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Trial record 1 of 1 for:    NCT06112314
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IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) (PRISM-MEL-301)

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ClinicalTrials.gov Identifier: NCT06112314
Recruitment Status : Recruiting
First Posted : November 1, 2023
Last Update Posted : March 7, 2024
Sponsor:
Information provided by (Responsible Party):
Immunocore Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Melanoma Biological: IMC-F106C Biological: Nivolumab Biological: Nivolumab + Relatlimab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 18, 2023
Estimated Primary Completion Date : December 1, 2026
Estimated Study Completion Date : December 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
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.
 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.

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

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

Biological: Nivolumab + Relatlimab
Concentrate for solution for infusion at a unit dose of 10 mg/mL.
Other Name: OPDUALAG


Outcome Measures
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Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Up to ~24 months ]
    PFS as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1).


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to ~24 months ]
    OS is the time from randomization to time of death from any cause.

  2. Overall Response Rate (ORR) [ Time Frame: Up to ~24 months ]
    ORR as assessed by BICR according to RECIST 1.1.

  3. Number of Participants Experiencing ≥1 Adverse Event (AE) [ Time Frame: Up to ~36 months ]
    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.

  4. Number of Participants Experiencing ≥1 Serious Adverse Event (SAE) [ Time Frame: Up to ~36 months ]
    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.

  5. Number of Participants Experiencing a Dose Interruption, Reduction, or Discontinuation [ Time Frame: Up to ~24 months ]
    The number of participants with a dose interruption, reduction, or discontinuation due to AE will be reported.

  6. Maximum Plasma Concentration (Cmax) of IMC-F106C [ Time Frame: Day 1 of Weeks 1, 2, and 3: Predose and 0.5 and 4 hours postdose ]
    The Cmax of IMC-F106C will be reported.

  7. Incidence of anti-IMC-F106C Antibodies [ Time Frame: Up to ~24 months ]
    The incidence of anti-IMC-F106C antibodies, including neutralizing antibodies, will be reported.

  8. Association between PFS and Intra-Tumor Immune Cells [ Time Frame: Up to ~24 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06112314


Contacts
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Contact: Immunocore Medical Information 844-466-8661 medical.information@immunocore.com
Contact: Immunocore Medical Information EU +00 800-744-51111 medinfo.eu@immunocore.com

Locations
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United States, South Carolina
Prisma Health Cancer Institute Recruiting
Greenville, South Carolina, United States, 29605
Australia
University of Sydney - Melanoma Institute Australia (MIA) - The Poche Centre Recruiting
Wollstonecraft, Australia
The University of Queensland (UQ) - Princess Alexandra Hospital (PAH) Recruiting
Woolloongabba, Australia
Sponsors and Collaborators
Immunocore Ltd
More Information
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Responsible Party: Immunocore Ltd
ClinicalTrials.gov Identifier: NCT06112314    
Other Study ID Numbers: IMC-F106C-301
2023-505306-42-00 ( Other Identifier: EU CT Number )
First Posted: November 1, 2023    Key Record Dates
Last Update Posted: March 7, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Skin Neoplasms
 Neoplasms by Site
Skin Diseases
Nivolumab
Relatlimab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action