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A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread (CheckMate142)

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Active, not recruiting
Phase 2

Conditions

Microsatellite Unstable Colorectal Cancer
Microsatellite Stable Colorectal Cancer
Mismatch Repair Proficient Colorectal Cancer
Mismatch Repair Deficient Colorectal Cancer

Treatments

Drug: Ipilimumab
Drug: Daratumumab
Drug: Cobimetinib
Drug: Nivolumab
Drug: BMS-986016

Study type

Interventional

Funder types

Industry

Identifiers

NCT02060188
CA209-142
2013-003939-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

385 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

385 participants in 6 patient groups

Nivolumab Monotherapy
Experimental group
Treatment:
Drug: Nivolumab
Nivolumab + Ipilimumab
Experimental group
Treatment:
Drug: Nivolumab
Drug: Ipilimumab
Nivolumab + Ipilimumab Cohort C3
Experimental group
Treatment:
Drug: Nivolumab
Drug: Ipilimumab
Nivolumab + Ipilimumab + Cobimetinib Cohort C4
Experimental group
Treatment:
Drug: Nivolumab
Drug: Cobimetinib
Drug: Ipilimumab
Nivolumab + BMS-986016 Cohort C5
Experimental group
Treatment:
Drug: BMS-986016
Drug: Nivolumab
Nivolumab + Daratumumab Cohort C6
Experimental group
Treatment:
Drug: Nivolumab
Drug: Daratumumab

Trial contacts and locations

33

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Data sourced from clinicaltrials.gov

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