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

• Status: Active, not recruiting
• Trial end date: 2022-10-24
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Ipilimumab; Nivolumab

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