Study on Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab for Treating Localized Muscle-invasive Bladder Cancer
Sponsor: Columbia University
ClinicalTrials ID:NCT06571708
This clinical trial is testing whether a combination of chemotherapy drugs gemcitabine and cisplatin, along with the immunotherapy drug cemiplimab, with or without another drug called fianlimab, can effectively treat bladder cancer in adults.
Patient Parameters
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Program Overview
The purpose of this study is to find out if using a combination of chemotherapy drugs (gemcitabine and cisplatin) and an immunotherapy drug (cemiplimab), with or without an additional drug (fianlimab), can help treat bladder cancer that has invaded the muscle. Participants will be randomly assigned to receive either the combination with fianlimab or without it. The treatment involves four cycles of chemotherapy and immunotherapy, followed by surgery to check the response. If the cancer responds well, participants will continue with maintenance therapy for up to 13 more cycles. If the cancer does not respond completely, surgery to remove the bladder may be necessary.
Description
This study is a phase 2 trial that looks at the safety and effectiveness of combining chemotherapy (gemcitabine and cisplatin) with an immunotherapy drug (cemiplimab), with or without another drug (fianlimab), for treating muscle-invasive bladder cancer. Participants will be randomly assigned to receive either the combination with fianlimab or without it. The treatment consists of four cycles, each lasting three weeks, followed by surgery to assess the cancer's response. If the cancer is completely gone, participants will continue with maintenance therapy for up to 13 more cycles. If the cancer is not completely gone, surgery to remove the bladder may be necessary. Throughout the study, participants will have regular check-ups, including scans and lab tests, to monitor their health and the treatment's effects.
Eligibility Criteria
Inclusion Criteria
- Must be willing and able to provide written consent to participate.
- Must be 18 years or older.
- Must have a life expectancy of more than 12 months.
- Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Must have a confirmed diagnosis of muscle-invasive bladder cancer, specifically stages T2-T3, N0, M0.
- Previous treatment with BCG or other bladder treatments is allowed if completed at least 6 weeks before starting the study.
- Must not have any signs of cancer spread based on imaging tests.
- Must be eligible to receive cisplatin based on specific criteria.
- Must not have received any prior chemotherapy or immunotherapy for muscle-invasive bladder cancer.
- Must agree to undergo specific procedures and follow-up tests as part of the study.
Exclusion Criteria
- Cannot have invasive bladder cancer in the upper urinary tract.
- Cannot have received prior immune checkpoint inhibitors or certain other cancer treatments.
- Cannot have had previous radiation therapy directed at the bladder.
- Cannot have received prior chemotherapy for muscle-invasive bladder cancer.
- Cannot be participating in another clinical trial or taking investigational drugs.
- Cannot have had a solid organ or blood cell transplant.
- Cannot have an autoimmune disease requiring treatment in the past two years, except for certain conditions like vitiligo or controlled hypothyroidism.
- Cannot have a history of myocarditis.
- Cannot have another active cancer, except for certain skin cancers.
- Cannot have lung disease or active lung inflammation.
- Cannot have an active infection requiring treatment.
- Cannot have significant infections or conditions that could interfere with the study.
- Cannot have uncontrolled HIV, hepatitis B, or hepatitis C infections.
- Cannot be pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Columbia University Irving Medical Center | 10032 | New York | New York |
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