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Trial record 7 of 17 for:    BMS-986016

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

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ClinicalTrials.gov Identifier: NCT03642067
Recruitment Status : Not yet recruiting
First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Intervention Model: Single Group 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
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

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

Drug: Relatlimab
Relatlimab (160 mg) will be administered IV on day 1 (28 day cycle).
Other Name: BMS-986016




Primary Outcome Measures :
  1. 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

  2. Overall survival (OS) [ Time Frame: 4 years ]
    Number of months from the date of first treatment until death or end of follow-up.

  3. Progression free survival (PFS) [ Time Frame: 4 years ]
    Number of months from treatment to disease progression (PD) or relapse from complete response (CR) as assessed using RECIST 1.1 criteria, or death due to any cause.

  4. Time to Progression (TTP) [ Time Frame: 4 years ]
    Number of months from the date of first treatment to the date of documented disease progression (PD or relapse from CR as assessed using RECIST 1.1 criteria).

  5. Disease control rate (DCR) [ Time Frame: 4 years ]
    Percentage of participants achieving stable disease (SD) or better (SD + partial response (PR) + CR).

  6. Best overall response (BOR) [ Time Frame: 4 years ]
    Best response recorded from the start of the treatment until disease progression/recurrence per RECIST 1.1 criteria.

  7. Duration of response (DOR) [ Time Frame: 4 years ]
    Number of months from the first documentation of a response to date of disease progression.

  8. Duration of clinical benefit (DCB) [ Time Frame: 4 years ]
    Number of months from the date of first treatment to date of disease progression in those achieving a PR or CR.

  9. Time to objective response (TTOR) [ Time Frame: 4 years ]
    Number of months from the date of first treatment to the date of documented partial or complete response.



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Ages Eligible for Study:   18 Years to 100 Years   (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.
  • 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.
  • 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.
  • 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.
  • 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.

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
Contact: Susan Sartorius-Mergenthaler, RN 410-614-3644 Sartosu@jhmi.edu
Contact: Jane Zorzi, RN 410-614-5818 Jzorzi1@jhmi.edu

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Bristol-Myers Squibb
Investigators
Principal Investigator: Dung Le, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03642067     History of Changes
Other Study ID Numbers: J18119
IRB00173537, CA224-068 ( Other Identifier: Johns Hopkins Medical Institution )
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
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
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs