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NCT06112314 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Advanced Melanoma, sponsored by Immunocore.

Recruiting
Registry status
Phase 3
Development phase
680
Enrollment target
20
Study locations

NCT06112314 is a Phase 3 study of Advanced Melanoma that is actively recruiting participants, run by Immunocore. The registered enrollment target is 680 participants, above the 139-participant average among 21 other Advanced Melanoma trials with a reported enrollment target (389% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT06112314, a Phase 3 study of Advanced Melanoma, is actively recruiting participants, sponsored by Immunocore.

RECRUITING
Registry status
Phase 3
Development phase
680 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Nivolumab
  • DRUG Nivolumab + Relatlimab
  • DRUG Brenetafusp

Study Locations (20)

California

  • University of California - San Diego - La Jolla
  • The Angeles Clinic and Research Institute- West Los Angeles - Los Angeles
  • ESC Norris Comprehensive Cancer Center - Los Angeles
  • UCLA Hematology/Oncology - Los Angeles
  • Stanford Cancer Institute - Stanford Cancer Center Palo Alto - Palo Alto
  • Saint John's Health Center - John Wayne Cancer Institute (JWCI) - Santa Monica

Colorado

  • University of Colorado, Anschutz Medical Campus - Aurora
  • The Melanoma & Skin Cancer Institute - Denver

Florida

  • Mayo Clinic Florida - Jacksonville
  • University of Miami Health System-Sylvester Comprehensive Cancer Center-Miami - Miami

Massachusetts

  • Massachusetts General Hospital - Boston
  • Dana Farber Cancer Institute - Boston

Arizona

  • University of Arizona - Tucson

Connecticut

  • UConn Health-Farmington (University of Connecticut Health Center (UCHC)) - Farmington

District of Columbia

  • Georgetown University - Washington D.C.

Illinois

  • Northwestern University - Robert H. Lurie Comprehensive Cancer Center - NMDTI - Chicago

Trial Details

FieldValue
Enrollment Target 680 participants
Start Date 2024-06-05
Est. Completion 2027-10-16
Phase Phase 3

Sponsor

Immunocore

8 total trials

What the Registry Record Tells You About NCT06112314

The ClinicalTrials.gov registry entry for NCT06112314 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 680 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 139-participant average among 21 other Advanced Melanoma trials with a reported enrollment target (389% higher). The listed sponsor is Immunocore, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Advanced Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.

NCT06112314 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Colorado, Florida.

Frequently Asked Questions

What is clinical trial NCT06112314 about?

NCT06112314 is a clinical study titled "IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)". 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.

What is the current status of trial NCT06112314?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 680 participants. The study started on 2024-06-05. Estimated completion is 2027-10-16.

What conditions does trial NCT06112314 study?

This clinical trial studies the following conditions: Advanced Melanoma.

What interventions are being tested in trial NCT06112314?

The interventions under investigation include: Nivolumab (DRUG), Nivolumab + Relatlimab (DRUG), Brenetafusp (DRUG).

Who is sponsoring clinical trial NCT06112314?

This trial is sponsored by Immunocore, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06112314 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.