This is an early-phase clinical trial testing a new drug called BI-1607 for people with melanoma that has spread or cannot be removed by surgery. The aim is to see whether combining BI-1607 with two existing treatments, ipilimumab and pembrolizumab, is safe and more effective than current options. BI-1607 is designed to help the body’s immune system work better by enhancing the effects of ipilimumab and pembrolizumab, two immunotherapies already used to treat melanoma.
Around 35 people are expected to take part in the study, all of whom have melanoma that hasn’t responded to standard treatments.The trial has two parts:
Phase 1: At least 15 participants will be given BI-1607 alongside ipilimumab every three weeks over a 12-week period. Pembrolizumab will be added during the later part of this phase. After the initial 12 weeks, participants who continue in the trial will receive pembrolizumab alone for up to two years. Different groups will receive different dose levels to help researchers find the safest and most effective combination.
Phase 2: Around 20 more participants will receive the dose combination found to be safest in Phase 1. They will follow a similar treatment schedule, beginning with BI-1607, ipilimumab, and pembrolizumab for 12 weeks, followed by pembrolizumab alone.
All treatments are given through a drip into a vein (IV infusion). Participants will be closely monitored throughout the trial, with regular blood tests, scans, and health checks. The lowest dose of BI-1607 will be 350 mg, and the highest will be 700 mg. Ipilimumab will be given at 1 or 3 mg per kilogram of body weight, and pembrolizumab at 200 mg.
The trial will also look at how the treatment affects the immune system and how well it controls the cancer. Researchers will monitor any side effects, including serious ones that could stop treatment.
While participants may not benefit personally, their involvement could help improve treatment for future melanoma patients.
The study began in late 2024 and is expected to run until 2028.