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

Advanced Melanoma Clinical Trial

— PRISM-MEL-301  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06112314
• Other study ID #: IMC-F106C-301
• Secondary ID: 2023-505306-42-0
• Status: Recruiting
• Phase: Phase 3
• Start date: December 18, 2023
• Est. completion date: December 1, 2027

Study information

• Verified date: June 2024
• Source: Immunocore Ltd
• Contact: Immunocore Medical Information
• Phone: 844-466-8661
• Email: medical.information[@]immunocore.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 680
• Est. completion date: December 1, 2027
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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

• Archived or fresh tumor tissue sample that must be confirmed as adequate

• Participants must have measurable disease per RECIST 1.1

• Participant must have BRAF V600 mutation status determined

• Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

• Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the study screening date until 5 months after the final dose of study intervention

Exclusion Criteria:

• Participants with a history of a malignant disease other than those being treated in this study

• Participants with untreated, active, or symptomatic central nervous system (CNS) metastases or carcinomatous meningitis

• Hypersensitivity to IMC-F106C, nivolumab, relatlimab, or any associated excipients

• Participants with clinically significant pulmonary disease or impaired lung function

• Participants with clinically significant cardiac disease or impaired cardiac function

• Participants with active autoimmune disease requiring immunosuppressive treatment

• Participants with any medical condition that is poorly controlled or that would, in the Investigator's or Sponsor's judgment, adversely impact the participant's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results

• Participants who received prior systemic anticancer therapy for unresectable or metastatic melanoma

• Participants with a history of a life-threatening AE related to prior anti-PD-(L)1 or anti-LAG-3

Related Conditions & MeSH terms

• Advanced Melanoma
• Melanoma

Intervention

Biological:
• IMC-F106C
Soluble PRAME-specific T cell receptor with anti-CD3 scFV concentrate for solution for intravenous (IV) infusion at a unit dose of 0.2 mg/mL.
• Nivolumab
Concentrate for solution for infusion at a unit dose of 10 mg/mL.
• Nivolumab + Relatlimab
Concentrate for solution for infusion at a unit dose of 10 mg/mL.

Locations

Country	Name	City	State
Australia	Gallipoli Medical Research Foundation (Greenslopes Private Hospital)	Greenslopes	Queensland
Australia	University of Sydney - Melanoma Institute Australia (MIA) - The Poche Centre	Wollstonecraft
Australia	The University of Queensland (UQ) - Princess Alexandra Hospital (PAH)	Woolloongabba
Austria	Universitätsklinikum St. Pölten	Pölten
France	Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Ambroise-Pare	Boulogne-Billancourt
France	Institut Gustave Roussy (IGR) Service de Dermatolgie	Villejuif
Germany	Universitaetsklinikum Heidelberg (UKHD) - Hautklinik	Heidelberg
Italy	Istituto Nazionale Tumori (INT) "Fondazione G. Pascale" di Napoli	Napoli
Italy	Istituto Oncologico Veneto (IOV) IRCCS	Padova
Poland	Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Klinika Nowotworów Tkanek Miekkich, Kosci i Czerniaków	Warszawa
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Switzerland	UniversitaetsSpital Zuerich - Dermatologische Klinik	Zurich
United States	University of Colorado, Anschutz Medical Campus	Aurora	Colorado
United States	Prisma Health Cancer Institute	Greenville	South Carolina
United States	The Angeles Clinic and Research Institute- West Los Angeles	Los Angeles	California
United States	UCLA Hematology/Oncology	Los Angeles	California
United States	Columbia University Medical Center	New York	New York
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Immunocore Ltd

Countries where clinical trial is conducted

United States,  Australia,  Austria,  France,  Germany,  Italy,  Poland,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	PFS as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1).	Up to ~24 months
Secondary	Overall Survival (OS)	OS is the time from randomization to time of death from any cause.	Up to ~24 months
Secondary	Overall Response Rate (ORR)	ORR as assessed by BICR according to RECIST 1.1.	Up to ~24 months
Secondary	Number of Participants Experiencing =1 Adverse Event (AE)	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.	Up to ~36 months
Secondary	Number of Participants Experiencing =1 Serious Adverse Event (SAE)	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.	Up to ~36 months
Secondary	Number of Participants Experiencing a Dose Interruption, Reduction, or Discontinuation	The number of participants with a dose interruption, reduction, or discontinuation due to AE will be reported.	Up to ~24 months
Secondary	Maximum Plasma Concentration (Cmax) of IMC-F106C	The Cmax of IMC-F106C will be reported.	Day 1 of Weeks 1, 2, and 3: Predose and 0.5 and 4 hours postdose
Secondary	Incidence of anti-IMC-F106C Antibodies	The incidence of anti-IMC-F106C antibodies, including neutralizing antibodies, will be reported.	Up to ~24 months
Secondary	Association between PFS and Intra-Tumor Immune Cells	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.	Up to ~24 months