What is the mechanism of action of this treatment?

The most common treatments for melanoma, such as Nivolumab and Relatlimab, work by enhancing the body's immune response against cancer cells. Nivolumab is a PD-1 inhibitor that prevents cancer cells from evading immune detection, while Relatlimab is a LAG-3 inhibitor that further boosts immune activity. The study vaccines IO102/IO103 aim to stimulate the immune system to recognize and attack melanoma cells. This combination is significant for melanoma patients as it potentially offers a more robust and effective immune response, improving the chances of controlling and eliminating the cancer.

What side effects are associated with this type of intervention?

The most common treatments for melanoma, particularly those involving immunotherapies like nivolumab (PD-1 inhibitor) and relatlimab (LAG-3 inhibitor), are associated with a range of immune-related side effects. These can include skin reactions, endocrine disorders, gastrointestinal issues such as colitis, and pneumonitis. Severe adverse events may also occur, including hepatitis and hypophysitis. Combination therapies, while potentially more effective, generally exhibit higher toxicity compared to monotherapies.

What prior FDA approvals exist?

Nivolumab, a PD-1 inhibitor, has received FDA approval for the treatment of melanoma both as a monotherapy and in combination with ipilimumab, a CTLA-4 inhibitor. This combination has shown improved outcomes in terms of progression-free survival and overall survival. Relatlimab, a LAG-3 inhibitor, is being studied in combination with nivolumab to further enhance anti-tumor activity by targeting different immune checkpoints. These treatments aim to provide more effective options for patients with advanced melanoma.

What other types of research exist?

Promising alternatives to IO102/IO103 in combination with nivolumab and relatlimab for melanoma patients include: 1) Bempegaldesleukin plus nivolumab, which is being evaluated in the Phase III PIVOT IO 001 trial for untreated, unresectable, or metastatic melanoma. 2) Nivolumab plus ipilimumab, which has shown efficacy in various trials for advanced melanoma. 3) Talimogene laherparepvec (T-VEC) combined with pembrolizumab, which is being studied in advanced melanoma and has shown promising results in the MASTERKEY-265 trial.

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Cancer Vaccine

IO102/IO103 + Nivolumab-Relatlimab for Melanoma

Phase 2

Recruiting

Led By Michael Postow, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Patient must have a histologically confirmed diagnosis of locally advanced unresectable stage III or metastatic stage IV melanoma not amenable to local therapy

Must not have

Other active, concurrent malignancy that requires ongoing systemic treatment or interferes with radiographic assessment of melanoma response as determined by the investigator

History of motor neuropathy considered to be of autoimmune origin to be of autoimmune origin (e.g., Guillain-Barre syndrome, myasthenia gravis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing new vaccines combined with two existing drugs to treat people with melanoma that can't be surgically removed and who haven't received any treatment yet. The vaccines aim to help the body recognize and attack cancer cells, while the drugs enhance the immune system's ability to fight the cancer. One of the drugs has been shown to greatly improve survival in widespread, inoperable malignant melanoma.

Who is the study for?

This trial is for adults with untreated, unresectable stage III or IV melanoma. Participants must have good performance status, adequate organ function, and no prior systemic therapy against their melanoma in the last 6 months. They should not have brain metastases or a history of severe allergies to study drugs. Contraception is required for those who can bear children.

What is being tested?

The study tests if IO102/IO103 vaccines combined with nivolumab and relatlimab are safe and effective for advanced melanoma treatment. It's designed to see how well this combination works compared to standard treatments.

What are the potential side effects?

Potential side effects may include typical reactions from immunotherapy such as fatigue, skin reactions, inflammation in organs like the liver or lungs, flu-like symptoms from the vaccine component, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active and can carry on all pre-disease activities without restriction.

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

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I have a measurable skin cancer lesion outside of my bones and brain.

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I am 18 years old or older.

Exclusion Criteria

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

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I do not have another cancer that needs treatment or affects melanoma tests.

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I have a history of autoimmune motor neuropathy.

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I am not detained for treatment of a mental or physical illness.

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I have active hepatitis B with a high viral load.

Select...

I have been diagnosed with uveal melanoma.

Select...

I have active hepatitis C with a viral load over 100 IU/mL.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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

Overall Response Rate (ORR)

Secondary study objectives

Incidence of adverse events

Progression-free survival (PFS)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: IO102/IO103, Nivolumab, and RelatlimabExperimental Treatment2 Interventions

All patients will be treated with nivolumab-relatlimab FDC on Day 1 of every 28-day cycle for up to two years. Patients will be treated with IO102/IO103 on Days 1 and 15 of the first two 28-day cycles, then on Day 1 of subsequent cycles for up to two total years of treatment.

0 / 10Eligibility 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

The most common treatments for melanoma, such as Nivolumab and Relatlimab, work by enhancing the body's immune response against cancer cells. Nivolumab is a PD-1 inhibitor that prevents cancer cells from evading immune detection, while Relatlimab is a LAG-3 inhibitor that further boosts immune activity. The study vaccines IO102/IO103 aim to stimulate the immune system to recognize and attack melanoma cells. This combination is significant for melanoma patients as it potentially offers a more robust and effective immune response, improving the chances of controlling and eliminating the cancer.