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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03642067
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : March 16, 2022
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Microsatellite Stable (MSS) Colorectal Adenocarcinomas Colorectal Adenocarcinoma Drug: Nivolumab Drug: Relatlimab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase A Phase 2 Study Evaluating Response and Biomarkers in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer Treated With Nivolumab in Combination With Relatlimab
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort A/B: Nivolumab and Relatlimab
480mg/160mg (co-administered)
 Drug: Nivolumab
Patients will receive treatment every 28 days for up to 2 years. Nivolumab will be administered IV on day 1 (28 day cycle).
Other Name: anti-PD-1, OPDIVO

Drug: Relatlimab
Patients will receive treatment every 28 days up to 2 years. Relatlimab will be administered IV on day 1 (28 day cycle).
Other Name: BMS-986016
Experimental: Cohort C: Nivolumab and Relatlimab
480mg/ 960mg or 480mg/480mg (sequential administration)
 Drug: Nivolumab
Patients will receive treatment every 28 days for up to 2 years. Nivolumab will be administered IV on day 1 (28 day cycle).
Other Name: anti-PD-1, OPDIVO

Drug: Relatlimab
Patients will receive treatment every 28 days up to 2 years. Relatlimab will be administered IV on day 1 (28 day cycle).
Other Name: BMS-986016
Experimental: Cohort C: Nivolumab and Relatlimab (co-administration)
480mg/160mg (co-administration)
 Drug: Nivolumab
Patients will receive treatment every 28 days for up to 2 years. Nivolumab will be administered IV on day 1 (28 day cycle).
Other Name: anti-PD-1, OPDIVO

Drug: Relatlimab
Patients will receive treatment every 28 days up to 2 years. Relatlimab will be administered IV on day 1 (28 day cycle).
Other Name: BMS-986016


Outcome Measures
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Primary Outcome Measures :
  1. Cohort A/B: Objective response rate (ORR) [ Time Frame: 4 years ]
    The proportion of subjects with partial response (PR) or complete response (CR) according to RECIST 1.1.

  2. Cohort C: Objective response rate (ORR) [ Time Frame: 4 years ]
    The proportion of subjects with partial response (PR) or complete response (CR) according to RECIST 1.1.


Secondary Outcome Measures :
  1. Number of participants experiencing study drug-related toxicities [ Time Frame: 4 years ]
    Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years.
  • ECOG performance status 0 or 1
  • Have metastatic or locally advanced microsatellite stable (MSS) colorectal adenocarcinoma.
  • Cohort A: Primary lesion has a composite PD-L1/Mucin (CPM) score ≥ 15%.
  • Cohort B: Primary lesion has a composite PD-L1/Mucin (CPM) score < 15%.
  • Cohort C: Prior surgical resection of primary tumor. Prospective biomarker evaluation not required.
  • Must have received at least one chemotherapy regimen.
  • Patients with the presence of at least one measurable lesion using RECIST 1.1.
  • Patients must have available archival tissue from the surgical resection of their primary tumor.
  • Patient's acceptance of tumor biopsies.
  • Life expectancy of greater than 3 months.
  • Patients must have adequate organ and marrow function defined by study - specified laboratory tests.
  • Documented LVEF ≥ 50% - 6 month prior to drug administration.
  • Must use acceptable form of birth control while on study.
  • Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

  • Known history or evidence of brain metastases. Patients with previously treated brain metastases may participate if they are stable for 4 weeks prior to beginning treatment, have no new or enlarging brain metastases, and are not using steroids for at least 1 week prior to initiation of study treatment.
  • Require any antineoplastic therapy.
  • History of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or anti-Lag-3 antibodies.
  • Had chemotherapy, radiation, or steroids within 14 days prior to study treatment.
  • Had any cytotoxic drug within 4 weeks prior to initiation of study treatment.
  • Hypersensitivity reaction to any monoclonal antibody.
  • Has uncontrolled intercurrent acute or chronic medical illness.
  • Has an active known or suspected autoimmune disease.
  • Has a diagnosis of immunodeficiency.
  • Prior tissue or organ allograft or allogeneic bone marrow transplantation.
  • Requires daily supplemental oxygen
  • History of interstitial lung disease.
  • Requires daily supplemental oxygen.
  • Significant heart disease
  • History of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent.
  • Infection with HIV or hepatitis B or C at screening.
  • Has an active infection.
  • Unable to have blood drawn.
  • Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Woman who are pregnant or breastfeeding.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642067


Contacts
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Contact: Trish Brothers, RN 410-614-3644 GIClinicalTrials@jhmi.edu
Contact: Joann Santmyer, RN 410-614-3644 GIClinicalTrials@jhmi.edu

Locations
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United States, Maryland
Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21231
Contact: Trish Brothers, RN    410-614-3644    GIClinicaltrials@jhmi.edu   
Contact: Joann Santmyer    410-614-3644    GIClinicaltrials@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Bristol-Myers Squibb
Investigators
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Principal Investigator: Dung Le, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
More Information
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03642067    
Other Study ID Numbers: J18119
IRB00173537 ( Other Identifier: JHM IRB )
CA224-068 ( Other Identifier: other )
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: March 16, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Relatlimab
Nivolumab
Immunotherapy
Anti-PD-1
Anti-LAG-3
Antibody
 MSS
PD-L1
Microsatellite stability
Colorectal cancer
Colon cancer
Rectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Adenocarcinoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
 Intestinal Diseases
Rectal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action