Study Comparing Ivonescimab and Enfortumab Vedotin with Pembrolizumab and Enfortumab Vedotin for Advanced Bladder Cancer
Sponsor: Summit Therapeutics
ClinicalTrials ID:NCT07815665
This clinical trial is testing two different drug combinations to see which is more effective and safe for treating advanced bladder cancer that has not been treated before.
Patient Parameters
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Program Overview
The study aims to compare the effectiveness and safety of two drug combinations for treating advanced bladder cancer. One combination includes Ivonescimab and Enfortumab Vedotin, while the other includes Pembrolizumab and Enfortumab Vedotin. The trial will help determine which combination works better for patients who have not received prior treatment for their advanced cancer.
Description
This study is divided into two parts. In the first part (Phase 2), researchers will test two different doses of Ivonescimab combined with Enfortumab Vedotin to find the safest and most effective dose for the next phase. Participants will be randomly assigned to receive one of the two doses.
- Arm A: Ivonescimab Dose 1 + Enfortumab Vedotin
- Arm B: Ivonescimab Dose 2 + Enfortumab Vedotin
In the second part (Phase 3), the study will compare the best dose of Ivonescimab plus Enfortumab Vedotin with Pembrolizumab plus Enfortumab Vedotin to see which combination is more effective and safe.
- Arm 1 (experimental): Ivonescimab (best dose) + Enfortumab Vedotin
- Arm 2 (standard care): Pembrolizumab 200 mg + Enfortumab Vedotin
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older
- Good overall health with an ECOG performance status of 0 or 1
- Expected to live at least 6 more months
- Diagnosed with advanced bladder cancer that cannot be removed by surgery, with at least 50% of the cancer being urothelial carcinoma
- No previous treatment with systemic therapy for advanced bladder cancer
- At least one measurable tumor outside the brain
- Good organ function
Exclusion Criteria
- Cancer that can be surgically removed or treated with local therapy to cure it
- Tumors with small cell or neuroendocrine features
- Ongoing nerve problems causing numbness or weakness (Grade 2 or higher)
- High risk of bleeding based on imaging tests
- History of serious digestive tract issues like perforation, blockage, or major surgery within the last 6 months
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 85054 | Phoenix | Arizona |
| Research Site | 90067 | Los Angeles | California |
| Research Site | 20010 | Washington D.C. | District of Columbia |
| Research Site | 32224 | Jacksonville | Florida |
| Research Site | 55905 | Rochester | Minnesota |
| Research Site | 37203 | Nashville | Tennessee |
| Research Site | 99208 | Spokane | Washington |
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