RecruitingPhase 1NCT06545682

Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA)


Sponsor

M.D. Anderson Cancer Center

Enrollment

50 participants

Start Date

Oct 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To find a recommended dose of the combination of alpelisib and pembrolizumab that can be given to patients with metastatic breast cancer or melanoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called SELENA) is testing a combination of two drugs — alpelisib (a targeted PI3K inhibitor) and pembrolizumab (an immunotherapy) — in people with metastatic melanoma or triple-negative breast cancer (TNBC) that has progressed on prior treatments. **You may be eligible if...** - You are 18 or older with confirmed metastatic melanoma or triple-negative breast cancer - Your cancer has progressed on standard treatments or no standard options are available - You are willing to provide a tumor biopsy sample - You meet required blood count and organ function thresholds **You may NOT be eligible if...** - You have uncontrolled diabetes (alpelisib can raise blood sugar) - You have active autoimmune disease requiring treatment - You have severe lung or heart conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAlpelisib + Pembrolizumab

Given by mouth (PO) Given by vein (IV)


Locations(1)

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06545682


Related Trials