PRISM-MEL-301: IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)

The Cmax of IMC-F106C will be reported.

OS is the time from randomization to time of death from any cause.

ORR as assessed by BICR according to RECIST 1.1.

An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition that occur in the study.

An SAE is any untoward medical consequence that results in death; requires inpatient hospitalization or prolongs existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or any other important medical event in the opinion of the Investigator.

The number of participants with a dose interruption, reduction, or discontinuation due to AE will be reported.

The incidence of anti-IMC-F106C antibodies, including neutralizing antibodies, will be reported.

The potential association between the effect of IMC-F106C on efficacy and intra-tumor environment will be explored. Intra-tumor environment is estimated as the ratio of CD3+ to CD163+ cells and the correlation with PFS will be estimated by the hazard ratio (+/- 95% CI) from a Cox model. This analysis will be restricted to subjects randomized to receive IMC-F106C.

The change from baseline over time and between treatments of health-related quality of life will be reported.