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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03106610
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    3 mg/kg of body weight by vein over about 60 minutes on Day 1 of Cycles 1-3.
  • Questionnaires — BEHAVIORAL
    2 quality-of-life questionnaires completed on Day 1 of Cycles 1-3, at the visit before surgery, and 4 weeks after surgery.

Study Details

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.

Key Dates

Start date
Jul 7, 2017
Status verified
May 2018
Primary completion
May 16, 2018
Completion
May 16, 2018

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    Participants receive Nivolumab by vein over about 60 minutes on Day 1 of Cycles 1-3 before scheduled surgery. Each study cycle is 14 days (2 weeks). Questionnaires completed on Day 1 of Cycles 1-3, at the visit before surgery, and 4 weeks after surgery.

Primary Outcome Measure

Safety of Nivolumab in Subjects Previously Treated with Intravesical Bacillus Calmette-Guerin (BCG) Immunotherapy assessed per NCI CTCAE version 4 [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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