680 Participants Needed

IMC-F106C vs Nivolumab for Melanoma

(PRISM-MEL-301 Trial)

Recruiting at 194 trial locations
IT
IM
IM
Overseen ByImmunocore Medical Information EU
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have an active autoimmune disease requiring immunosuppressive treatment, you may not be eligible to participate.

What data supports the effectiveness of the drug IMC-F106C for melanoma?

Tebentafusp, a similar drug to IMC-F106C, has shown a survival benefit in patients with metastatic uveal melanoma, indicating potential effectiveness in targeting melanoma cells. Additionally, nivolumab, another component of the treatment, has been effective in treating skin melanoma, suggesting that combining these therapies could improve outcomes for melanoma patients.12345

What is the safety profile of Nivolumab and related treatments for melanoma?

Nivolumab, also known as Opdivo, is generally considered safe for treating melanoma, but it can cause side effects like fatigue, diarrhea, and skin rash. It may also lead to immune-related reactions, which can be serious. Long-term safety data show that while it has high antitumor activity, it can cause immune-related adverse events that need careful management.678910

How does the drug IMC-F106C differ from other melanoma treatments?

IMC-F106C is a novel treatment that targets PRAME (a cancer-associated protein) and CD3 (a protein on T-cells), potentially offering a unique mechanism compared to existing melanoma treatments like nivolumab and relatlimab, which target PD-1 and LAG-3 proteins to boost the immune response against cancer.211121314

What is the purpose of 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 is for adults with advanced melanoma who haven't been treated before. They must have a specific genetic marker (HLA-A*02:01), be able to use effective birth control, and have a certain level of physical fitness (ECOG score 0 or 1). People can't join if they have serious lung or heart problems, other cancers, untreated brain metastases, allergies to the drugs being tested, active autoimmune diseases needing treatment, prior cancer therapy for their melanoma, or severe reactions to similar drugs.

Inclusion Criteria

I have a confirmed adequate tumor tissue sample.
My melanoma is at Stage IV or is an unresectable Stage III.
You must have a measurable disease according to specific medical guidelines.
See 6 more

Exclusion Criteria

I have untreated brain metastases or carcinomatous meningitis.
I have a serious lung condition or my lungs don’t work well.
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
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive brenetafusp (IMC-F106C) plus nivolumab or standard nivolumab regimens

Up to 51 weeks
Weekly visits for the first 13 weeks, then every 2 weeks through Week 51, and every 4 weeks thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 36 months

Treatment Details

Interventions

  • IMC-F106C
  • Nivolumab
  • Relatlimab
Trial Overview The study compares IMC-F106C combined with nivolumab against standard treatments using nivolumab alone or with relatlimab in patients with advanced melanoma. It's randomized and controlled which means participants are placed into groups by chance and compared against each other.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm B: Brenetafusp High Dose + NivolumabExperimental Treatment2 Interventions
Participants receive brenetafusp High Dose once weekly (QW) for the first 13 weeks, then every 2 weeks (Q2W) through Week 51, and then every 4 weeks (Q4W). Nivolumab is given Q4W.
Group II: Arm A: Brenetafusp Low Dose + NivolumabExperimental Treatment2 Interventions
Participants receive brenetafusp Low Dose once weekly (QW) for the first 13 weeks, then every 2 weeks (Q2W) through Week 51, and then every 4 weeks (Q4W). Nivolumab is given Q4W.
Group III: Arm C: Nivolumab OR Nivolumab + RelatlimabActive Control2 Interventions
Participants receive nivolumab 480 mg monotherapy, or nivolumab 480 mg + relatlimab 160 mg, Q4W.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Immunocore Ltd

