A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301)

Research summary

This is a Phase 3, randomized, controlled, multicenter, open-label study to evaluate the efficacy of IMC-F106C + nivolumab compared with nivolumab regimens in HLA-A*02:01-positive adult participants with previously untreated advanced (unresectable or metastatic) melanoma. Participants will be randomized 1:1:1 to IMC-F106C 40 mcg + nivolumab (Arm A), IMC-F106C 160 mcg + nivolumab (Arm B), or a nivolumab regimen (Arm C). The control Arm C will be country-specific and include: • Nivolumab + relatlimab, an emerging SoC, in countries where this combination has regulatory authorization for all participants, regardless of programmed death-ligand 1 (PD-L1) status and where drug supply for the combination can be sourced. • Nivolumab monotherapy, which is a global SoC, in all other countries. The use of either nivolumab monotherapy or nivolumab + relatlimab in Arm C will be country-specific and specified by the Sponsor. Investigators cannot select the control arm. The target randomization to nivolumab + relatlimab is approximately 20% of the control arm. After the first approximately 90 participants (approximately 30 per arm) have been randomized and followed for an appropriate period of time, an Independent Data Monitoring Committee (IDMC) will compare safety and limited efficacy data from Arms A and B and select the IMC-F106C dose with which to continue randomization for the primary efficacy analysis. The IDMC will not analyze or compare the efficacy data from Arm C. Randomization to all 3 arms will continue while the IDMC reviews the data. Randomization will be stratified by 1) American Joint Committee on Cancer (AJCC; 8th Edition) M stage with lactate dehydrogenase (LDH; M0 or M1 with normal LDH levels vs M1 with elevated LDH levels); 2) prior anti-PD-1/PD-L1 (PD-[L]1) adjuvant therapy (yes vs no); and 3) BRAF V600 mutation status (positive vs negative).

Principal Investigator

Dr Miranda Payne

Contact us

Email: latephaseoncology@ouh.nhs.uk

IRAS number

1008684