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Active, Not Recruiting

A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors - CA209-032

Updated: 7 August, 2020   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1/Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Arm N - Nivolumab
Biological: Nivolumab
Experimental: Arm N-I, Level 1: Nivolumab+Ipilimumab
Experimental: Arm N-I, Level 2: Nivolumab+Ipilimumab
Experimental: Arm N-I, Level 2b: Nivolumab+Ipilimumab
Experimental: Arm N-I, Level 2c: Nivolumab+Ipilimumab
Experimental: Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib

Key Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Subjects with histologically or cytologically confirmed locally advanced or metastatic disease of the following tumor types: - Triple Negative Breast Cancer - Gastric Cancer - Pancreatic Cancer - Small Cell Lung Cancer - Bladder Cancer - Ovarian Cancer - Subjects must have measurable disease - Eastern Cooperative Oncology Group (ECOG) of 0 or 1 - Adequate hematological and organ function as confirmed by laboratory values Exclusion Criteria: - Active brain metastases or leptomeningeal metastases - Subjects with active, known or suspected autoimmune disease - Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment - Prior therapy with experimental anti-tumor vaccines; any T cell co-stimulation or checkpoint pathways, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, including Ipilimumab; or other medicines specifically targeting T cell is also prohibited

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com