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SELENA Study: Alpelisib and Pembrolizumab for Metastatic Breast Cancer or Melanoma

This study, called SELENA, is testing a combination of two drugs, alpelisib (given by mouth) and pembrolizumab (given by vein), for people with metastatic breast cancer or melanoma. Metastatic means the cancer has spread to other parts of the body, including the brain. The main goal is to find a safe and effective dose of these two drugs when given together. Researchers will also look at how well the treatment shrinks tumors. You may be able to join if you are 18 or older and have advanced melanoma or triple-negative breast cancer (TNBC) that has progressed on other treatments or for which no standard treatment is available. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 50 participants. It is designed to find the best dose of the drug combination.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Adverse events will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06545682

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~50 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Alpelisib + Pembrolizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Events
Measured over Through study completion; an average of 1 year.

Conditions

Melanoma (Skin Cancer)
Breast Cancer
Brain Metastasases

Explore related trials

Breast CarcinomaMelanoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Ecaterina Dumbrava, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Ecaterina Dumbrava, MD
[email protected]
(713) 792-3934
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Any untreated brain lesions \> 3.0 cm in size.
Any brain lesion thought to require immediate local therapy, including (but not limited to) a lesion in an anatomic site where increase in size or possible treatment-related edema may pose risk to the patient (e.g., brainstem lesions). Patients who undergo local treatment for such lesions may still be eligible for the study. 2. Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of dexamethasone (or equivalent) \> 4 mg.
Poorly controlled (\> 1/week) generalized or complex partial seizures, or manifestation of neurologic progression due to brain metastases notwithstanding CNS-directed therapy. 15. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. 16. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. 17. Has known psychiatric or substance abuse disorder that in the opinion of the treating physician or principal investigator (PI) would interfere with cooperation with the requirements of the trial. 18. Known history of hepatitis B or C or positive test for human immunodeficiency virus. 19. Has received a live vaccine within 30 days of planned start of study treatment.

What this trial measures

  • Adverse EventsThrough study completion; an average of 1 year.

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0