clinic — Fargo, North Dakota, United States
  • Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
  • University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
  • Geisinger Medical Center — Danville, Pennsylvania, United States
  • Geisinger Cancer Center Dickson City — Dickson City, Pennsylvania, United States
  • UPMC Hillman Cancer Center Erie — Erie, Pennsylvania, United States
  • Saint Vincent Hospital — Erie, Pennsylvania, United States
  • UPMC Cancer Centers - Arnold Palmer Pavilion — Greensburg, Pennsylvania, United States
  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus — Harrisburg, Pennsylvania, United States
  • Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
  • IRMC Cancer Center — Indiana, Pennsylvania, United States
  • Jefferson Hospital — Jefferson Hills, Pennsylvania, United States
  • Geisinger Medical Oncology-Lewisburg — Lewisburg, Pennsylvania, United States
  • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion — Mechanicsburg, Pennsylvania, United States
  • Forbes Hospital — Monroeville, Pennsylvania, United States
  • UPMC Hillman Cancer Center - Monroeville — Monroeville, Pennsylvania, United States
  • Allegheny Valley Hospital — Natrona Heights, Pennsylvania, United States
  • Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
  • UPMC-Saint Margaret — Pittsburgh, Pennsylvania, United States
  • West Penn Hospital — Pittsburgh, Pennsylvania, United States
  • UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
  • UPMC-Passavant Hospital — Pittsburgh, Pennsylvania, United States
  • UPMC Cancer Center at UPMC Northwest — Seneca, Pennsylvania, United States
  • UPMC Cancer Center-Uniontown — Uniontown, Pennsylvania, United States
  • UPMC Cancer Center-Washington — Washington, Pennsylvania, United States
  • Reading Hospital — West Reading, Pennsylvania, United States
  • Wexford Health and Wellness Pavilion — Wexford, Pennsylvania, United States
  • Geisinger Wyoming Valley/Henry Cancer Center — Wilkes-Barre, Pennsylvania, United States
  • Avera Cancer Institute-Aberdeen — Aberdeen, South Dakota, United States
  • Avera Cancer Institute - Mitchell — Mitchell, South Dakota, United States
  • Avera Cancer Institute at Pierre — Pierre, South Dakota, United States
  • Avera Cancer Institute — Sioux Falls, South Dakota, United States
  • Avera Cancer Institute at Yankton — Yankton, South Dakota, United States
  • Houston Methodist San Jacinto Hospital — Baytown, Texas, United States
  • Houston Methodist Cypress Hospital — Cypress, Texas, United States
  • Parkland Memorial Hospital — Dallas, Texas, United States
  • UT Southwestern Simmons Cancer Center - RedBird — Dallas, Texas, United States
  • UT Southwestern/Simmons Cancer Center-Dallas — Dallas, Texas, United States
  • UT Southwestern/Simmons Cancer Center-Fort Worth — Fort Worth, Texas, United States
  • Houston Methodist Hospital — Houston, Texas, United States
  • Methodist Willowbrook Hospital — Houston, Texas, United States
  • Houston Methodist West Hospital — Houston, Texas, United States
  • Houston Methodist Saint John Hospital — Nassau Bay, Texas, United States
  • UT Southwestern Clinical Center at Richardson/Plano — Richardson, Texas, United States
  • Houston Methodist Sugar Land Hospital — Sugar Land, Texas, United States
  • Houston Methodist The Woodlands Hospital — The Woodlands, Texas, United States
  • Central Vermont Medical Center/National Life Cancer Treatment — Berlin Corners, Vermont, United States
  • University of Vermont Medical Center — Burlington, Vermont, United States
  • University of Vermont and State Agricultural College — Burlington, Vermont, United States
  • Dartmouth Cancer Center - North — Saint Johnsbury, Vermont, United States
  • Hematology Oncology Associates of Fredericksburg Inc — Fredericksburg, Virginia, United States
  • Virginia Cancer Institute — Richmond, Virginia, United States
  • VCU Massey Cancer Center at Stony Point — Richmond, Virginia, United States
  • VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States
  • FHCC Overlake — Bellevue, Washington, United States
  • FHCC at EvergreenHealth — Kirkland, Washington, United States
  • Fred Hutchinson Cancer Center — Seattle, Washington, United States
  • FHCC at Northwest Hospital — Seattle, Washington, United States
  • University of Washington Medical Center - Montlake — Seattle, Washington, United States
  • Vandalia Health/CAMC Institute for Academic Medicine — Charleston, West Virginia, United States
  • ThedaCare Regional Cancer Center — Appleton, Wisconsin, United States
  • Duluth Clinic Ashland — Ashland, Wisconsin, United States
  • Gundersen Lutheran Medical Center — La Crosse, Wisconsin, United States
  • Cancer Center of Western Wisconsin — New Richmond, Wisconsin, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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