Study on IO102-IO103 and Pembrolizumab Combination vs. Pembrolizumab Alone for Advanced Melanoma
Sponsor: IO Biotech
ClinicalTrials ID:NCT05155254
This clinical trial is comparing the effectiveness of a new treatment combination, IO102-IO103 with pembrolizumab, against pembrolizumab alone in patients with advanced melanoma that cannot be surgically removed or has spread to other parts of the body.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is testing a new treatment approach for advanced melanoma, a type of skin cancer that cannot be removed by surgery or has spread. The trial is comparing two groups: one receiving a combination of IO102-IO103 and pembrolizumab, and the other receiving only pembrolizumab. The main goal is to see if the combination treatment helps patients live longer without the cancer getting worse. Participants will receive pembrolizumab every three weeks for up to two years. Those in the combination group will also receive IO102-IO103 during this time.
Eligibility Criteria
Inclusion Criteria
- Have advanced melanoma (stage III or IV) that cannot be surgically removed.
- Have not received any previous treatment for advanced melanoma.
- If you have a specific genetic mutation (BRAFV600), you can join if you haven't had rapid disease progression.
- If you had previous treatments that ended at least 6 months ago and did not relapse during or shortly after treatment, you may be eligible.
- Have at least one tumor that can be measured by scans.
- Provide a recent or new biopsy sample for testing.
Exclusion Criteria
- Have cancer that has spread to the brain unless it is stable and not causing symptoms.
- Have had radiation therapy within two weeks before starting the trial treatment.
- Have rapidly progressing melanoma with a BRAFV600 mutation and have already received standard first-line therapy for it.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mid Florida Hematology and Oncology Center | 32763 | Orange City | Florida |
| Orlando Health Cancer Institute | 32806 | Orlando | Florida |
| Roswell Park Cancer Institute | 14221 | Buffalo | New York |
| VCU Massey Cancer Center | 23219 | Richmond | Virginia |
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