Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherap… (NCT04164082) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
United States161 participantsStarted 2020-03-18
Plain-language summary
This phase II trial studies the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Chemotherapy drugs, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to gemcitabine may delay the return of BCG-unresponsive bladder cancer for longer period compared to gemcitabine alone.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* High grade Ta, T1 or CIS urothelial carcinoma. Accrual of patients with Ta or T1 disease may be closed to ensure adequate patients enrollment to meet the primary endpoint
* Persistent disease (defined as not achieving disease free status) after completing therapy with at least induction BCG (\>= 5 doses) and the first round of maintenance or second induction course (\>= 2 doses). The subsequent round of BCG, either maintenance or repeat induction, must be given within 6 months of initial induction BCG
* Persistent high risk NMIBC (T1, high grade Ta and/or CIS) must be within 9 months of the last BCG instillation despite having received adequate BCG as defined above.
* Registration must be within 12 months of last BCG instillation
* High grade T1 after completing therapy with at least induction BCG (\>= 5 doses) or after completing therapy with at least induction BCG (\>= 5 doses) and first round of maintenance or second induction course (\>= 2 doses). The subsequent round of BCG, either maintenance or repeat induction, must be given within 6 months of initial induction BCG
* Disease recurrence (T1) must be within 9 months of the last BCG instillation despite having received adequate BCG as defined above
* Registration must be within 12 months of last BCG instillation
* Mixed variant histology (adenocarcinoma, squamous cell carcinoma) is eligible, but pure variant histology is ineligible
* Patients who are disease free at 6 months after starting …
What they're measuring
1
Complete response rate in the carcinoma in situ (CIS) subpopulation
Timeframe: At 6 months (end of cycle 8, week 25)
2
Event-free survival at 18 months
Timeframe: From the date of study registration to the first documentation of an event or death whichever comes first, assessed up to 18 months