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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Advanced or Metastatic Solid Tumors

Treatments: Drug: Cobimetinib; Biological: Nivolumab; Biological: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01928394

CA209-032

2013-002844-10 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

All tumor types are now closed for enrollment:

Triple Negative Breast Cancer

Gastric Cancer

Pancreatic Cancer

Small Cell Lung Cancer

Bladder Cancer

Ovarian Cancer

Enrollment: 1,163 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,163 participants in 6 patient groups

Arm N - Nivolumab

Experimental group

Description:

Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Treatment:

Biological: Nivolumab

Arm N-I, Level 1: Nivolumab+Ipilimumab

Experimental group

Description:

Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 1 mg/kg solution every 3 weeks for 4 doses followed by Nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Treatment:

Biological: Ipilimumab

Biological: Nivolumab

Arm N-I, Level 2: Nivolumab+Ipilimumab

Experimental group

Description:

Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 3 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Treatment:

Biological: Ipilimumab

Biological: Nivolumab

Arm N-I, Level 2b: Nivolumab+Ipilimumab

Experimental group

Description:

Nivolumab 3 mg/kg solution intravenously plus Ipilimumab 1 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Treatment:

Biological: Ipilimumab

Biological: Nivolumab

Arm N-I, Level 2c: Nivolumab+Ipilimumab

Experimental group

Description:

Nivolumab 3 mg/kg solution intravenously every 3 weeks combined with ipilimumab 1 mg/kg every 6 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Treatment:

Biological: Ipilimumab

Biological: Nivolumab

Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib

Experimental group

Description:

Nivolumab 3 mg/kg solution intravenously every 3 weeks combined with ipilimumab 1 mg/kg every 6 weeks and cobimetinib 60mg once daily 21days on/7 days off until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Treatment:

Biological: Ipilimumab

Biological: Nivolumab

Drug: Cobimetinib