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A Phase III 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)

UCI Specialty Area: Cancer
Principal Investigator: Poorva Vaidya
A Study On:
Melanoma skin

Study Description

This is a phase 3, randomized, controlled study of brenetafusp (IMC-F106C) plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma.

Eligibility

  1. Subjects must be HLA-A*02:01-positive
  2. Subjects must have histologically confirmed Stage IV or unresectable Stage III melanoma
  3. Archived or fresh tumor tissue sample must be confirmed as adequate
  4. Subjects must present measurable disease per RECIST 1.1 guidelines
  5. Subjects must have BRAF V600 mutation status confirmed
  6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Key

  1. History of a malignant disease other than those being treating in this study
  2. Untreated, active, or symptomatic central nervous system metastases OR carcinomatous meningitis
  3. Hypersensitivity to brenetafusp, nivolumab, relatimab, or any associated mediums of administration.
  4. Clinically significant pulmonary disease or impaired lung function
  5. Clinically significant cardiac disease or impaired cardiac function
  6. Prior receipt of systemic anticancer therapy for unresectable or metastatic melanoma
  7. Subjects with a history of life-threatening adverse event (AE) related to prior anti-PD-(L)1 or anti-LAG-3 treatment
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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Eric Vilain, MD, PhD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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