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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT03642067
Phase
PHASE2
Status
Completed

Conditions

  • Colorectal Adenocarcinoma
  • Microsatellite Stable (MSS) Colorectal Adenocarcinomas

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab was administered IV on day 1 of each 28 day cycle.
  • Relatlimab — DRUG
    Relatlimab was administered IV on day 1 of each 28 day cycle.

Study Details

The purpose of this study is to evaluate the safety and clinical activity of nivolumab and relatlimab in patients with metastatic or locally advanced microsatellite stable (MSS) colorectal cancer.

Key Dates

Start date
Feb 12, 2019
Status verified
Jun 2025
Primary completion
Feb 23, 2024
Completion
Sep 18, 2024

Study Design

Enrollment
59 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.
  • 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.
  • 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).

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231-

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By research site
Sidney Kimmel Comprehensive Cancer Center· Baltimore, MD

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