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

Status: Closed to Accrual


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.

Eligibility Criteria

Inclusion Criteria

  • Subjects with histologically 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

Locations & Contacts


New Haven
Yale University
Status: Active
Contact: Joseph Paul Eder
Phone: 203-785-5702
Email: joseph.eder@yale.edu


Dana-Farber Cancer Institute
Status: Active
Contact: Patrick Alexander Ott
Phone: 617-582-9030
Email: patrick_ott@dfci.harvard.edu

North Carolina

Duke University Medical Center
Status: Active
Contact: Michael A. Morse
Phone: 888-275-3853

Trial Objectives and Outline

All tumor types are now closed for enrollment: Triple Negative Breast Cancer Gastric Cancer Pancreatic Cancer Small Cell Lung Cancer Bladder Cancer Ovarian Cancer

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type


Lead Organization

Lead Organization
Bristol-Myers Squibb

Trial IDs

Primary ID CA209-032
Secondary IDs NCI-2013-02337, 2013-002844-10
Clinicaltrials.gov ID NCT01928394