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Monoclonal Antibodies

IMC-F106C vs Nivolumab for Melanoma (PRISM-MEL-301 Trial)

Phase 3

Recruiting

Research Sponsored by Immunocore Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be HLA-A*02:01-positive

Participants must have histologically confirmed Stage IV or unresectable Stage III melanoma

Must not have

Participants with clinically significant pulmonary disease or impaired lung function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~36 months

Awards & highlights

PRISM-MEL-301 Trial Summary

This trial will compare two treatments for advanced melanoma, one with a new drug plus nivolumab, to nivolumab alone.

Who is the study for?

This trial is for adults with advanced melanoma who haven't been treated before. They must have a specific genetic marker (HLA-A*02:01), be able to use effective birth control, and have a certain level of physical fitness (ECOG score 0 or 1). People can't join if they have serious lung or heart problems, other cancers, untreated brain metastases, allergies to the drugs being tested, active autoimmune diseases needing treatment, prior cancer therapy for their melanoma, or severe reactions to similar drugs.Check my eligibility

What is being tested?

The study compares IMC-F106C combined with nivolumab against standard treatments using nivolumab alone or with relatlimab in patients with advanced melanoma. It's randomized and controlled which means participants are placed into groups by chance and compared against each other.See study design

What are the potential side effects?

Possible side effects include immune-related issues like inflammation in various organs; skin reactions; fatigue; potential complications related to lung function; allergic reactions to the medications used; and possibly others not listed here.

PRISM-MEL-301 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am HLA-A*02:01 positive.

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My melanoma is at Stage IV or is an unresectable Stage III.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious lung condition or my lungs don’t work well.

PRISM-MEL-301 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-Free Survival (PFS)

Secondary outcome measures

Association between PFS and Intra-Tumor Immune Cells

Incidence of anti-IMC-F106C Antibodies

Maximum Plasma Concentration (Cmax) of IMC-F106C

+5 more

PRISM-MEL-301 Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm B: IMC-F106C High Dose + NivolumabExperimental Treatment2 Interventions

Participants receive IMC-F106C High Dose QW for the first 12 weeks, then Q2W through Week 51, and then Q4W until Week 101. Nivolumab is given Q4W until Week 101.

Group II: Arm A: IMC-F106C Low Dose + NivolumabExperimental Treatment2 Interventions

Participants receive IMC-F106C Low Dose once weekly (QW) for the first 12 weeks, then every 2 weeks (Q2W) through Week 51, and then every 4 weeks (Q4W) until Week 101. Nivolumab is given Q4W until Week 101.

Group III: Arm C: Nivolumab OR Nivolumab + RelatlimabActive Control2 Interventions

Participants receive nivolumab 480 mg monotherapy, or nivolumab 480 mg + relatlimab 160 mg, Q4W until Week 101.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4750

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Immunocore LtdLead Sponsor

13 Previous Clinical Trials

3,089 Total Patients Enrolled

9 Trials studying Melanoma

2,078 Patients Enrolled for Melanoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any new registrations being accepted for this scientific experiment?

"The clinicaltrials.gov page for this trial indicates that it is no longer actively searching for participants, with the initial posting having been on December 1st 2023 followed by an update occurring October 31st of the same year. However, there are 726 other studies currently recruiting patients at present."

Answered by AI

Has the administration granted clearance for Arm A: IMC-F106C Low Dose + Nivolumab?

"Our experts have graded Arm A: IMC-F106C Low Dose + Nivolumab's safety a 3 due to the abundance of evidence collected during its Phase 3 clinical trial."

Answered by AI

Are numerous facilities carrying out this investigation in Canada?

"This research project is recruiting patients from the Angeles Clinic and Research Institute in West Los Angeles, The Melanoma Center in Colorado, University of Colorado Hospital (UCH) - Medical Campus in Aurora District of Columbia, UCSF Medical Centre's Helen Diller Family Comprehensive Cancer Centre located in San Francisco Florida as well as 62 other locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06112314.

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