Melanoma - MSK 23-098

This protocol outlines a single center, phase 2 trial testing the efficacy of combined therapy with IO102/IO103 (programmed death-ligand 1 [PD-L1] and indoleamine 2,3-dioxygenase [IDO] peptide vaccine) and nivolumab-relatlimab fixed-dose combination (FDC) in patients with previously untreated, unresectable Stage III/IV melanoma. Forty-three patients will be enrolled sequentially in a single-arm, nonrandomized two-stage trial design.

Based on reassuring safety profile in the MM1636 trial of IO102-IO103 and nivolumab, the expected toxicity of this investigational combination is low. Rates of adverse events will be continuously evaluated at weekly intervals throughout the study, and a sequential stopping rule will be used if an upper bound of 40% of patients develop treatment-related regimen limiting toxicity (defined in Section 4.0) at any point. Efficacy outcomes will be assessed after enrollment of the first 21 patients prior to enrolling the remainder of the 43-patient cohort. Patients will be treated with nivolumab-relatlimab FDC (Opdualag) every four weeks for up to two years. Patients will be treated with IO102/IO103 on Days 1 and 15 of the first two 28-day cycles, then on Day 1 of subsequent cycles for up to two total years of treatment.

We hypothesize that the combination of IO102/IO103 and nivolumab-relatlimab FDC will be associated with a higher objective response rate (ORR) compared to historical response rates for nivolumab-relatlimab FDC. We anticipate the study will enroll over the course of 18 months and the study will be completed within two years from enrollment of the last patient.

Criteria:

  1. Patient must have a histologically confirmed diagnosis of locally advanced unresectable stage III or metastatic stage IV melanoma not amenable to local therapy
  2. Patient must have not received any prior systemic therapy directed against unresectable stage III or IV melanoma. Prior neoadjuvant and adjuvant ICIs and BRAF/MEK inhibitors are permitted as long as the last dose was > 6 months prior to recurrence.
  3. Patients must have at least one extraskeletal, extracranial measurable melanoma lesion.
  4. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status

Location: Hartford Hospital

Contact: Hayley.Dunnack@hhchealth.org (860) 972-5518

Sponsor: Memorial Sloan Kettering Cancer Center

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