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Pembrolizumab + Gemcitabine for Bladder Cancer
Study Summary
This trial is testing whether adding the immunotherapy drug pembrolizumab to the chemotherapy drug gemcitabine can help to treat patients with bladder cancer that has not responded to treatment with Bacillus Calmette-Guerin (BCG).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Group 1: Treatment (pembrolizumab, gemcitabine hydrochloride)
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many sites have been established for this study to be conducted within the state?
"University of California Davis Comprehensive Cancer Center in Sacramento, California, Missouri Baptist Sullivan Hospital in Sullivan, Missouri and Billings Clinic Cancer Center in Billings Arizona are some of the health care centres that are recruiting participants. In total there 100 different sites taking part."
To what conditions is Pembrolizumab commonly prescribed?
"Pembrolizumab is widely used to fight malignant neoplasms and other diseases like inoperable melanoma, microsatellite instability high, and non-small cell lung carcinoma."
Is recruitment still open for this medical experiment?
"Yes, the available data on clinicaltrials.gov indicates that this research endeavour is actively recruiting participants. The trial commenced its recruitment efforts on June 1st 2020 and has since been updated most recently on November 22nd 2022. 161 individuals are required from 100 sites for successful completion of the study."
What is the aim of this medical research project?
"The primary aim of this trial is to assess event-free survival at 18 months, while secondary objectives include assessing recurrence free survival (RFS), duration of response (DOR), and overall survival (OS). RFS will be evaluated using the Kaplan-Meier product-limit estimator, with DOR and OS also being analysed by way of the same methodology. Analyses for these outcomes are expected to occur after 6 months, or approximately 25 weeks into the clinical experiment."
Has Pembrolizumab received authorization from the FDA?
"Although there is some evidence of safety, but no data confirming efficacy, our team at Power assigned Pembrolizumab a score of 2 on the scale from 1 to 3."
What is the current size of enrollment for this clinical trial?
"Affirmative. Information hosted on clinicaltrials.gov supports the notion that this medical study, initially posted on June 1st 2020, is actively enrolling patients. 161 participants need to be recruited from 100 various sites."
Could you provide an overview of the investigations involving Pembrolizumab that have been conducted thus far?
"Presently, there are 1,368 clinical trials utilizing pembrolizumab in some capacity. Of those trials, 244 have advanced to Phase 3 and encompass 54125 different locations with the majority being based out of Shanghai."
Who else is applying?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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