A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread

Phase 2

Completed

• Conditions: Microsatellite Stable Colorectal Cancer; Mismatch Repair Proficient Colorectal Cancer; Microsatellite Unstable Colorectal Cancer; Mismatch Repair Deficient Colorectal Cancer
• Interventions: Drug: Ipilimumab; Drug: Nivolumab; Drug: Daratumumab; Drug: BMS-986016; Drug: Cobimetinib

• Registration Number: NCT02060188
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to examine if Nivolumab by itself, or Nivolumab in combination with other anti-cancer drugs, will result in meaningful tumor size reduction, in participants with colon cancer that has come back or has spread, and who have a specific biomarker in their tumors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-18
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-11
• Study Start: 2014-03-12
• Primary Completion: 2024-10-22
• Study Completion: 2024-10-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-16
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 385

Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Histologically confirmed recurrent or metastatic colorectal cancer
• Measurable disease per RECIST v1.1
• Microsatellite instability expression detected by an accredited laboratory
• Participants enrolled into the C3 Cohort must have not had treatment for their metastatic disease

Exclusion Criteria

• Active brain metastases or leptomeningeal metastases are not allowed
• Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
• Prior malignancy active within the previous 3 years except for locally curable cancers
• Participants with active, known or suspected autoimmune disease
• Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration

Other protocol-defined inclusion/exclusion criteria apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nivolumab + Ipilimumab Cohort C3	Nivolumab	-
Nivolumab + Daratumumab Cohort C6	Daratumumab	-
Nivolumab + Ipilimumab Cohort C3	Ipilimumab	-
Nivolumab + BMS-986016 Cohort C5	BMS-986016	-
Nivolumab Monotherapy	Nivolumab	-
Nivolumab + Ipilimumab	Ipilimumab	-
Nivolumab + Ipilimumab	Nivolumab	-
Nivolumab + Ipilimumab + Cobimetinib Cohort C4	Ipilimumab	-
Nivolumab + Ipilimumab + Cobimetinib Cohort C4	Nivolumab	-
Nivolumab + Ipilimumab + Cobimetinib Cohort C4	Cobimetinib	-
Nivolumab + BMS-986016 Cohort C5	Nivolumab	-
Nivolumab + Daratumumab Cohort C6	Nivolumab	-

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator	The final analysis of the primary endpoint will occur at least 6 months after the last enrolled subject's first dose of study therapy (Approximately up to 34 months)

Secondary Outcome Measures

Name	Time	Method
ORR by RECIST v1.1 by Independent Radiology Review Committee (IRRC)	The final analysis of the secondary endpoint will occur the time of the primary endpoint analysis (Approximately up to 34 months)

Trial Locations

Locations (32)

Local Institution - 0028; 🇺🇸 Gilbert, Arizona, United States

Local Institution - 0004; 🇺🇸 Los Angeles, California, United States

Local Institution - 0036; 🇺🇸 Boston, Massachusetts, United States

Local Institution - 0008; 🇺🇸 Atlanta, Georgia, United States

Local Institution - 0013; 🇺🇸 Pittsburgh, Pennsylvania, United States

Local Institution - 0041; 🇺🇸 Allentown, Pennsylvania, United States

Local Institution - 0001; 🇺🇸 San Francisco, California, United States

Local Institution - 0006; 🇺🇸 Nashville, Tennessee, United States

Local Institution - 0034; 🇺🇸 Minneapolis, Minnesota, United States

Local Institution - 0029; 🇺🇸 Winston-Salem, North Carolina, United States

Local Institution - 0024; 🇺🇸 Durham, North Carolina, United States

Local Institution - 0005; 🇺🇸 Portland, Oregon, United States

Local Institution - 0003; 🇺🇸 Houston, Texas, United States

Local Institution - 0019; 🇧🇪 Brussels, Belgium

Local Institution - 0040; 🇦🇺 Westmead, New South Wales, Australia

Local Institution - 0018; 🇧🇪 Brussels, Belgium

Local Institution - 0012; 🇪🇸 Madrid, Spain

Local Institution - 0010; 🇪🇸 Madrid, Spain

Local Institution - 0011; 🇪🇸 Sevilla, Spain

Local Institution - 0027; 🇨🇦 Edmonton, Alberta, Canada

Local Institution - 0020; 🇧🇪 Leuven, Belgium

Local Institution - 0035; 🇮🇹 Modena, Italy

Local Institution - 0032; 🇮🇹 Padova, Italy

Local Institution - 0039; 🇦🇺 Southport, Queensland, Australia

Local Institution - 0022; 🇮🇪 Dublin 4, Ireland

Local Institution - 0030; 🇮🇹 Candiolo, Torino, Italy

Local Institution - 0023; 🇮🇪 Dublin 9, Ireland

Local Institution - 0033; 🇮🇪 Galway, Ireland

Local Institution - 0016; 🇨🇦 Toronto, Ontario, Canada

Local Institution - 0037; 🇦🇺 Melbourne, Victoria, Australia

Local Institution - 0025; 🇫🇷 Paris, France

Local Institution - 0002; 🇺🇸 Boston, Massachusetts, United States