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

Completed · Phase 1/Phase 2

Conditions studied: Advanced or Metastatic Solid Tumors

In brief

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.

Key facts

Study ID

NCT01928394

Run by

Bristol-Myers Squibb

People needed

1163

Starts

2013-10-24

Expected to finish

2024-11-18

Last updated by the study team

2024-12-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 0047 — Muscle Shoals, Alabama, United States
• Local Institution - 0044 — Aurora, Colorado, United States
• Local Institution - 0015 — New Haven, Connecticut, United States
• Local Institution - 0046 — Gainesville, Florida, United States
• Local Institution - 0021 — Tampa, Florida, United States
• Local Institution - 0001 — Atlanta, Georgia, United States
• Local Institution - 0004 — Baltimore, Maryland, United States
• Local Institution - 0005 — Boston, Massachusetts, United States
• Local Institution - 0043 — Boston, Massachusetts, United States
• Local Institution - 0049 — Omaha, Nebraska, United States
• Local Institution - 0045 — Mineola, New York, United States
• Local Institution - 0006 — New York, New York, United States
• Local Institution - 0003 — Charlotte, North Carolina, United States
• Local Institution - 0008 — Durham, North Carolina, United States
• Local Institution - 0007 — Portland, Oregon, United States
• Local Institution - 0011 — Franklin, Tennessee, United States
• Local Institution - 0002 — Nashville, Tennessee, United States
• Local Institution - 0009 — Houston, Texas, United States
• Local Institution - 0042 — Seattle, Washington, United States
• Local Institution - 0038 — Toronto, Ontario, Canada
• Local Institution - 0039 — Copenhagen, Denmark
• Local Institution - 0014 — Helsinki, Uusimaa, Finland
• Local Institution - 0036 — Tampere, Finland
• Local Institution - 0048 — Bonn, Germany
• Local Institution - 0026 — Frankfurt, Germany

Full record on ClinicalTrials.gov

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