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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06112314




Registration number
NCT06112314
Ethics application status
Date submitted
19/10/2023
Date registered
1/11/2023
Date last updated
13/06/2024

Titles & IDs
Public title
IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
Scientific 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
Secondary ID [1] 0 0
2023-505306-42-00
Secondary ID [2] 0 0
IMC-F106C-301
Universal Trial Number (UTN)
Trial acronym
PRISM-MEL-301
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - IMC-F106C
Treatment: Other - Nivolumab
Treatment: Other - Nivolumab + Relatlimab

Experimental: Arm A: IMC-F106C Low Dose + Nivolumab - 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.

Experimental: Arm B: IMC-F106C High Dose + Nivolumab - 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.

Active comparator: Arm C: Nivolumab OR Nivolumab + Relatlimab - Participants receive nivolumab 480 mg monotherapy, or nivolumab 480 mg + relatlimab 160 mg, Q4W until Week 101.


Treatment: Other: 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.

Treatment: Other: Nivolumab
Concentrate for solution for infusion at a unit dose of 10 mg/mL.

Treatment: Other: Nivolumab + Relatlimab
Concentrate for solution for infusion at a unit dose of 10 mg/mL.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Up to ~24 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to ~24 months
Secondary outcome [2] 0 0
Overall Response Rate (ORR)
Timepoint [2] 0 0
Up to ~24 months
Secondary outcome [3] 0 0
Number of Participants Experiencing =1 Adverse Event (AE)
Timepoint [3] 0 0
Up to ~36 months
Secondary outcome [4] 0 0
Number of Participants Experiencing =1 Serious Adverse Event (SAE)
Timepoint [4] 0 0
Up to ~36 months
Secondary outcome [5] 0 0
Number of Participants Experiencing a Dose Interruption, Reduction, or Discontinuation
Timepoint [5] 0 0
Up to ~24 months
Secondary outcome [6] 0 0
Maximum Plasma Concentration (Cmax) of IMC-F106C
Timepoint [6] 0 0
Day 1 of Weeks 1, 2, and 3: Predose and 0.5 and 4 hours postdose
Secondary outcome [7] 0 0
Incidence of anti-IMC-F106C Antibodies
Timepoint [7] 0 0
Up to ~24 months
Secondary outcome [8] 0 0
Association between PFS and Intra-Tumor Immune Cells
Timepoint [8] 0 0
Up to ~24 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
680
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Gallipoli Medical Research Foundation (Greenslopes Private Hospital) - Greenslopes
Recruitment hospital [2] 0 0
University of Sydney - Melanoma Institute Australia (MIA) - The Poche Centre - Wollstonecraft
Recruitment hospital [3] 0 0
The University of Queensland (UQ) - Princess Alexandra Hospital (PAH) - Woolloongabba
Recruitment postcode(s) [1] 0 0
4120 - Greenslopes
Recruitment postcode(s) [2] 0 0
- Wollstonecraft
Recruitment postcode(s) [3] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
South Carolina
Country [6] 0 0
Austria
State/province [6] 0 0
Pölten
Country [7] 0 0
France
State/province [7] 0 0
Boulogne-Billancourt
Country [8] 0 0
France
State/province [8] 0 0
Villejuif
Country [9] 0 0
Germany
State/province [9] 0 0
Heidelberg
Country [10] 0 0
Italy
State/province [10] 0 0
Napoli
Country [11] 0 0
Italy
State/province [11] 0 0
Padova
Country [12] 0 0
Poland
State/province [12] 0 0
Gdansk
Country [13] 0 0
Poland
State/province [13] 0 0
Warszawa
Country [14] 0 0
Spain
State/province [14] 0 0
Madrid
Country [15] 0 0
Spain
State/province [15] 0 0
Sevilla
Country [16] 0 0
Switzerland
State/province [16] 0 0
Zurich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Immunocore Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT06112314
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Immunocore Medical Information
Address 0 0
Country 0 0
Phone 0 0
844-466-8661
Fax 0 0
Email 0 0
medical.information@immunocore.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06112314