Phase 1b Study of Alpelisib and Pembrolizumab for Treating Advanced or Metastatic Breast Cancer and Melanoma

What this Trial Is About

Researchers are studying the combination of alpelisib and pembrolizumab to find a recommended dose for patients with metastatic breast cancer or melanoma, including those with brain metastases. This Phase Ib trial aims to understand the safety, tolerability, and maximum dose that can be given, while also evaluating tumor response and exploring effects on various biomarkers and immune cells. The study is sponsored by M.D. Anderson Cancer Center. Participants will receive alpelisib by mouth and pembrolizumab by vein as outpatient treatments. The study includes two main parts dose escalation to find the right dose and dose expansion to further assess the treatment. Patients may have brain metastases or not, and specific imaging is required to confirm eligibility. Treatment and assessments occur over approximately one year. Throughout the study, participants will have regular evaluations including brain MRI scans, blood tests, tissue biopsies, and assessments of tumor response using standard criteria. Researchers will monitor adverse events and perform detailed biomarker analyses. Participants must be able to swallow medication and have an expected life expectancy of at least 12 weeks. Safety and treatment effects will be followed closely during and after treatment.

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