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

• ClinicalTrials.gov Identifier: NCT02060188
• Recruitment Status: Active, not recruiting
• First Posted: February 11, 2014
• Last Update Posted: May 10, 2024
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Tracking Information

• First Submitted Date: December 18, 2013
• First Posted Date: February 11, 2014
• Last Update Posted Date: May 10, 2024
• Actual Study Start Date: March 12, 2014
• Estimated Primary Completion Date: June 28, 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 21, 2021): Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator [ Time Frame: 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) ]

Original Primary Outcome Measures (submitted: February 10, 2014)

Objective response rate (ORR) in all MSI-High subjects as determined by Investigators [ Time Frame: 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) ]

(Tumor imaging assessments will occur every 6 weeks from the date of first dose (+/-1 wk) for the first 24 weeks, then every 12 wks (+/- 1 wk) thereafter until disease progression or treatment is discontinued (whichever occurs later)) (Tumor imaging assessments will occur every 6 weeks from the date of first dose (+/-1 wk) for the first 24 weeks, then every 12 wks (+/- 1 wk) thereafter until disease progression or treatment is discontinued (whichever occurs later))

• Current Secondary Outcome Measures (submitted: December 21, 2021): ORR by RECIST v1.1 by Independent Radiology Review Committee (IRRC) [ Time Frame: The final analysis of the secondary endpoint will occur the time of the primary endpoint analysis (Approximately up to 34 months) ]

Original Secondary Outcome Measures (submitted: February 10, 2014)

ORR in all MSI-H subjects based on IRRC determination [ Time Frame: The final analysis of the secondary endpoint will occur the time of the primary endpoint analysis (Approximately up to 34 months) ]

Tumor imaging assessments will occur every 6 weeks from the date of first dose (+/- wk) for the first 24 weeks, then every 12 wks (+/- 1 wk) thereafter until disease progression or treatment is discontinued(whichever occurs later)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread
• Official Title: A Phase 2 Clinical Trial of Nivolumab, or Nivolumab Combinations in Recurrent and Metastatic Microsatellite Instability High (MSI-H) and Non-MSI-H Colon Cancer
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

• Drug: Ipilimumab
  Specified dose on specified days
  Other Name: Yervoy
• Drug: Nivolumab
  Specified dose on specified days
  Other Names:

  • BMS-936558
  • Opdivo
• Drug: Cobimetinib
  Specified dose on specified days
  Other Name: Cotellic
• Drug: Daratumumab
  Specified dose on specified days
  Other Name: Darzalex
• Drug: BMS-986016
  Specified dose on specified days

Study Arms

• Experimental: Nivolumab Monotherapy
  Intervention: Drug: Nivolumab
• Experimental: Nivolumab + Ipilimumab
  Interventions:

  • Drug: Ipilimumab
  • Drug: Nivolumab
• Experimental: Nivolumab + Ipilimumab Cohort C3
  Interventions:

  • Drug: Ipilimumab
  • Drug: Nivolumab
• Experimental: Nivolumab + Ipilimumab + Cobimetinib Cohort C4
  Interventions:

  • Drug: Ipilimumab
  • Drug: Nivolumab
  • Drug: Cobimetinib
• Experimental: Nivolumab + BMS-986016 Cohort C5
  Interventions:

  • Drug: Nivolumab
  • Drug: BMS-986016
• Experimental: Nivolumab + Daratumumab Cohort C6
  Interventions:

  • Drug: Nivolumab
  • Drug: Daratumumab

Publications *

• Lenz HJ, Van Cutsem E, Luisa Limon M, Wong KYM, Hendlisz A, Aglietta M, Garcia-Alfonso P, Neyns B, Luppi G, Cardin DB, Dragovich T, Shah U, Abdullaev S, Gricar J, Ledeine JM, Overman MJ, Lonardi S. First-Line Nivolumab Plus Low-Dose Ipilimumab for Microsatellite Instability-High/Mismatch Repair-Deficient Metastatic Colorectal Cancer: The Phase II CheckMate 142 Study. J Clin Oncol. 2022 Jan 10;40(2):161-170. doi: 10.1200/JCO.21.01015. Epub 2021 Oct 12.
• Overman MJ, Lonardi S, Wong KYM, Lenz HJ, Gelsomino F, Aglietta M, Morse MA, Van Cutsem E, McDermott R, Hill A, Sawyer MB, Hendlisz A, Neyns B, Svrcek M, Moss RA, Ledeine JM, Cao ZA, Kamble S, Kopetz S, Andre T. Durable Clinical Benefit With Nivolumab Plus Ipilimumab in DNA Mismatch Repair-Deficient/Microsatellite Instability-High Metastatic Colorectal Cancer. J Clin Oncol. 2018 Mar 10;36(8):773-779. doi: 10.1200/JCO.2017.76.9901. Epub 2018 Jan 20.
• Overman MJ, McDermott R, Leach JL, Lonardi S, Lenz HJ, Morse MA, Desai J, Hill A, Axelson M, Moss RA, Goldberg MV, Cao ZA, Ledeine JM, Maglinte GA, Kopetz S, Andre T. Nivolumab in patients with metastatic DNA mismatch repair-deficient or microsatellite instability-high colorectal cancer (CheckMate 142): an open-label, multicentre, phase 2 study. Lancet Oncol. 2017 Sep;18(9):1182-1191. doi: 10.1016/S1470-2045(17)30422-9. Epub 2017 Jul 19. Erratum In: Lancet Oncol. 2017 Sep;18(9):e510.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: October 13, 2021): 385
• Original Estimated Enrollment (submitted: February 10, 2014): 96
• Estimated Study Completion Date: June 28, 2024
• Estimated Primary Completion Date: June 28, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Belgium, Canada, France, Ireland, Italy, Spain, United States

Administrative Information

• NCT Number: NCT02060188
• Other Study ID Numbers: CA209-142; 2013-003939-30 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Bristol-Myers Squibb
• Original Responsible Party: Same as current
• Current Study Sponsor: Bristol-Myers Squibb
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: May 2024