Lead Sponsor

Trials
17
Recruited
4,400+

Findings from Research

In a phase 1b trial involving 85 heavily pretreated patients with metastatic cutaneous melanoma, tebentafusp combined with durvalumab and/or tremelimumab showed a promising overall survival rate of 76% at one year, indicating potential efficacy for patients who had previously progressed on checkpoint inhibitors.
The combination therapy was well-tolerated, with no new safety concerns or treatment-related deaths reported, suggesting that tebentafusp can be safely administered alongside existing checkpoint inhibitors.
Tebentafusp in combination with durvalumab and/or tremelimumab in patients with metastatic cutaneous melanoma: a phase 1 study.Hamid, O., Hassel, JC., Shoushtari, AN., et al.[2023]
Nivolumab (Opdivo) monotherapy led to complete regression of local recurrence and multiple lung metastases in a patient with recurrent skin melanoma and a positive BRAF mutation, demonstrating its efficacy as a treatment option.
After 5 courses of nivolumab, the patient experienced significant improvement in her condition, achieving an ECOG performance status of 0, indicating a return to an active lifestyle without pain, and normal serum LDH levels.
[EVALUATION OF THE EFFICASY OF THE DRUG OPDIVO (NIVOLUMAB) IN A PATIENT DIAGNOSED WITH UNRESECTABLE SKIN MELANOMA, POSITIVE BRAF MUTATION AND DISEASE DISSEMINATION (CASE REPORT)].Samsonia, M., Kandelaki, M., Gibradze, O., et al.[2021]
Tebentafusp is a groundbreaking bispecific T cell engager that targets HLA-A*02:01-positive uveal melanoma cells, activating T cells to attack and destroy tumor cells, demonstrating its mechanism of action in cancer treatment.
In January 2022, tebentafusp became the first approved treatment for adults with unresectable or metastatic uveal melanoma in the USA, with ongoing regulatory reviews in other countries, highlighting its significance in melanoma therapy.
Tebentafusp: First Approval.Dhillon, S.[2023]

References

Tebentafusp in combination with durvalumab and/or tremelimumab in patients with metastatic cutaneous melanoma: a phase 1 study. [2023]
2.Georgia (Republic)pubmed.ncbi.nlm.nih.gov
[EVALUATION OF THE EFFICASY OF THE DRUG OPDIVO (NIVOLUMAB) IN A PATIENT DIAGNOSED WITH UNRESECTABLE SKIN MELANOMA, POSITIVE BRAF MUTATION AND DISEASE DISSEMINATION (CASE REPORT)]. [2021]
Tebentafusp: First Approval. [2023]
Tebentafusp: a novel drug for the treatment of metastatic uveal melanoma. [2023]
Gp-100 as a Novel Therapeutic Target in Uveal Melanoma. [2021]
Safety of Nivolumab plus Low-Dose Ipilimumab in Previously Treated Microsatellite Instability-High/Mismatch Repair-Deficient Metastatic Colorectal Cancer. [2020]
FDA Approval of Nivolumab for the First-Line Treatment of Patients with BRAFV600 Wild-Type Unresectable or Metastatic Melanoma. [2018]
An update on the safety of nivolumab for the treatment of advanced melanoma. [2021]
Pharmacovigilance Assessment of Immune-Mediated Reactions Reported for Checkpoint Inhibitor Cancer Immunotherapies. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Autoimmune colitis and neutropenia in adjuvant anti-PD-1 therapy for malignant melanoma: efficacy of Vedolizumab, a case report. [2022]
Nivolumab and relatlimab for the treatment of melanoma. [2023]
Health-related quality of life with nivolumab plus relatlimab versus nivolumab monotherapy in patients with previously untreated unresectable or metastatic melanoma: RELATIVITY-047 trial. [2023]
Indirect treatment comparison of nivolumab versus placebo as adjuvant treatment for resected melanoma. [2021]
14.United Statespubmed.ncbi.nlm.nih.gov
Overall Survival in Patients With Advanced Melanoma Who Received Nivolumab Versus Investigator's Choice Chemotherapy in CheckMate 037: A Randomized, Controlled, Open-Label Phase III Trial. [2022]
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