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Trial of Anti-PD-1 (Nivolumab) in Bladder Cancer Patients Recently Treated With Intravesical BCG Immunotherapy

NCT03106610 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2018-05-24

No results posted yet for this study

Summary

The goal of this clinical research study is to learn about the tolerability of nivolumab in patients who have bladder cancer, were previously treated with BCG immunotherapy, and who have a cystectomy (removal of all or part of the bladder) scheduled as part of their standard care.

This is an investigational study. Nivolumab is FDA approved and commercially available to treat metastatic (has spread) melanoma or non-small cell lung cancer (NSCLC) after the disease has gotten worse while receiving platinum-based chemotherapy. The use of nivolumab in this study is considered investigational.

Up to 10 participants will take part in this study. All will be enrolled at MD Anderson.

Conditions

Interventions

DRUG

Nivolumab

3 mg/kg of body weight by vein over about 60 minutes on Day 1 of Cycles 1-3.

BEHAVIORAL

Questionnaires

2 quality-of-life questionnaires completed on Day 1 of Cycles 1-3, at the visit before surgery, and 4 weeks after surgery.

Sponsors & Collaborators

Principal Investigators

  • Matthew Campbell, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-07
Primary Completion
2018-05-16
Completion
2018-05-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT03106610 on ClinicalTrials.gov