Randomized Phase II/III Study of Nivolumab plus Ipilimumab plus Sargramostim Versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma

Protocol: ECOG – EA6141

SCHEMA EA6141

Please Note: Below is partial 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!

Eligibility:

1. Must be at least 18 years of age.
2. ECOG Performance Status 0-1
3. Patients must have known BRAF mutational status of tumor; Wildtype (WT) or mutated.
4. Patients must have unresectable stage III or stage IV melanoma according to AJCC v7. Patients must have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive.
5. Patients must have measurable disease.
6. Patients may have had prior systemic therapy in the adjuvant setting (e.g. interferon, BRAF, or MEK agents). Patients may have had prior anti-CTLA-4 in the adjuvant setting, if at least one year from last dose
   of treatment has passed prior to beginning treatment. Patients may have had any prior anti-PD-1 or anti-PD-L1 agent in the adjuvant setting, if at least one year from last dose of treatment has passed prior to beginning treatment.
7. Patients may not have had any prior ipilimumab and/or anti-PD-1/PDL1 agent in the metastatic setting.
8. Patients must have discontinued chemotherapy, immunotherapy or other investigational agents used in the adjuvant setting ≥ 4 weeks prior to randomization and recovered from adverse events due to those agents.
9. Patients must not receive any other investigational agents while on study or within four weeks prior to randomization.
10. Patient must not have received any live vaccine within 30 days prior to randomization.
11. Patients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast. Patients with other malignancies are eligible if they have been continuously disease-free for > 3 years prior to the time of randomization.
12. Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids.
13. Patients must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment that in the opinion of the investigator may interfere with compliance, make the administration of the study drugs hazardous or obscure the interpretation of AEs, such as a condition associated with frequent
    diarrhea.