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Title:
J18102 - Phase 2 Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibition
Protocol Number:
J18102
Phase:
Phase II
Physician:
Dung Le
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
The purpose of this study is to assess the safety and clinical activity of nivolumab and relatlimab in people with advanced cancer that is microsatellite instability high (MSI-H), and whose cancer has grown on a previous immunotherapy.
Eligibility:
The patient must be 18 years or older, have a metastatic or locally advanced mismatch repair deficient/MSI-H solid tumor malignancy, and have progressed on prior PD-1/PD-L1 immunotherapy. The patient must have an ECOG of 0, normal activity, or 1, symptomatic but ambulatory. The patient must be willing to have a biopsy at baseline and on treatment. The patient must have a life expectancy of greater than 3 months, have normal organ and marrow function, and have good heart health. Patients cannot be pregnant or nursing and must be willing to follow contraception guidelines. The patient must not have any active central nervous system metastases, require any antineoplastic therapy, or have a history of prior anti-LAG3. Within two weeks of starting treatment, the patient must not have received systemic steroid therapy, chemotherapy, or radiation. Within four weeks of the starting treatment, the patient must not have received any other investigational drug, live vaccines, allergy shots, growth factors, or major surgery. Patients must not use illicit drugs, have a recent history of substance abuse, or require daily supplemental oxygen. Patients must not have a known or suspected autoimmune disease, a history of interstitial lung disease, or any other condition that could make it dangerous or difficult for the patient to receive the study drug and comply with the study.
Treatment:
All eligible patients who participate in this study will receive nivolumab and relatlimab through an IV on day 1 of each 28-day cycle for a maximum of 2 years.
Population:
Adult
Last Update
03/05/2019 05:03 AM