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NCT06524544 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitecan Versus Standard of Care in the Treatment of Advanced Urothelial Cancer
A Phase 3 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 3
- Development phase
- 320
- Enrollment target
- 20
- Study locations
NCT06524544: Recruiting Phase 3 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).
NCT06524544 is a Phase 3 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 320 participants, above the 120-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (167% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06524544, a Phase 3 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 320 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares the effectiveness of pembrolizumab and sacituzumab govitecan 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 is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug called govitecan. Sacituzumab attaches to TROP2 positive tumor cells in a targeted way and delivers govitecan 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 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Docetaxel
- DRUG Cisplatin
Study Locations (20)
Illinois
- Carle at The Riverfront - Danville
- Cancer Care Specialists of Illinois - Decatur - Decatur
- Decatur Memorial Hospital - Decatur
- Carle Physician Group-Effingham - Effingham
- Crossroads Cancer Center - Effingham
- Carle Physician Group-Mattoon/Charleston - Mattoon
- Carle BroMenn Medical Center - Normal
- Carle Cancer Institute Normal - Normal
- Memorial Hospital East - Shiloh
- Southern Illinois University School of Medicine - Springfield
- Springfield Clinic - Springfield
- Springfield Memorial Hospital - Springfield
- Carle Cancer Center - Urbana
Idaho
- Kootenai Health - Coeur d'Alene - Coeur d'Alene
- Kootenai Clinic Cancer Services - Post Falls - Post Falls
- Kootenai Clinic Cancer Services - Sandpoint - Sandpoint
California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
Florida
- UF Health Cancer Institute - Gainesville - Gainesville
Iowa
- Mary Greeley Medical Center - Ames
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2025-12-02 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 3 |
What NCT06524544 shows while recruiting
NCT06524544 is an interventional study that assigns participants to a tested intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, above the 120-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (167% higher).
The record links to 3 conditions, with Metastatic Urothelial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT06524544 names 20 study sites across 5 states, led by Illinois, Idaho, California.
Frequently Asked Questions
What is clinical trial NCT06524544 about?
NCT06524544 is a clinical study titled "A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitecan Versus Standard of Care in the Treatment of Advanced Urothelial Cancer". This phase III trial compares the effectiveness of pembrolizumab and sacituzumab govitecan 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 wit...
What is the current status of trial NCT06524544?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 320 participants. The study started on 2025-12-02. Estimated completion is 2028-12-31.
What conditions does trial NCT06524544 study?
This clinical trial studies the following conditions: Metastatic Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma, Unresectable Urothelial Carcinoma.
What interventions are being tested in trial NCT06524544?
The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Docetaxel (DRUG), Cisplatin (DRUG).
Who is sponsoring clinical trial NCT06524544?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06524544 being conducted?
This trial has 20 study locations across California, Florida, Idaho, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06524544's enrollment target sits among peer trials
320 5th of 30 higher than 26 of 30 other Metastatic Urothelial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Urothelial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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