Health TrialsbyHealthPanel

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

ConditionAdvanced Melanoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmunocore Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Brenetafusp

    Drug

    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

    Drug

    Concentrate for solution for infusion at a unit dose of 10 mg/mL.

  • Nivolumab + Relatlimab

    Drug

    Concentrate for solution for infusion at a unit dose of 16 mg/mL.

Treatment groups

680 Participants
are divided into 3 treatment groups
Group A: Arm A: Brenetafusp Low Dose + NivolumabExperimental treatment 2 interventions
Group B: Arm B: Brenetafusp High Dose + NivolumabExperimental treatment 2 interventions
Group C: Arm C: Nivolumab OR Nivolumab + RelatlimabActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

PFS as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1).

Time frame
Up to ~45 months

Secondary outcomes

1

Overall Survival (OS)

OS is the time from randomization to time of death from any cause.

Time frame
Up to ~57 months
2

Overall Response Rate (ORR)

ORR as assessed by BICR according to RECIST 1.1.

Time frame
Up to ~45 months
3

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.

Time frame
Up to ~57 months
4

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.

Time frame
Up to ~57 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Immunocore Ltd

Lead sponsor

Source ClinicalTrials.gov
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