IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma
Research type
Research Study
Full title
An open-label, randomized, Phase 3 clinical trial of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable, or metastatic (advanced) melanoma
IRAS ID
1005194
Contact name
Eva Ehrnrooth
Contact email
Sponsor organisation
IO Biotech ApS
Eudract number
2021-004594-32
Clinicaltrials.gov Identifier
Research summary
IO Biotech ApS has begun a study of an investigational drug (also known as the “study drug”) called IO102-IO103 as a possible treatment for melanoma. An investigational drug is one that has not been approved by regulatory agencies, such as the United States (US) Food and Drug Administration (FDA), European Medicines Agency (EMA), or others.
IO102-IO103 is a new drug designed to activate cells in the patient’s immune system (called T cells) to destroy cells that prevent your immune system from killing the cancer cells. IO102-IO103 is also designed to prevent cancer from evading the immune system. By making cancer more visible to the immune system it is thought that the study drug will improve the activity of existing anti-cancer treatments. E.g. the so called checkpoint inhibitor antibodies ‘Pembrolizumab’.
The main goal of this study is to learn how well the study drug (IO102-IO103) works when combined with pembrolizumab and how safe the study drug combined with pembrolizumab is compared with pembrolizumab alone.
The study is planned to take approximately 5.5 years. Participants will receive pembrolizumab or IO102-IO103 and pembrolizumab every 3 weeks for up to around 2 years (35 cycles), after which they will continue to be carefully monitored every 6 months until the end of the study. During the period where participants receive treatment they will visit the study centre every 3 weeks. If their disease worsens (their doctor may call this disease progression) and the study doctor feels they are still benefiting from the study drug(s), the study doctor and Sponsor may decide they can continue taking the study drug(s).
The study consists of 3 types of visits: screening visit, treatment visits, and follow-up visits. The screening visit will last 3 to 4 hours, and visits where participants receive study drug will last 3 to 5 hours. Follow-up visits will last 1.5 to 2 hours.
REC name
London - City & East Research Ethics Committee
REC reference
22/LO/0331
Date of REC Opinion
13 Jun 2022
REC opinion
Further Information Favourable Opinion