A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) and Pembrolizumab in Combination with Other Investigational Agents in Subjects with High-risk Non-muscle-Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502526-41-00

Acronym

MK-3475-057

Enrollment

102

Registered

2023-07-13

Start date

2016-03-15

Completion date

2025-11-05

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Muscle Invasive Bladder Cancer (NMIBC)

Brief summary

Cohort A: Complete Response (CR) Rate of High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC), Cohort B: 12-month Disease-Free Survival (DFS) Rate of High-Risk NMIBC, Cohort A and B: Number of Participants Who Experience an Adverse Event (AE), Cohort A and B: Number of Participants Who Discontinue Study Treatment Due to an AE

Detailed description

Cohort A: CR Rate of Any Disease, Cohort A: CR Rate of High-Risk NMIBC in Programmed Cell Death 1 (PDL-1) Positive Participants, Cohort A: Duration of Response (DOR), Cohort A and B: Progression-Free Survival (PFS), Cohort A and B: Overall Survival (OS), Cohort B: DFS Rate of Any Disease, Cohort B: 12-month DFS Rate of Any Disease, Cohort B: 12-month DFS Rate of High-Risk NMIBC in PDL-1 Positive Participants

Interventions

DRUGMK-7684A

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGMK-4280A

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Cohort A: Complete Response (CR) Rate of High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC), Cohort B: 12-month Disease-Free Survival (DFS) Rate of High-Risk NMIBC, Cohort A and B: Number of Participants Who Experience an Adverse Event (AE), Cohort A and B: Number of Participants Who Discontinue Study Treatment Due to an AE	—

Secondary

Measure	Time frame
Cohort A: CR Rate of Any Disease, Cohort A: CR Rate of High-Risk NMIBC in Programmed Cell Death 1 (PDL-1) Positive Participants, Cohort A: Duration of Response (DOR), Cohort A and B: Progression-Free Survival (PFS), Cohort A and B: Overall Survival (OS), Cohort B: DFS Rate of Any Disease, Cohort B: 12-month DFS Rate of Any Disease, Cohort B: 12-month DFS Rate of High-Risk NMIBC in PDL-1 Positive Participants	—

Measure

Time frame

—

Countries

Finland, France, Greece, Italy, Netherlands, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026