Protocol: ECOG – EAY131-Z1M
Please Note: Below is brief eligibility, for full eligibility requirement’s, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!
- Patients must fulfill all eligibility criteria MATCH Master Protocol.
- Patients must have mismatch repair deficiency based on one of the following: 1. Mismatch repair testing done in any laboratory under CLIA conditions with IHC for MLH1/MSH2 +/-MSH6 +/-PMS2 OR 2. PCR-based microsatellite testing using a validated assay done in any laboratory under CLIA conditions OR 3. A MATCH designated laboratory determination of MMR status by DNA sequencing.
- Patients must have LAG-3 expression at ≥1%.
- Patients with active melanoma are ineligible.
- Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block).
- Patients must have Troponin T (TnT) or I (TnI) <2 x ULN. Patients with TnT or TnI levels between >1 to 2 x ULN will be allowed to register if repeat levels within 24 hours are ≤ 1 x ULN. If TnT or TnI levels are >1 to 2 x ULN within 24 hours, the patients may undergo a cardiac evaluation and be considered for treatment. When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are < 2 x ULN, the patient may undergo cardiac evaluation and be considered for treatment.
- Patients must not have known hypersensitivity to nivolumab and BMS-986016 or compounds of similar chemical or biologic composition.
- Patients must not have received growth factors, including but not limited to granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 2 weeks of study drug administration. Use of such agents while on study is also prohibited. Prior use of growth factors should be documented in the patient’s medical history.
- Patients must not be on supplemental home oxygen.
- Patients must not have prior treatment with anti-LAG3 inhibitors.
- Patients must not have evidence of interstitial lung disease.
- Patients with a requirement for steroid treatment or other immunosuppressive treatment: Patients will be excluded if they have a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement
doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.