NCT06545682

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 measured by multicolor flow cytometry and multimodal single cell analysis, and effects on the leukemic cells as assessed by gene panel analysis and/or single cell DNA-analysis. To evaluate exposure by measuring PK. To evaluate immunogenicity by assessing antidrug antibodies (ADA).

Conditions

• Melanoma (Skin Cancer)
• Breast Cancer
• Brain Metastasases

Interventions

Type	Name	Description
DRUG	Alpelisib + Pembrolizumab	Given by mouth (PO) Given by vein (IV)

Timeline

• Start date: 2024-10-15
• Primary completion: 2027-08-03
• Completion: 2029-08-03
• First posted: 2024-08-09
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study