Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient (dMMR/MSI-High) Cancers Resistant to Prior PD-L1 Inhibitor
https://www.facingourrisk.org/research-clinical-trials/study/151/nivolumab-and-relatlimab-in-advanced-msi-h-cancers-resistant-to-prior-pd-l1-inhibitor
Clinicaltrials.gov identifier:
NCT03607890 (https://clinicaltrials.gov/show/NCT03607890)
Treatment
Solid tumors that are MSI-High and resistant to prior immunotherapy
Study Contact Information:
Contact: Trish Brothers, RN by phone 410-614-3644 or by email
Contact: Joann Santmyer by phone 410-583-2970 or by email
About the Study
The purpose of this study is to evaluate the safety, effectiveness, and tolerability of using the immunotherapy drugs nivolumab and relatlimab in patients with microsatellite instability high (MSI-H) solid tumors resistant to prior PD-L1 therapy.
Both nivolumab and relatlimab are a type of immunotherapy known as immune checkpoint inhibitors. Immune checkpoint inhibitors are drugs that prevent cancer cells from switching off immune cells. This allows the immune system to find, unmask and destroy cancer cells.
Type of Study
This is an open-label, non-randomized, 2-arm study.
- The study has 2 arms, participants will be placed in one of two groups.
- The study is open-label study, participants will know which group they have been assigned to and which medication they are receiving.
What the Study Entails
Study participants will be placed into one of two groups.
- Group 1: nivolumab and relatlimab will be given together. Patients will receive both drugs intravenously (IV) on day 1 of a 28 day cycle for up to 2 years.
- Group 2: nivolumab and relatlimab will be administered sequentially. Patients will receive one drug therapy first via IV, then will receive the second drug therapy via IV. Drugs will be administered on day 1 of a 28 day cycle for up to 2 years.
Study participants will be followed for 4 years.
This Study is Open To:
Men and women age 18 years and older can be considered for enrollment in this study if they:
- Have metastatic or locally advanced mismatch repair deficient/MSI-H disease.
- Patients must have received prior PD-1/PD-L1 inhibitor therapy
- Patients with at least one measurable lesion.
- Life expectancy greater than 3 months.
This Study is Not Open To:
People with the following are not eligible for this study:
- Evidence of brain metastases.
- Require drug treatment for existing cancer.
- A history of prior treatment with anti-LAG3 therapy
- A hypersensitivity reaction to any monoclonal antibody.
- An autoimmune disease or an immunodeficiency.
- History of lung disease or heart disease
- Infection with HIV, hepatitis B, or hepatitis C.
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.