Pembrolizumab for Non-Muscle-Invasive Bladder Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Non-Muscle-Invasive Bladder CancerPembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effectiveness of a combination of pembrolizumab and BCG to BCG monotherapy in treating people with high-risk, non-muscle invasive bladder cancer.

Eligible Conditions
  • Non-Muscle-Invasive Bladder Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 18 Secondary · Reporting Duration: Up to ~3.5 years

Year 5
12-Month DOR Rate (Cohorts A and B)
Year 5
12-Month EFS Rate (Cohort A)
Year 5
24-Month EFS Rate (Cohort B)
Year 2
Change from Baseline in EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score (Cohorts A and B)
Change from Baseline in EORTC-QLQ-Non-muscle Invasive Bladder Cancer Module 24 (NMIBC24) Total Score (Cohorts A and B)
Change from Baseline in European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS) (Cohorts A and B)
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score (Cohorts A and B)
Year 2
TTD in the EQ-5D-5L VAS (Cohorts A and B)
Time to Deterioration (TTD) in the EORTC-QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Combined Score (Cohorts A and B)
Up to ~3.5 years
CRR by BICR (Cohort B)
Complete Response Rate (CRR) by Blinded Independent Central Review (BICR) (Cohort A)
Up to ~5 years
Disease Specific Survival (DSS) (Cohorts A and B)
Duration of Response (DOR) (Cohorts A and B)
EFS (Cohort A)
Event-Free Survival (EFS) (Cohort B)
Overall Survival (OS) (Cohorts A and B)
Percentage of Participants Discontinuing Study Drug Due to AEs (Cohorts A and B)
Percentage of Participants Experiencing Adverse Events (AEs) (Cohorts A and B)
Recurrence-Free Survival (RFS) (Cohorts A and B)
Time to Cystectomy (Cohorts A and B)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

5 Treatment Groups

BCG plus Pembrolizumab: BCG Naïve Cohort B-Full Maintenance (Arm B-2)
1 of 5
BCG plus Pembrolizumab: BCG Naïve Cohort B-Reduced Maintenance (Arm B-1)
1 of 5
BCG Monotherapy: BCG Naïve Cohort B (Arm B-3)
1 of 5
BCG plus Pembrolizumab: Post-induction Cohort A (Arm A-1)
1 of 5
BCG Monotherapy: Post-induction Cohort A (Arm A-2)
1 of 5

Experimental Treatment

1405 Total Participants · 5 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 3

BCG plus Pembrolizumab: BCG Naïve Cohort B-Full Maintenance (Arm B-2)Experimental Group · 2 Interventions: Pembrolizumab, BCG · Intervention Types: Biological, Biological
BCG plus Pembrolizumab: BCG Naïve Cohort B-Reduced Maintenance (Arm B-1)Experimental Group · 2 Interventions: Pembrolizumab, BCG · Intervention Types: Biological, Biological
BCG Monotherapy: BCG Naïve Cohort B (Arm B-3)
Biological
Experimental Group · 1 Intervention: BCG · Intervention Types: Biological
BCG plus Pembrolizumab: Post-induction Cohort A (Arm A-1)Experimental Group · 2 Interventions: Pembrolizumab, BCG · Intervention Types: Biological, Biological
BCG Monotherapy: Post-induction Cohort A (Arm A-2)
Biological
Experimental Group · 1 Intervention: BCG · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Bacillus calmette-guerin substrain tice live antigen
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to ~3.5 years

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,684 Previous Clinical Trials
4,956,729 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,576,942 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,640 Previous Clinical Trials
7,940,994 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The tissue has been provided for biomarker analysis.
The text states that there is a locally and independently confirmed histological diagnosis of a high-risk non-muscle invasive bladder cancer.
Cohort A of the BCG post-induction cohort had a statistically significant better 5-year OS than the pre-induction cohort
been associated with increased mortality in cancer patients? A study was conducted to determine if there is a correlation between Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 and increased mortality rates in cancer patients
For the duration of the BCG treatment period and for at least 7 days after the last dose, male participants will either abstain from sex with women as their preferred and usual lifestyle, or else agree to use contraception unless they have been confirmed to be azoospermic.
The individual has been treated with one adequate course of BCG induction therapy for the treatment of HR NMIBC.
After receiving BCG therapy, some people will still have HR NMIBC.
The individual has had a cystoscopy and a transurethral resection of bladder tumor to completely remove any remaining tumor tissue.