Trial Watch: Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)
Important context
- Trial eligibility (participation has strict criteria): Clinical-trial participation has study-specific eligibility criteria; registry listing does not mean a person qualifies or should enroll.
In plain English
The 30-second version
What happened?
ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Active Not Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.
Why does it matter?
Phase 3 trials can contribute later-stage human evidence. CancerDiscoveries can track this record as results and regulatory information emerge.
What does this not prove?
A registered trial is not proof that the intervention works, is not FDA approval for this cancer or use, and is not a clinical-guideline recommendation.
Keep reading for evidence stage, limitations, study details, and sources.
What changed: ClinicalTrials.gov lists Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676) (NCT03711032) as a Phase 3 interventional cancer study. The registry status is Active Not Recruiting, with the record last updated 2026-10-23.
Study snapshot: Phase 3; Active Not Recruiting; planned enrollment 1,397. Conditions listed: High-risk Non-muscle Invasive Bladder Cancer. A primary outcome listed by the registry is: Complete Response Rate (CRR) by Blinded Independent Central Review (BICR) (Cohort A).
This entry tracks verified trial-registry facts. Trial registration by itself does not show that an intervention is effective, safe for a particular person, FDA-approved for this use, or recommended by clinical guidelines.
Population / Applicability
Studied in: Participants age 18 Years and older with High-risk Non-muscle Invasive Bladder Cancer who meet the study-specific registry eligibility criteria. (Adults)
Eligibility is study-specific. Registry information does not determine whether any individual should enroll in or receive the intervention.
Full evidence details
- Study design
- Other / not applicable
- Sample size
- 1397
- Primary outcome
- Complete Response Rate (CRR) by Blinded Independent Central Review (BICR) (Cohort A)
- Replication
- Unknown
Funding & Conflicts
ClinicalTrials.gov lists the lead sponsor as Merck Sharp & Dohme LLC. Sponsorship is reported for transparency and does not establish efficacy.
Regulatory status by jurisdiction
Unspecified jurisdiction
- Status
- Investigational
- Last verified
- 2026-10-24
Cancer-type scope for this record is not yet recorded.
Guideline positions
Guideline
- Position
- Not addressed
- Last verified
- 2026-10-24
Primary evidence supporting this story
- ClinicalTrials.gov — NCT03711032 (opens in a new tab) (Clinical-trial registry) NCT03711032 Primary source NCT03711032
ClinicalTrials.gov — NCT03711032. NCT03711032.
Last reviewed
Trial Watch: Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)
https://cancerdiscoveries.com/discoveries/trial-watch-efficacy-and-safety-of-pembrolizumab-mk-3475-in-combination-with-bacillus-calmette-guerin-bcg-in-high-risk-non-muscle-invasive-bladder-cancer-hr-nmibc-mk-3475-676-keynote-676/
Research type: Later-Stage Human
What This Means
ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Active Not Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.
What This Doesn't Mean
A registered trial is not proof that the intervention works, is not FDA approval for this cancer or use, and is not a clinical-guideline recommendation.
Why It Matters
Phase 3 trials can contribute later-stage human evidence. CancerDiscoveries can track this record as results and regulatory information emerge.
Important Limitations
- Clinical-trial participation has study-specific eligibility criteria; registry listing does not mean a person qualifies or should enroll.
Primary sources
- ClinicalTrials.gov — NCT03711032 — https://clinicaltrials.gov/study/NCT03711032 (NCT03711032)
Date verified: 2026-10-24
Correction status: No correction or retraction