Phase 2 Study of Pembrolizumab with Gemcitabine and Cisplatin Before Surgery for Muscle-Invasive Bladder Cancer
Sponsor: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials ID:NCT02690558
This clinical trial is testing whether adding pembrolizumab (Keytruda) to the chemotherapy drugs gemcitabine and cisplatin can help shrink tumors in patients with muscle-invasive bladder cancer before they undergo surgery to remove the bladder.
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Program Overview
The study aims to find out if combining pembrolizumab with gemcitabine and cisplatin can better reduce the size of bladder tumors before surgery in patients with muscle-invasive bladder cancer. Researchers hope this combination will improve treatment outcomes compared to past treatments.
Description
In this study, patients will receive a combination of three drugs: pembrolizumab (Keytruda), gemcitabine, and cisplatin. These drugs will be given in cycles, with each cycle lasting three weeks. On the first day of each cycle, patients will receive all three drugs, and on the eighth day, they will receive gemcitabine and cisplatin. This treatment will continue for four cycles, totaling 12 weeks.
The main goal is to see if this combination can shrink the tumors enough to make them easier to remove during surgery. Researchers will also look at how long patients live without the cancer coming back and overall survival rates. They will monitor the safety of the drug combination and any side effects.
Participants will be followed for five years to track their health and the effectiveness of the treatment. The study will also explore how certain biological markers and cancer subtypes respond to the treatment.
Eligibility Criteria
Inclusion Criteria
- Be 18 years or older.
- Have a confirmed diagnosis of muscle-invasive bladder cancer.
- Have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Be a candidate for bladder removal surgery (cystectomy).
- Have not received prior systemic chemotherapy for bladder cancer.
- Provide tumor tissue samples for research purposes.
- Have adequate organ function based on specific blood tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use two methods of birth control during the study and for 120 days after the last dose.
- Men must agree to use contraception during the study and for 120 days after the last dose.
- Have a life expectancy of more than three months.
- Agree to blood collection for research purposes.
Exclusion Criteria
- Currently participating in another clinical trial or have used an investigational drug or device within four weeks of starting the study.
- Have an immune system deficiency or are taking immunosuppressive drugs.
- Have a history of active tuberculosis.
- Have allergies to pembrolizumab or its ingredients.
- Have had prior treatment with certain antibodies or have not recovered from previous treatments.
- Have another active cancer requiring treatment, except for certain skin cancers or cervical cancer.
- Have an active autoimmune disease requiring treatment in the past two years.
- Have lung disease or active lung inflammation.
- Have an active infection requiring treatment.
- Have a condition that could interfere with the study or is not in the best interest of the participant.
- Have psychiatric or substance abuse issues that could affect participation.
- Are pregnant or breastfeeding, or planning to conceive or father a child during the study and for 120 days after.
- Have received prior therapy targeting specific immune pathways.
- Have received prior radiation therapy to the bladder for bladder cancer.
- Have a history of HIV or active hepatitis B or C.
- Have significant hearing impairment.
- Have received a live vaccine within 30 days before starting the study.
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