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Trial record 9 of 18 for:    BMS-986016

Phase 2 Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor

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ClinicalTrials.gov Identifier: NCT03607890
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : November 8, 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 microsatellite instability high (MSI-H) solid tumors refractory to prior PD-(L)1 therapy.

Condition or disease Intervention/treatment Phase
Refractory MSI - H Solid Tumors Prior of PD-(L) 1 Therapy MSI-H Tumors Drug: Nivolumab Drug: Relatlimab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor
Actual Study Start Date : November 6, 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 Drug: Nivolumab
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).
Other Name: anti-PD-1, OPDIVO

Drug: Relatlimab
Patients will receive treatment every 28 days up to 2 years. 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) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Number of participants experiencing study drug-related toxicities [ Time Frame: 4 years ]
  2. Overall survival (OS) using RECIST 1.1 [ Time Frame: 4 years ]
  3. Progression free survival (PFS) using RECIST 1.1 [ Time Frame: 4 years ]
  4. Disease control rate (DCR) using RECIST 1.1 [ Time Frame: 4 years ]
  5. Best overall response (BOR) using RECIST 1.1 [ Time Frame: 4 years ]
  6. Duration of response (DOR) using RECIST 1.1 [ Time Frame: 4 years ]
  7. Duration of clinical benefit (DCB) using RECIST 1.1 [ Time Frame: 4 years ]
  8. Time to objective response (TTOR) using RECIST 1.1 [ Time Frame: 4 years ]


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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.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Have metastatic or locally advanced mismatch repair deficient/MSI-H disease.
  • Patients must have received prior PD-1/PD-L1 inhibitor therapy
  • Have disease progression.
  • Patients with the presence of at least one measurable lesion.
  • Life expectancy of greater than 3 months.
  • Patients must have adequate organ and marrow function defined by study - specified laboratory tests.
  • Documented left ventricular ejection fraction (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-LAG3.
  • Had chemotherapy, radiation, or steroids within 14 days prior to study treatment.
  • Have received any investigational drugs, a live vaccine, any allergen hyposensitization therapy, growth factors or major surgery within 28 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.
  • Prior life-threatening toxicity to anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-CTLA4
  • 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): NCT03607890


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 Recruiting
Baltimore, Maryland, United States, 21231
Contact: Susan Sartorius-Mergenthaler, RN    410-614-3644    Sartosu@jhmi.edu   
Contact: Jane Zorzi, RN    410-614-5818    Jzorzi1@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Bristol-Myers Squibb
Investigators
Principal Investigator: Dung Le, MD Johns Hopkins Medical Institution

Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03607890     History of Changes
Other Study ID Numbers: J18102
IRB00173534 ( Other Identifier: Johns Hopkins Medical Insitution )
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 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
Antibodies
MSI
MMR deficient
Microsatellite instability

Additional relevant MeSH terms:
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs