Conditions
High-risk Non-muscle Invasive Bladder Cancer
Study Overview
Researchers are looking for new ways to treat high-risk non muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment.
The goals of this study are to learn: 1. If more people who receive pembrolizumab with Bacillus Calmette-Guerin (BCG) have no signs of cancer in their body and live longer without the cancer growing, spreading, or coming back compared to people who receive BCG alone. 2. About the safety and how well people tolerate BCG alone or in combination with pembrolizumab.
NATIONAL TRIAL REFERENCE NUMBER
NCT03711032
When you talk with your doctor or clinical team member, please have the national trial reference number available.
Resources
Patient Participation
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.
Age Range
18+
Sex
All
Study Details
Cohort A: All patients who enroll in the trial will receive medication while on the study.
50% of participants will receive BCG+Pembrolizumab
50% of participants will receive BCG only
Cohort B: All patients who enroll in the trial will receive medication while on the study.
33% of participants will receive Pembrolizumab and BCG (reduced BCG course)
33% of participants will receive Pembrolizumab and BCG (full BCG course)
33% of participants will receive BCG alone (full BCG course)
Trial Phase
Trial Phase 3
In Phase 3 trials, researchers try to find out if a treatment works in a large number of people, usually about 1,000 to 5,000 participants who have the health condition the treatment is intended to treat. In vaccine trials, the participants may be healthy or have diseases or conditions. Phase 3 trials may happen in a doctor’s office, a clinic, or a hospital.
Start Date
End Date
- Actual study start date 12-24-2018
- Estimated primary completion date 12-31-2025
- Estimated study completion date 11-20-2034
Trial Locations
Sorry, there are no locations found.
What can you do next?
If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.