A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitecan-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer (NCT06524544)
A Phase III Randomized Trial of Pembrolizumab in Combination With Sacituzumab Govitecan-hziy vs Standard of Care in Anti-PD(L)1-Resistant Advanced Urothelial Cancer
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Cancer Center at Saint Joseph's — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (161 Sites)
Showing the first 25 of 161 sites.
- Cancer Center at Saint Joseph's — Phoenix, Arizona
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California
- UF Health Cancer Institute - Gainesville — Gainesville, Florida
- Emory University Hospital Midtown — Atlanta, Georgia
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia
- Emory Saint Joseph's Hospital — Atlanta, Georgia
- Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho
- Kootenai Clinic Cancer Services - Post Falls — Post Falls, Idaho
- Kootenai Clinic Cancer Services - Sandpoint — Sandpoint, Idaho
- University of Illinois — Chicago, Illinois
- Carle at The Riverfront — Danville, Illinois
- Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois
- Decatur Memorial Hospital — Decatur, Illinois
- Carle Physician Group-Effingham — Effingham, Illinois
- Crossroads Cancer Center — Effingham, Illinois
- Carle Physician Group-Mattoon/Charleston — Mattoon, Illinois
- Carle BroMenn Medical Center — Normal, Illinois
- Carle Cancer Institute Normal — Normal, Illinois
- Cancer Care Center of O'Fallon — O'Fallon, Illinois
- HSHS Saint Elizabeth's Hospital — O'Fallon, Illinois
- Memorial Hospital East — Shiloh, Illinois
- Southern Illinois University School of Medicine — Springfield, Illinois
- Springfield Clinic — Springfield, Illinois
- Springfield Memorial Hospital — Springfield, Illinois
📞 Contact the Study Coordinator
Phone: (720) 874-1881
Email: ResearchInstituteInquiries@CommonSpirit.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Locally Advanced Urothelial Carcinoma
- Testing the Addition of Tazemetostat to the Immunotherapy Drug, Pembrolizumab (MK-3475), in Advanced Urothelial Carcinoma — Phoenix, Arizona
- Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations — Boston, Massachusetts
- Consolidative Local Therapy (CLT) in Oligo-metastatic Urothelial Carcinoma — New Haven, Connecticut
Explore by condition: All Locally Advanced Urothelial Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.