Conditions
High-risk Non-muscle Invasive Bladder Cancer
Trial Purpose
This study is designed to assess the antitumour efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction (Cohort A) or that is naïve to BCG treatment (Cohort B). The primary hypothesis for Cohort A is that the combination of pembrolizumab plus BCG has a superior complete response rate (CRR) as assessed by central pathology review compared to BCG in participants with carcinoma in situ (CIS). The primary hypothesis for Cohort B is that the combination of pembrolizumab plus BCG (either reduced maintenance or full maintenance) has a superior Event Free Survival (EFS) compared to BCG.
NATIONAL TRIAL REFERENCE NUMBER
NCT03711032
EudraCT
2018-001967-22
When speaking to your doctor or clinical trial representative, please have the trial reference 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
All patients who enrol in the trial will receive medication while on the study.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
Tests the medicine or vaccine in large groups of trial participants (from several hundred to several thousand). For medicines, volunteers have the disease or condition the medicine is designed to treat. In vaccine studies, the volunteers may be healthy or have diseases or conditions. Phase 3 trials take place in hospitals, clinics or doctors’ offices.
Trial start and end dates
- Actual study start date 24 December 2018
- Estimated primary completion date 31 December 2025
- Estimated study completion date 12 October 2028
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