Actively Recruiting
Phase Ib Study of Alpelisib With Pembrolizumab in Patients With Metastatic Breast Cancer or Melanoma (SELENA)
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older
- Willing and able to provide informed consent
- Histologically confirmed locally advanced, unresectable, or metastatic melanoma or triple-negative breast cancer (TNBC) with progression after standard treatments or no available standard treatment
- Melanoma patients without brain metastases must have progressed on anti-PD-1 or anti-PD-L1 therapy
- Melanoma patients with active untreated brain metastases must have progressed on anti-PD-1 or anti-PD-L1 therapy
- TNBC patients with active untreated brain metastases (prior anti-PD-1/PD-L1 treatment not required)
- Brain MRI within 28 days before enrollment to confirm eligibility based on brain metastases status
- Measurable disease per RECIST v1.1
- Adequate organ function
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Able to swallow and retain oral medication
- Willing to provide tissue biopsies if in dose expansion cohort
- Women of childbearing potential must have negative pregnancy test and agree to use contraception
- Male patients with partners of childbearing potential must agree to use contraception
You will not qualify if you...
- History or active autoimmune disease except stable thyroid disease
- Active infection or serious medical condition in past 6 months
- Unresolved toxicity greater than Grade 1 from previous therapy (except alopecia and certain anemia)
- Chemotherapy or radiotherapy within 2 weeks (6 weeks for certain drugs) prior to study
- Significant gastrointestinal conditions affecting drug absorption
- Major surgery within 14 days prior to enrollment
- Severe or uncontrolled respiratory, hepatic, renal, or cardiac disease
- Diagnosed diabetes mellitus type I or uncontrolled type II
- History of acute pancreatitis within 1 year or chronic pancreatitis
- Severe skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis
- Abnormal QTc interval or congenital long QT syndrome
- Recent serious cardiovascular events or heart failure class III/IV
- Poorly controlled hypertension
- Untreated brain lesions larger than 3.0 cm or lesions requiring immediate local therapy
- Use of systemic corticosteroids above specified doses for brain metastases
- History of pneumonitis requiring steroids or current pneumonitis
- Psychiatric or substance abuse disorder interfering with participation
- Known hepatitis B, hepatitis C, or HIV infection
- Live vaccine received within 30 days before study start
- Use of prohibited medications during study
- Allergic reactions to similar compounds
- Pregnant or nursing women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 1 year or until disease progression or unacceptable toxicity
Participants receive the combination of alpelisib by mouth and pembrolizumab by vein on an outpatient basis to evaluate safety, tolerability, and dose levels.
Regular outpatient visits during treatment cycles
Duration - Up to approximately 1 year after treatment ends
Participants are monitored for adverse events and long-term safety after treatment completion.
Periodic visits for safety assessments
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Ecaterina Dumbrava, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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