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
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To find a recommended dose of the combination of alpelisib and pembrolizumab that can be given to patients with metastatic breast cancer or melanoma.
CONDITIONS
Official 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 must be 18 years or older.
- Willing and able to provide informed consent.
- Have histologically confirmed locally advanced, unresectable, or metastatic melanoma or triple-negative breast cancer that has progressed despite treatments known to prolong survival or for which no standard treatment is available or refused.
- Melanoma patients without brain metastases must have progressed on an anti-PD-1 or anti-PD-L1 regimen.
- Melanoma patients with active untreated brain metastases must have progressed on an anti-PD-1 or anti-PD-L1 regimen.
- TNBC patients with active untreated brain metastases; prior anti-PD-1/PD-L1 treatment not required.
- Brain MRI within 28 days prior to enrollment confirming eligibility.
- Measurable disease based on RECIST v1.1.
- Adequate organ function as defined by study criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 12 weeks.
- Able to swallow and retain oral medication.
- In dose expansion, willingness to provide tissue biopsies before and during treatment.
- Women of childbearing potential must have a negative pregnancy test before starting treatment.
- Agree to use effective contraception during study and for 4 months after last dose.
- Male patients with partners of childbearing potential must use contraception during study and for 4 months after last dose.
You will not qualify if you...
- History or active autoimmune disease such as inflammatory bowel disease, rheumatoid arthritis, systemic sclerosis, lupus, autoimmune vasculitis, autoimmune neuropathies, or autoimmune thyroiditis unless stable on treatment.
- Active infection or serious medical condition in past 6 months.
- Unresolved toxicity greater than Grade 1 from prior anticancer therapy except alopecia and certain anemia.
- Chemotherapy or radiotherapy within 2 weeks (6 weeks for some agents) before starting study treatment.
- Significant gastrointestinal abnormalities affecting absorption.
- Major surgery within 14 days prior to enrollment.
- Severe or uncontrolled systemic diseases including respiratory, liver, kidney, or heart diseases.
- Diagnosed diabetes mellitus type I or uncontrolled type II.
- History of acute or chronic pancreatitis.
- History of severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis.
- Abnormal ECG with prolonged QTc interval or history of long QT syndrome.
- Cardiovascular risk factors including recent heart attack, advanced heart failure, low heart function, or cardiac metastases.
- Poorly controlled high blood pressure.
- For brain metastases cohorts, no untreated lesions larger than 3.0 cm or lesions requiring immediate local therapy.
- Use of high-dose corticosteroids for brain metastases symptoms.
- Poorly controlled seizures or neurological progression due to brain metastases.
- History or current pneumonitis requiring steroids.
- Conditions or treatments that might interfere with trial participation or results.
- Known psychiatric or substance abuse disorders interfering with cooperation.
- Known hepatitis B or C or HIV infection.
- Receipt of live vaccines within 30 days before starting treatment.
- Current or anticipated use of prohibited medications.
- Allergic reactions to drugs similar to alpelisib or pembrolizumab.
- Pregnant or nursing women.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Ecaterina Dumbrava, MD
CONTACT
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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