A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Advanced or Metastatic Solid Tumors
Age (in years)
18+
Phase
Phase 1/Phase 2
Participants needed
1163
Est. Completion Date
Dec 31, 2023
Treatment type
Interventional
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov identifier
NCT01928394
Study number
CA209032
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