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Trial ID CA209-032  |   NCT01928394

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

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Summary

  • Phase 1/Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

To investigate the safety and efficacy of nivolumab as a single agent or in combination with ipilimumab in 6 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), small cell lung cancer (SCLC), bladder cancer (BC), and ovarian cancer (OC). A combination of nivolumab with ipilimumab and cobimetinib is also investigated in PC.

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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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Arm N - Nivolumab

ASSIGNED INTERVENTION
  • Biological: Nivolumab

Study Arms

Experimental: Arm N-I, Level 1: Nivolumab+Ipilimumab

ASSIGNED INTERVENTION

Study Arms

Experimental: Arm N-I, Level 2: Nivolumab+Ipilimumab

ASSIGNED INTERVENTION

Study Arms

Experimental: Arm N-I, Level 2b: Nivolumab+Ipilimumab

ASSIGNED INTERVENTION

Study Arms

Experimental: Arm N-I, Level 2c: Nivolumab+Ipilimumab

ASSIGNED INTERVENTION

Study Arms

Experimental: Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib

ASSIGNED INTERVENTION