Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorecta… (NCT03642067) | Clinical Trial Compass
CompletedPhase 2
Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer
United States59 participantsStarted 2019-02-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: 12 months
Trial details
NCT IDNCT03642067
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins