Nivolumab Plus Relatlimab in Patients With Metastatic Uveal Melanoma

Exclusion Criteria

• •1. Are currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 3 weeks of the first dose of treatment.
• •2. Have a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Patients on replacement doses of corticosteroids and patients who received steroids as pre-medication to prevent an imaging contrast allergy are allowed.
• •3. Have a known history of active tuberculosis (Bacillus Tuberculosis)
• •4. Have had prior treatment with a PD-1 and/or LAG-3 targeted agent
• •5. Have hypersensitivity to nivolumab, relatlimab or any of their excipients.
• •6. Have had a prior anti-cancer monoclonal antibody (mAb) within 3 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from clinically significant adverse events due to agents administered more than 3 weeks earlier.
• •7. Have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 3 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from clinically significant adverse events due to a previously administered agent.
• •* Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
• •* Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
• •* Note: Patients will be allowed necessary and palliative radiation therapy to limited fields during the trial, as long as it does not encompass a target lesion.
• •8. Have a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma or squamous cell carcinoma of the skin that has undergone potentially curative therapy, in situ cervical cancer, ductal carcinoma in situ (DCIS), incidentally discovered asymptomatic thyroid cancer, Prostate Specific Antigen (PSA) recurrence of prostate cancer stable on hormonal therapy with no otherwise detectable disease, and a previous diagnosis of malignancy that has shown no evidence of disease progression for 5 years or longer.
• •9. Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis as well as a history of previous or current significant brain hemorrhage. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids to treat edema for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis, which will be excluded regardless of clinical stability.
• •10. Have active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• •11. Have known history of, or any evidence of active, non-infectious pneumonitis.
• •12. Have an active infection requiring systemic therapy.
• •13. Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• •14. Have known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• •15. Are pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
• •16. Have a diagnosis or known history of Human Immunodeficiency Virus (HIV), unless controlled on antiretroviral drugs and have undetectable levels of HIV antibodies.
• •17. Have known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C.
• •18. Have received a live vaccine within 30 days of planned start of study therapy.
• •19. Have a history of myocarditis, regardless of etiology
• •20. Have a troponin T (TnT) or I (TnI)
• •* i) \> 2x institutional upper limit of normal (ULN) : patient is excluded.
• •* ii) between \> 1 to 2 x ULN enrollment will be permitted if a repeat assessment remains \< 2 x ULN and participant undergoes a cardiac evaluation and is cleared by a cardiologist or cardio-oncologist
• •21. Are patients with impaired decision-making capacity
• •22. Are prisoners or participants who are involuntarily incarcerated. (Note: under certain specific circumstances a person who has been imprisoned may be included as a participant. Strict conditions apply and Bristol-Myers Squibb approval is required).
• •23. Are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
• •24. Have psychological, familial, sociological, or geographical conditions that potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the participant before registration in the trial.