Clinical Trial TitleNivolumab plus ipilimumab plus sargramostin versus nivolumab plus ipilimumab in patients with unresectable stage III or stage IV melanoma.
Clinical Trial Protocol Description:
To provide combination treatment involving nivolumab, ipilimumab, and sargramostin for patients with unresectable stage III or stage IV melanoma and to collect additional data on treatment safety.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have unresectable stage III or stage IV melanoma. Patients must have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive.
- Have measurable disease per RECIST 1.1 criteria. All sites of disease must be evaluated within 4 weeks prior to randomization.
- Have (ECOG) performance status: 0 or 1.
- Have known BRAF murine mutational status of tumor; wild-type (WT) or mutated, prior to randomization.
- Have had prior systemic therapy in the adjuvant setting (e.g. interferon, BRAF, or mitogen-activated protein kinase [MEK] agents); may have had prior anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) in the adjuvant setting, if at least one year from last dose of treatment has passed prior to beginning treatment.
- Are 18 years of age and over.
You will be excluded from the study if any of the following criteria apply to you:
- Have had any prior programmed cell death (PD)-1/PD-ligand (PD-L)1 agent in the adjuvant setting.
- Have had any prior ipilimumab and/or anti-PD-1/PD-L1 agent in the metastatic setting.
- Have any currently active central nervous system (CNS) metastases. Patients who have treated brain metastases (with either surgical resection or stereotactic radiosurgery) that have been stable on head magnetic resonance imaging (MRI) or contrast computed tomography (CT) scan for at least 4 weeks following treatment and within 4 weeks prior to randomization are eligible. Patients must not have taken any steroids =< 14 days prior to randomization for the purpose of managing their brain metastases. Patients with only whole brain irradiation for treatment of CNS metastases will be ineligible.
- Have received any other investigational agents within four weeks prior to randomization.
- Have a history of inflammatory bowel disease or diverticulitis (history of diverticulosis is allowed).
This is a partial list of inclusion and exclusion criteria.