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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06545682
Related Trials
Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients
NCT040386191 location
Pulsed Electric Field Ablation for Metastatic Breast Cancer
NCT07487844
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
NCT07619534
A Phase 1 Study of IM-1617 in Participants With Advanced Cancer
NCT075785712 locations
Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies
NCT073405414 locations