← Back to Search

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

Summary

This trial is testing a new vaccine combo to treat melanoma, with the goal of making it safe & effective.

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.Check my eligibility
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.See study design
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
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
My melanoma is at an advanced stage and cannot be removed with surgery.
Select...
I have a measurable skin cancer lesion outside of my bones and brain.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have another cancer that needs treatment or affects melanoma tests.
Select...
I have a history of autoimmune motor neuropathy.
Select...
I am not detained for treatment of a mental or physical illness.
Select...
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Incidence of adverse events
Progression-free survival (PFS)

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.

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.

Find a Location

Who is running the clinical trial?

IO BiotechIndustry Sponsor
8 Previous Clinical Trials
736 Total Patients Enrolled
2 Trials studying Melanoma
467 Patients Enrolled for Melanoma
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,944 Previous Clinical Trials
589,708 Total Patients Enrolled
76 Trials studying Melanoma
15,975 Patients Enrolled for Melanoma
Michael Postow, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
150 Total Patients Enrolled
5 Trials studying Melanoma
150 Patients Enrolled for Melanoma

Media Library

IO102/IO103 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05912244 — Phase 2
Melanoma Research Study Groups: IO102/IO103, Nivolumab, and Relatlimab
Melanoma Clinical Trial 2023: IO102/IO103 Highlights & Side Effects. Trial Name: NCT05912244 — Phase 2
IO102/IO103 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05912244 — Phase 2
~29 spots leftby Jun 2027