Plain-English translation of NCT06545682 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 study is testing whether two cancer medications—alpelisib and pembrolizumab—work better together than either one alone in treating advanced melanoma (skin cancer) or triple-negative breast cancer that has spread to other parts of the body, including sometimes the brain. Researchers want to find the safest and most effective dose of this combination, and to see how well it helps patients.
Many patients with advanced melanoma and triple-negative breast cancer stop responding to current treatments, particularly when cancer spreads to the brain. This trial explores whether combining these two medications in a new way might help patients whose cancer is no longer controlled by standard therapies.
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You would take both medications by mouth as an outpatient—meaning you would come to the clinic for visits but not stay overnight. The study has two phases: first, researchers test different doses to find the safest level, then they expand to treat more patients at that dose. You would have regular clinic visits, blood tests, brain imaging, and possibly biopsies to see how the treatment is working and to monitor for side effects.
AI-generated summary from trial data · Jun 9, 2026 · Not medical advice
United States
Phase
Safety & dosing
Sponsor
M.D. Anderson Cancer Center
Enrollment target
~50 participants
Started
October 2024
Primary completion
August 2027
Age range
18 Years and older
Last updated on clinicaltrials.gov in April 2026.
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Central contact
Ecaterina Dumbrava, MD
M.D. Anderson Cancer Center
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.