IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
- Conditions
- Advanced (unresectable or metastatic) melanomaMedDRA version: 20.0Level: SOCClassification code: 10040785Term: Skin and subcutaneous tissue disorders Class: 16MedDRA version: 21.1Level: PTClassification code: 10025650Term: Malignant melanoma Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-505306-42-01
- Lead Sponsor
- Immunocore Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 812
Participants must be = 18 years of age, Participant must have a life expectancy of at least 3 months., 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, Participants must be capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the ICF and in this protocol, Participants must agree to provide all necessary samples for biomarker analysis., 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
Participants with a history of a malignant disease other than those being treated in this study, 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 for whom, in the Investigator's judgement, the benefit/risk favors combination therapy with nivolumab/ipilimumab, Participants with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study., Participants who received prior systemic anticancer therapy for unresectable or metastatic melanoma, Participants with activating BRAF mutations with rapidly progressing tumours which pose an immediate threat to an important organ or its function, Participants who received prior treatment with any TCE bispecific therapy, including an ImmTAC molecule, or any cellular therapies (eg, adoptive cell therapy including TCR T-cell therapies)., Participants with a history of a life-threatening AE related to prior anti-PD-(L)1 or anti-LAG-3, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare progression-free survival (PFS) for IMC-F106C + nivolumab to nivolumab regimens;Secondary Objective: To compare overall survival for IMC-F106C + nivolumab to nivolumab regimens, To compare overall response rate for IMC-F106C + nivolumab to nivolumab regimens, To assess the safety of IMC-F106C + nivolumab and nivolumab regimens, To characterize the PK of IMC-F106C, To characterize the ADA to IMC-F106C, To characterize associations between the tumor microenvironment and IMC-F106C efficacy, To evaluate impact of treatments and disease on HRQoL using the EORTC-QLQ-C30 based on change from baseline;Primary end point(s): PFS as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Overall survival;Secondary end point(s):Objective response rate (ORR) as assessed by BICR according to RECIST 1.1;Secondary end point(s):Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and changes from baseline in laboratory parameters, vital signs, and electrocardiograms (ECGs);Secondary end point(s):Dose interruptions and reductions, and dose discontinuation;Secondary end point(s):IMC-F106C PK parameters;Secondary end point(s):Incidence of anti-IMC-F106C antibodies, including neutralizing antibodies;Secondary end point(s):Cluster of differentiation, CD3 and CD163 positive immune cells within the tumor;Secondary end point(s):Change from baseline over time and between treatments for Global Health Status, Social Functioning, Cognitive Functioning, Emotional Functioning, Role Functioning and Physical Functioning