Plain-English translation of NCT03311308 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.
This trial is testing whether combining with pembrolizumab (Keytruda) — an immune therapy drug — can help treat advanced melanoma better than using pembrolizumab alone. You would be randomly assigned to receive either pembrolizumab by itself, or pembrolizumab plus taken twice daily by mouth. The study aims to understand how these treatments work together in the body and whether the combination is more effective and safe.
Advanced melanoma is a serious cancer that needs better treatment options. This medication works by helping your immune system fight cancer cells, but researchers want to know if adding — a common diabetes medication — might make the treatment work even better by improving how cancer cells respond to the immune therapy.
You would visit the clinic regularly to receive your assigned medication — either pembrolizumab as an IV infusion every three weeks, or the same infusion plus pills twice daily for nine weeks. Treatment can continue for up to two years if your cancer responds well and you tolerate it without serious side effects. You would also have blood tests and scans to monitor your response, and a tumor biopsy at the start. After leaving the study, researchers will follow up with you for five years through clinic visits, phone calls, or medical records to track your long-term health.
AI-generated summary from trial data · Jun 7, 2026 · Not medical advice
United States
Phase
Safety & dosing
Sponsor
Yana Najjar
Collaborators
Merck Sharp & Dohme LLC
Enrollment target
~23 participants
Started
February 2018
Primary completion
January 2028
Age range
18 Years and older
Last updated on clinicaltrials.gov in June 2026.