IO102/IO103 + Nivolumab-Relatlimab for Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be on high-dose steroids or other immunosuppressive drugs within 14 days of starting the trial. It's best to discuss your specific medications with the trial team.
Is the combination of IO102/IO103 and Nivolumab-Relatlimab safe for humans?
What makes the IO102/IO103 + Nivolumab-Relatlimab treatment unique for melanoma?
This treatment combines a novel vaccine (IO102/IO103) targeting IDO and PD-L1, which are proteins that help cancer cells evade the immune system, with the immunotherapy drugs nivolumab and relatlimab. This combination aims to enhance the immune response against melanoma by targeting multiple immune checkpoints, potentially improving outcomes for patients who do not respond to standard anti-PD-1 therapies.12346
What data supports the effectiveness of the treatment IO102/IO103 + Nivolumab-Relatlimab for melanoma?
In a study with 30 patients who had not previously received anti-PD1 therapy, the combination of the IO102/IO103 vaccine and nivolumab showed an objective response rate of 80%, with 43% achieving complete responses. The median progression-free survival was 26 months, indicating promising effectiveness for this treatment in metastatic melanoma.12345
Who Is on the Research Team?
James Smithy, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive IO102/IO103 and nivolumab-relatlimab FDC. IO102/IO103 is administered on Days 1 and 15 of the first two 28-day cycles, then on Day 1 of subsequent cycles. Nivolumab-relatlimab FDC is administered on Day 1 of every 28-day cycle.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including the incidence of adverse events up to 100 days after the last dose.
What Are the Treatments Tested in This Trial?
Interventions
- IO102/IO103
- Nivolumab-Relatlimab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
IO Biotech
Industry Sponsor