Study on Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy for Untreated Advanced Urothelial Cancer
Sponsor: Astellas Pharma Global Development, Inc.
ClinicalTrials ID:NCT04223856
This clinical trial is comparing the effectiveness of two drugs, enfortumab vedotin and pembrolizumab, against standard chemotherapy in treating patients with advanced urothelial cancer that has spread beyond the urinary system.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate how well the combination of enfortumab vedotin and pembrolizumab works compared to standard chemotherapy in patients with advanced urothelial cancer. This cancer has spread from the urinary system to other parts of the body. The study will help determine if the new drug combination can provide better outcomes than the usual treatment options.
Description
This study is being conducted to compare the effectiveness of a new drug combination, enfortumab vedotin and pembrolizumab, against the standard chemotherapy treatment for patients with advanced urothelial cancer. Enfortumab vedotin has been approved in Japan for treating advanced urothelial cancer, and this study will continue as a post-marketing study there.
Participants will receive either the new drug combination or the standard chemotherapy, which includes gemcitabine and a platinum-based drug like cisplatin or carboplatin. Enfortumab vedotin can be given for an unlimited number of cycles until a specific reason to stop the study occurs. Pembrolizumab can be given for up to 35 cycles or until a specific reason to stop occurs. The standard chemotherapy can be given for up to 6 cycles or until a specific reason to stop occurs.
Eligibility Criteria
Inclusion Criteria
- Have advanced urothelial cancer that cannot be removed by surgery and has spread to other parts of the body.
- Have measurable cancer that can be tracked using standard criteria.
- Have not received prior treatment for advanced urothelial cancer, except in certain cases where chemotherapy was given more than 12 months ago.
- Be eligible to receive chemotherapy with cisplatin or carboplatin, as determined by the study doctor.
- Provide a tumor sample for testing before starting the study.
- Have a performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
- Have adequate blood cell counts and organ function.
Exclusion Criteria
- Have previously received enfortumab vedotin or similar drugs.
- Have received treatment with PD-1 or PD-L1 inhibitors for any cancer.
- Have received other treatments that affect the immune system within 4 weeks before starting the study.
- Have uncontrolled diabetes.
- Have a life expectancy of less than 12 weeks.
- Have active cancer that has spread to the brain or spinal cord.
- Have ongoing significant side effects from previous treatments that have not improved.
- Are currently being treated for an active infection.
- Have active hepatitis B, hepatitis C, or HIV infection.
- Have had another invasive cancer within the past 3 years.
- Have had a stroke, heart attack, or severe heart problems within 6 months before starting the study.
- Have received radiation therapy within 2 weeks before starting the study.
- Have had major surgery within 4 weeks before starting the study.
- Have severe allergies to any components of enfortumab vedotin.
- Have active eye infections or ulcers.
- Have a history of autoimmune diseases requiring treatment in the past 2 years.
- Have lung diseases like pneumonitis or fibrosis.
- Have had a stem cell or organ transplant.
- Have received a live vaccine within 30 days before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Ironwood Cancer & Research Centers - Chandler | 85224 | Chandler | Arizona |
| Arizona Oncology Associates PD - HOPE | 85710 | Tucson | Arizona |
| Providence St Joseph Medical Center | 91505 | Burbank | California |
| City of Hope National Medical Center | 91010 | Duarte | California |
| University of California Los Angeles Medical Center | 90095 | Los Angeles | California |
| University of California Irvine - Newport | 92868 | Orange | California |
| Rocky Mountain Cancer Centers - Aurora | 80012 | Aurora | Colorado |
| University of Colorado Hospital / University of Colorado | 80045 | Aurora | Colorado |
| Cancer Centers of Colorado - Denver | 80218 | Denver | Colorado |
| Yale Cancer Center | 06520 | New Haven | Connecticut |
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