Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer

Browse trials for

• Colorectal Neoplasms 5,598
• Adenocarcinoma 2,004

Keywords

• Relatlimab
• Nivolumab
• Immunotherapy
• Anti-PD-1
• Anti-LAG-3
• Antibody
• MSS
• PD-L1
• Microsatellite stability
• Colorectal cancer
• Colon cancer
• Rectal cancer

Colorectal Neoplasms

5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

This study's enrollment of 59 is below the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 67 (60%) have results posted.

Study arms

• Experimental
  Cohort A: Composite PD-L1/Mucin (CPM) positive colorectal cancer

  Participants were pre-screened for CPM score. The CPM score integrates the percent of PD-L1 expression at the tumor interface and the percent of acellular mucin in the tumor area (\[%PD-L1 + % acellular mucin\]/2) using each participant's primary tumor tissue. A CPM score cutoff of greater than or equal to 15% was used to determine CPM positivity. Participants received 480mg Nivolumab and 160mg Relatlimab.

  Drug: Nivolumab · Drug: Relatlimab

• Experimental
  Cohort B: Composite PD-L1/Mucin (CPM) negative colorectal cancer

  Participants were pre-screened for CPM score. The CPM score integrates the percent of PD-L1 expression at the tumor interface and the percent of acellular mucin in the tumor area (\[%PD-L1 + % acellular mucin\]/2) using each participant's primary tumor tissue. A CPM score cutoff of less than 15% was used to determine CPM negativity. Participants received 480mg Nivolumab and 160mg Relatlimab.

  Drug: Nivolumab · Drug: Relatlimab

• Experimental
  Cohort C: Colorectal cancer with no biomarker evaluation required

  Participants were not pre-screened for composite PD-L1/mucin (CPM) score. Participants received 480mg Nivolumab and 960mg Relatlimab (dose reduced to 480mg or 160mg).

  Drug: Nivolumab · Drug: Relatlimab

Interventions

• DrugNivolumab

  Nivolumab was administered IV on day 1 of each 28 day cycle.

  Also known as: OPDIVO, BMS-936558, anti-PD-1

• DrugRelatlimab

  Relatlimab was administered IV on day 1 of each 28 day cycle.

  Also known as: BMS-986016, anti-LAG-3

Primary outcomes

1. Objective Response Rate (ORR)

   ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions. Participants who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders. Participants who discontinue for other reasons prior to their first dose of study drug will not included in the analysis.

   Time frame: 12 months

Secondary outcomes

1. Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation

   Defined using NCI CTCAE v5.0

   Time frame: 12 months

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Mar 31, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided