A Phase 3 Study Comparing Continuous versus Intermittent Anti-PD-1 Therapy in Patients with Unresectable or Metastatic Melanoma

What this Trial Is About

Researchers are studying patients with metastatic melanoma to compare two ways of giving PD-1 inhibitor therapy, a type of immunotherapy that helps the immune system fight cancer. The study aims to find out if taking PD-1 inhibitors intermittently with breaks works as well as continuous non-stop treatment in extending patients lives. This is a Phase III randomized trial led by the Canadian Cancer Trials Group. Participants receive PD-1 inhibitors that are government approved and publicly funded, with doses recommended by the manufacturer. One group takes the treatment continuously for up to two years, while the other takes it intermittently, with breaks when the melanoma improves. The trial compares these two treatment schedules to see if intermittent therapy can provide similar benefits with potentially fewer clinic visits, side effects, and costs. During the study, participants will be monitored over seven years to assess overall survival as the main outcome. Researchers will also measure progression-free survival, response rates, duration of response, side effects, quality of life, and economic impact using questionnaires and clinical evaluations. Participants must complete quality of life questionnaires in English or French and be available for treatment and follow-up visits throughout the study period.

Duration of Anti-PD-1 Therapy in Metastatic Melanoma