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

Trial 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.

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

Colorado

Aurora
University of Colorado Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Jennifer Robinson Diamond
Phone: 720-848-0650

Connecticut

New Haven
Yale University
Status: ACTIVE
Contact: Joseph Paul Eder
Phone: 203-785-5702

Florida

Tampa
Moffitt Cancer Center
Status: CLOSED_TO_ACCRUAL

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Rathi Narayana Pillai
Phone: 404-778-1868

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Dung Thi Le
Phone: 410-955-8866

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Patrick Alexander Ott
Phone: 617-582-9030
Massachusetts General Hospital Cancer Center
Status: CLOSED_TO_ACCRUAL

New York

New York
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Margaret Kathleen Callahan
Phone: 212-639-7202

North Carolina

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

Oregon

Portland
OHSU Knight Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Matthew Hiram Taylor
Phone: 503-494-6594

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: CLOSED_TO_ACCRUAL

Texas

Houston
M D Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL

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 Phase I/II

Trial Type Treatment

Lead Organization
Bristol-Myers Squibb

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