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

Phase 1

Completed

• Conditions: Advanced or Metastatic Solid Tumors
• Interventions: Biological: Nivolumab; Biological: Ipilimumab; Drug: Cobimetinib

• Registration Number: NCT01928394
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2013-08-21
• Study First Submitted QC: 2013-08-21
• Study First Posted: 2013-08-23
• Study Start: 2013-10-24
• Primary Completion: 2019-02-05
• Results First Submitted: 2020-02-05
• Results First Submitted QC: 2020-03-12
• Results First Posted: 2020-03-24
• Study Completion: 2024-11-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1163

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm N-I, Level 2c: Nivolumab+Ipilimumab	Ipilimumab	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
Arm N - Nivolumab	Nivolumab	Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Arm N-I, Level 1: Nivolumab+Ipilimumab	Ipilimumab	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
Arm N-I, Level 1: Nivolumab+Ipilimumab	Nivolumab	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
Arm N-I, Level 2b: Nivolumab+Ipilimumab	Ipilimumab	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
Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib	Nivolumab	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
Arm N-I, Level 2: Nivolumab+Ipilimumab	Nivolumab	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
Arm N-I, Level 2: Nivolumab+Ipilimumab	Ipilimumab	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
Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib	Cobimetinib	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
Arm N-I, Level 2b: Nivolumab+Ipilimumab	Nivolumab	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
Arm N-I, Level 2c: Nivolumab+Ipilimumab	Nivolumab	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
Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib	Ipilimumab	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

Primary Outcome Measures

Name	Time	Method
Objective Response Rate ( ORR )	60 months	The number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants.

Trial Locations

Locations (38)

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

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