At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed melanoma that is unresectable or metastatic (stage III or IV)
- ✓Eligible to receive government-approved and publicly-funded PD-1 inhibitor per Product Monograph/Provincial Formulary
- ✓Evidence of unresectable/metastatic disease evaluable by investigator; measurable disease not mandatory
- ✓Age 18 or older (or as specified in Product Monograph)
- ✕Not willing to stop anti-PD-1 therapy if randomized to intermittent arm
- ✕Any contraindications to PD-1 inhibitors per Product Monograph/Provincial Formulary or not eligible for anti-PD-1 therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase III Trial of the Duration of Anti-PD-1 Therapy in Metastatic Melanoma
In Brief
A Phase 3 clinical trial evaluating Intermittent PD-1 inhibitor therapy and Continuous PD-1 inhibitor therapy for Unresectable/Metastatic Melanoma. Currently recruiting, targeting 614 participants across 30 sites in 2 countries.
Detailed Summary
The purpose of this study is to compare the effects on patients with metastatic melanoma of taking a government approved and paid-for PD-1 inhibitor intermittently, with taking the same type of agent continuously. Researchers want to see if the two ways of giving this type of treatment work equally well in extending the life of patients with melanoma, or not.
Study Details
Timeline
Arms & Interventions
Any PD-1 inhibitor that is commercially available, government approved and publicly funded. Dose as recommended by the manufacturer.
Any PD-1 inhibitor that is commercially available, government approved and publicly funded. Dose as recommended by the manufacturer.