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Pembrolizumab and BCG Solution in Treating Patients With Recurrent Non-Muscle-Invasive Bladder Cancer

NCT02808143 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-06-26

Study results available
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Summary

The purpose of this study is to evaluate the efficacy (the effect of drug on tumor) and the tolerability (the effect of drug on the body) of pembrolizumab, when given as a single agent in patients with bladder tumors. Another purpose of the study is to see what tumor characteristics are associated with increased efficacy of the pembrolizumab. Pembrolizumab (MK-3475) is an antibody (a human protein that sticks to a part of the tumor and/or immune cells) designed to allow the body's immune system to work against tumor cells. Pembrolizumab is Food and drug Administration (FDA) approved for the treatment of advanced melanoma (a type of skin cancer) and some types of lung cancer. It is not yet approved by the United States Food and Drug Administration (USFDA) for bladder cancer, hence it is considered an investigational agent for this disease.

Conditions

  • Recurrent Bladder Carcinoma
  • Stage 0a Bladder Urothelial Carcinoma
  • Stage 0is Bladder Urothelial Carcinoma
  • Stage I Bladder Cancer

Interventions

BIOLOGICAL

BCG Solution

Given intravesically

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Pembrolizumab

Given intravesically

OTHER

Pharmacological Study

Correlative studies

Sponsors & Collaborators

Principal Investigators

  • Joshua Meeks · Northwestern University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-10
Primary Completion
2020-05-15
Completion
2022-08-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02808143 on ClinicalTrials.gov