What side effects are associated with this type of intervention?

Common treatments for melanoma, such as dual-antigen immunotherapy combined with PD-1 inhibitors like pembrolizumab, often lead to immune-related adverse events. These can include skin reactions (e.g., rash, pruritus), endocrine disorders (e.g., hypothyroidism, adrenal insufficiency), and gastrointestinal issues (e.g., colitis, diarrhea). More severe side effects may involve pneumonitis, hepatitis, and nephritis. While these treatments can be effective, they are associated with higher toxicity, necessitating careful management of adverse events.

What prior FDA approvals exist?

The FDA has approved several immunotherapies for the treatment of melanoma, particularly those targeting the PD-1 pathway. Pembrolizumab, a PD-1 inhibitor, has been approved for advanced melanoma based on its ability to enhance the immune response against tumor cells. Additionally, combination therapies such as nivolumab (another PD-1 inhibitor) with ipilimumab (a CTLA-4 inhibitor) have shown efficacy in improving overall survival in melanoma patients. These treatments aim to boost the body's immune system to better recognize and attack melanoma cells, similar to the dual-antigen immunotherapy being studied in combination with pembrolizumab in the IO102-IO103 trial.

What other types of research exist?

Promising alternatives to IO102-IO103 in combination with pembrolizumab for melanoma patients include: 1) Nivolumab (PD-1 inhibitor) plus Ipilimumab (CTLA-4 inhibitor), which has demonstrated long-term overall survival benefits in advanced melanoma. 2) Pembrolizumab combined with a VEGF inhibitor like axitinib, which has shown increased activity in certain sarcomas and may be applicable to melanoma. 3) Nivolumab combined with relatlimab (LAG-3 inhibitor), which is another novel combination showing efficacy in melanoma treatment.

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Monoclonal Antibodies

IO102-IO103 + Pembrolizumab for Advanced Melanoma

Phase 3

Waitlist Available

Led By Inge Marie Svane, MD, Prof

Research Sponsored by IO Biotech

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer 8th edition guidelines not amenable to local therapy

At least 1 measurable lesion according to response evaluation criteria for solid tumors (RECIST v1.1) and confirmed by IRC

Must not have

Patients with BRAFV600-positive disease who are experiencing rapidly progressing disease and/or have received standard first-line therapy with BRAF and/or MEK inhibitor for unresectable or metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5.5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial tests a new treatment (IO102-IO103) combined with an existing drug (pembrolizumab) for patients with advanced melanoma that hasn't been treated and can't be surgically removed. The treatment works by boosting the immune system to attack cancer cells more effectively. Pembrolizumab is a standard treatment for advanced melanoma and has been shown to improve survival rates.

Who is the study for?

This trial is for adults with advanced melanoma that hasn't been treated before. It's open to those with a specific BRAFV600 mutation, provided they haven't had rapid disease progression or prior systemic cancer treatment for their condition. They must have at least one measurable tumor and can't have central nervous system metastases as the only active disease site.

What is being tested?

The study compares IO102-IO103 combined with pembrolizumab against pembrolizumab alone in first-line treatment of unresectable or metastatic melanoma. Patients will receive treatments every three weeks, up to two years, aiming to see if the combination improves survival without disease progression.

What are the potential side effects?

Potential side effects include immune-related reactions such as inflammation in various organs, infusion-related symptoms like fever or chills, fatigue, skin issues, and possibly an increased risk of infections due to immune system changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My melanoma is at an advanced stage and cannot be removed with surgery.

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I have at least one tumor that can be measured.

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I have not received any treatment for my advanced melanoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has a BRAFV600 mutation and is worsening quickly after standard treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 5.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 5.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

Complete response rate (CRR)

Disease control rate (DCR)

Durable Objective response rate (DRR)

+6 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: IO102-IO103 + pembrolizumabExperimental Treatment2 Interventions

IO102-IO103 subcutaneous injections (85µg) every 3 weeks for a maximum 35 cycles (up to 2 years treatment). Additional dose given during the induction period on Day 8 of cycles 1 and 2. Each patient can be treated for a maximum of 37 administrations in total (up to 2 years treatment). Pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles.

Group II: pembrolizumabActive Control1 Intervention

Pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for melanoma, such as IO102-IO103 and pembrolizumab, work by enhancing the body's immune response against cancer cells. IO102-IO103 is a dual-antigen immunotherapy that targets specific melanoma antigens, boosting the immune system's ability to recognize and destroy melanoma cells. Pembrolizumab, a PD-1 inhibitor, blocks the PD-1 pathway, preventing cancer cells from evading immune detection and allowing the immune system to attack the tumor more effectively. These mechanisms are vital for melanoma patients as they harness the body's natural defenses to combat cancer, potentially improving treatment outcomes and survival rates.

Rhabdomyolysis during high dose interleukin-2 treatment of metastatic melanoma after sequential immunotherapies: a case report.