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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)
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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
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Secondary ID [1]
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2023-505306-42-00
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Secondary ID [2]
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IMC-F106C-301
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Universal Trial Number (UTN)
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Trial acronym
PRISM-MEL-301
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Melanoma
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS)
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Assessment method [1]
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PFS as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
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Timepoint [1]
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Up to ~24 months
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is the time from randomization to time of death from any cause.
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Timepoint [1]
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Up to ~24 months
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Secondary outcome [2]
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Overall Response Rate (ORR)
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Assessment method [2]
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ORR as assessed by BICR according to RECIST 1.1.
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Timepoint [2]
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Up to ~24 months
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Secondary outcome [3]
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Number of Participants Experiencing =1 Adverse Event (AE)
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Assessment method [3]
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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.
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Timepoint [3]
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Up to ~36 months
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Secondary outcome [4]
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Number of Participants Experiencing =1 Serious Adverse Event (SAE)
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Assessment method [4]
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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.
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Timepoint [4]
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Up to ~36 months
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Secondary outcome [5]
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Number of Participants Experiencing a Dose Interruption, Reduction, or Discontinuation
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Assessment method [5]
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The number of participants with a dose interruption, reduction, or discontinuation due to AE will be reported.
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Timepoint [5]
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Up to ~24 months
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Secondary outcome [6]
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Maximum Plasma Concentration (Cmax) of IMC-F106C
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Assessment method [6]
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The Cmax of IMC-F106C will be reported.
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Timepoint [6]
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Day 1 of Weeks 1, 2, and 3: Predose and 0.5 and 4 hours postdose
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Secondary outcome [7]
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Incidence of anti-IMC-F106C Antibodies
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Assessment method [7]
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The incidence of anti-IMC-F106C antibodies, including neutralizing antibodies, will be reported.
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Timepoint [7]
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Up to ~24 months
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Secondary outcome [8]
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Association between PFS and Intra-Tumor Immune Cells
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Assessment method [8]
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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.
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Timepoint [8]
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Up to ~24 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/12/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2027
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Actual
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Sample size
Target
680
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Gallipoli Medical Research Foundation (Greenslopes Private Hospital) - Greenslopes
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Recruitment hospital [2]
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University of Sydney - Melanoma Institute Australia (MIA) - The Poche Centre - Wollstonecraft
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Recruitment hospital [3]
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The University of Queensland (UQ) - Princess Alexandra Hospital (PAH) - Woolloongabba
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Recruitment postcode(s) [1]
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4120 - Greenslopes
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Recruitment postcode(s) [2]
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- Wollstonecraft
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Recruitment postcode(s) [3]
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- Woolloongabba
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Colorado
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United States of America
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New York
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United States of America
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State/province [4]
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Pennsylvania
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Country [5]
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United States of America
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State/province [5]
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South Carolina
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Country [6]
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Austria
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State/province [6]
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Pölten
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Country [7]
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France
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State/province [7]
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Boulogne-Billancourt
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Country [8]
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France
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State/province [8]
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Villejuif
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Germany
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State/province [9]
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Heidelberg
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Italy
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Napoli
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Italy
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State/province [11]
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Padova
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Country [12]
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Poland
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State/province [12]
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Gdansk
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Poland
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State/province [13]
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Warszawa
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Spain
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State/province [14]
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Madrid
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Spain
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State/province [15]
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Sevilla
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Country [16]
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Switzerland
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State/province [16]
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Zurich
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Immunocore Ltd
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT06112314
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Immunocore Medical Information
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Address
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Phone
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844-466-8661
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT06112314
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