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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study 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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
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.
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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
1,936 Previous Clinical Trials
588,855 Total Patients Enrolled
76 Trials studying Melanoma
15,935 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have another cancer that needs treatment or affects melanoma tests.I am fully active and can carry on all pre-disease activities without restriction.You are pregnant or breastfeeding, as confirmed by a recent pregnancy test.My melanoma is at an advanced stage and cannot be removed with surgery.I have brain metastases that were treated and I don't have symptoms.I have a measurable skin cancer lesion outside of my bones and brain.Your blood tests must show: enough red blood cells, white blood cells, and platelets; normal liver function; and good kidney function.I am a man who will use effective birth control during and for 4 months after the study, and won't donate sperm.I have had immunotherapy for advanced melanoma or another cancer, but my last dose was over 6 months ago.I have a history of autoimmune motor neuropathy.I haven't had systemic therapy for advanced melanoma, but treatments for earlier stages are okay if they were over 6 months ago.I am not detained for treatment of a mental or physical illness.You have taken high doses of steroid medication or other immune-suppressing drugs in the last two weeks. You have received a live vaccine in the last month.I am 18 years old or older.I have active hepatitis B with a high viral load.I have been diagnosed with uveal melanoma.I have active hepatitis C with a viral load over 100 IU/mL.
Research Study Groups:
This trial has the following groups:- Group 1: IO102/IO103, Nivolumab, and Relatlimab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this clinical experiment in progress?
"The trial, which was launched on June 9th 2023 and updated last on the 23rd of that same month, is currently open for patient recruitment. This information can be found online by referencing clinicaltrials.gov."
Answered by AI
What potential harms could patients incur through exposure to IO102/IO103, Nivolumab, and Relatlimab?
"The safety of IO102/IO103, Nivolumab, and Relatlimab was estimated to be a 2 on the 1-3 scale due to this being a phase two trial. This means that there is some data indicating its safety but no evidence supporting efficacy yet."
Answered by AI
What is the overall enrollment size for this research initiative?
"Affirmative. According to the clinicaltrials.gov database, this research endeavour was first posted on June 9th 2023 and has since been updated. It is currently seeking 43 individuals spread across 7 different sites for inclusion in the trial."
Answered by AI
How many healthcare facilities have been appointed to execute this experiment?
"This trial is available at 7 different medical sites, such as Memorial Sloan Kettering Monmouth (Limited Protocol Activities) in Middletown, and Memorial Sloan Kettering Bergen (Limited Protocol Activities) in Montvale. Additionally, there are four other locations that qualify for this clinical research study."
Answered by AI
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