Conditions
Urinary Bladder Neoplasms
Trial Purpose
This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with chemoradiotherapy (CRT) versus CRT alone in participants with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that pembrolizumab + chemoradiotherapy is superior to placebo + chemoradiotherapy with respect to bladder intact event-free survival.
CLINICALTRIALS.GOV IDENTIFIER
NCT04241185
EudraCT Number
2019-004023-20
When you talk with your doctor or clinical trial team member, please have the trial identifier number or the EudraCT number available.
Resources
Eligibility
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
About the trial
Patients who are 18 or older, have an ECOG of 0-2, are clinically diagnosed with MIBC clinical stage T2-T4aN0m0, and are electing bladder preservation, will have an equal chance (similar to flipping a coin) of being assigned to one of two groups.
50% of participants enrolled in the study will receive chemoradiotherapy and pembrolizumab
50% of participants enrolled in the study will receive chemoradiotherapy and placebo
Current 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.
Trial start and end dates
- Trial start date May 19, 2020
- Estimated primary completion date June 10, 2029
- Estimated trial completion date June 10, 2031
Trial locations
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.
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.
Taking part in a clinical trial is an important decision
If you are considering joining a clinical trial, first learn as much as you can about:
- The investigational treatment that is being studied
- What the risks and possible benefits are for participants
Talk to your doctor about the clinical trial before you decide to join.
Read our “What to Consider” page for more questions to ask and think about