Experimental combo targets Hard-to-Treat cancers

NCT ID NCT06545682

Recruiting now Disease control Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study is testing two drugs together — alpelisib and pembrolizumab — in people with metastatic breast cancer or melanoma that has spread to the brain or other organs. The main goal is to find a safe dose and see what side effects occur. Up to 50 adults whose cancer has progressed after standard treatments will take part.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Alpelisib and pembrolizumab
What this could lead to: If it works, this could point toward a new combination treatment for advanced breast cancer or melanoma that has stopped responding to other therapies.
What could go wrong: This is a very early Phase 1 trial with only 50 people, focused on safety and dosing. It is not yet known if the combination will shrink tumors or improve survival, and side effects could be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia breast cancer breast neoplasm melanoma metastatic malignant neoplasm in the brain metastatic melanoma myelodysplastic syndrome triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ACUTE MYELOGENOUS LEUKEMIA (AML) BRAIN METASTASASES BREAST CANCER MELANOMA (SKIN CANCER) MYELODYSPLASTIC SYNDROME (MDS)

Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

MD Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••

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