Study on New Treatments for Advanced Urothelial Cancer Resistant to PD-1/L1 Inhibitors
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT05562830
This clinical trial is exploring new treatment options for patients with advanced urothelial cancer that has not responded to PD-1/L1 inhibitors. The study will test different investigational drugs, with or without pembrolizumab, to find effective therapies for these patients.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is part of a larger research project aimed at finding new treatments for urothelial cancer, which affects the bladder and urinary tract. It focuses on patients whose cancer has not responded to existing treatments called PD-1/L1 inhibitors. The study will test new drugs, either alone or with pembrolizumab, to see if they can help control the cancer. Participants will be assigned to different treatment groups based on their specific condition and treatment history.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced urothelial cancer that cannot be removed by surgery, affecting areas like the bladder or urethra.
- For Arm A: Cancer must have progressed during or after treatment with PD-1/L1 inhibitors, either alone or with other therapies.
- For Arm A: Must provide a tumor sample for testing, which has not been treated with radiation.
- For Arm B: Cancer must have progressed after treatment with PD-1/L1 inhibitors, either alone or with other therapies, more than 12 months after the last dose.
- For Arm B: Must provide a tumor sample from a metastatic site or a primary tumor that has advanced, which has not been treated with radiation.
Exclusion Criteria
- Have another type of cancer that is progressing or needed treatment in the last 3 years.
- Have received any cancer treatment, including experimental drugs, within 4 weeks before joining the study.
- Have an active infection that requires treatment.
- Have received a live vaccine within 30 days before starting the study treatment. Inactivated vaccines are allowed.
- Have a known history of HIV.
- Have a known history of hepatitis B or C infection.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 1045) | 92868 | Orange | California |
| University of California San Francisco ( Site 1044) | 94158 | San Francisco | California |
| Anschutz Cancer Pavilion ( Site 1017) | 80045 | Aurora | Colorado |
| University of Chicago Medical Center ( Site 1037) | 60637 | Chicago | Illinois |
| Indiana University Melvin and Bren Simon Cancer Center ( Site 1011) | 46202 | Indianapolis | Indiana |
| Siteman Cancer Center ( Site 1038) | 63108 | St Louis | Missouri |
| Cleveland Clinic-Taussig Cancer Center ( Site 1036) | 44195 | Cleveland | Ohio |
| UPMC Hillman Cancer Center ( Site 1014) | 15232 | Pittsburgh | Pennsylvania |
| Huntsman Cancer Institute ( Site 1041) | 84112-5500 | Salt Lake City | Utah |
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