Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA)
M.D. Anderson Cancer Center
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.
Description
Primary Objective: To determine the safety, tolerability, maximum tolerated dose (MTD), and/or recommended Phase II dose (RP2D) of the combination of alpelisib and pembrolizumab in patients with advanced/metastatic melanoma with and without brain metastasis and advanced/metastatic TNBC with brain metastasis. Secondary Objectives: To determine ORR as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in all patients. Exploratory Objectives: To assess effects on exploratory biomarkers, including serum biomarkers, alterations in hematopoietic subpopulations as measure…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients must be 18 years or older. 2. Patients must be willing and able to provide informed consent. 3. In the dose escalation, patients must have histologically documented locally advanced, unresectable, or metastatic melanoma or TNBC that has progressed on treatments that are known to prolong survival or for which no standard treatment is available or refused such therapy. Presence of active brain metastases is not required. Patients with active metastases as defined below can be eligible in the dose escalation. 4. In the dose expansion, patients must have histologic…
Interventions
- DrugAlpelisib + Pembrolizumab
Given by mouth (PO) Given by vein (IV)
Location
- MD Anderson Cancer CenterHouston, Texas