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New treatment option for Melanoma (Skin Cancer)
Official title Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA)
ClinicalTrials.gov ID: NCT06545682
What this study is testing
What is Alpelisib + Pembrolizumab?
Alpelisib + Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for melanoma (skin cancer).
Also referred to as BYL 719.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To find a recommended dose of the combination of alpelisib and pembrolizumab that can be given to patients with metastatic breast cancer or melanoma.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must be 18 years or older.
- Patients must be willing and able to provide informed consent.
- In the dose escalation, patients must have histologically documented locally advanced, unresectable, or metastatic melanoma or TNBC that has...
- In the dose expansion, patients must have histologically documented locally advanced, unresectable, or metastatic melanoma or TNBC that has...
- Melanoma patients without brain metastases who have progressed on an anti-PD-1 or anti-PD-L1-based regimen.
You likely can't join if
- Has a history of or active autoimmune disease, as follows: history of inflammatory bowel disease, history of symptomatic disease (e.g., rheumatoid...
- Has active infection or had a serious general medical condition(s) (such as vascular accident) in the past 6 months.
- Any unresolved \> Grade 1 toxicity (per CTCAE v5.0) from previous anticancer therapy or previously administered agent at the time of enrollment...
- Patients who received chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to starting study treatment.
- Presence of any clinically significant gastrointestinal abnormality or other condition(s) (e.g., ulcerative diseases, uncontrolled nausea, vomiting...
- Previous major surgery within 14 days prior to enrollment.
See the full eligibility criteria
Who can join
- Patients must be 18 years or older.
- Patients must be willing and able to provide informed consent.
- 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...
- In the dose expansion, 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...
- Melanoma patients without brain metastases who have progressed on an anti-PD-1 or anti-PD-L1-based regimen.
- Melanoma patients with active and untreated brain metastases who have progressed on an anti-PD-1 or anti-PD-L1-based regimen.
- TNBC patients (defined as ER \<1%, HER2 0, 1+, 2+, and fluorescence in situ hybridization negative) with active untreated brain metastases. Prior treatment with anti-PD-1/anti-PD-L1 is not required.
- All patients must have had a brain magnetic resonance imaging (MRI) scan in the previous 28 days to confirm eligibility for the following cohorts:
- Dose escalation and dose expansion Cohort 1: Confirmed absence of untreated brain metastases in patients with histologically confirmed advanced melanoma. Prior surgery for brain metastases must have been completed at...
- Dose escalation and dose expansion Cohorts 2 and 3: At least one confirmed measurable untreated brain lesion ≥ 0.5 cm and \< 3.0 cm in the longest axis.
- Has measurable disease based on the RECIST v1.1.
- Has adequate organ function as defined in Table 2:
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 4).
- Has a life expectancy of at least 12 weeks.
- Able to swallow and retain orally administered medication.
- In the dose expansion, patients with EC disease must be willing to provide tissue from a newly obtained, safely accessible core or excisional biopsy lesion at pre-treatment and at least one time point while on study...
- Women of childbearing potential (WOCBP) should have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study treatment. If the urine test is positive or cannot be confirmed as negative...
- Alpelisib and pembrolizumab can cause fetal harm when administered to a pregnant woman. Therefore, WOCBP must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time...
- Postmenopausal (no menses in ≥ 12 consecutive months)
- History of hysterectomy or bilateral salpingo-oophorectomy
- Ovarian failure (follicle-stimulating hormone and estradiol in menopausal range and have received whole pelvic radiation therapy)
- History of bilateral tubal ligation or another surgical sterilization procedure
- Approved methods of birth control are as follows: hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device, tubal ligation or hysterectomy...
- Male patients with partner(s) of childbearing potential must agree to use adequate contraception from the time of screening through 4 months after the last dose of study treatment.
What rules you out
- Has a history of or active autoimmune disease, as follows: history of inflammatory bowel disease, history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus...
- Has active infection or had a serious general medical condition(s) (such as vascular accident) in the past 6 months.
- Any unresolved \> Grade 1 toxicity (per CTCAE v5.0) from previous anticancer therapy or previously administered agent at the time of enrollment, except for alopecia and Grade 2 anemia (if hemoglobin is \> 9 g/dL). Note...
- Patients who received chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to starting study treatment.
- Presence of any clinically significant gastrointestinal abnormality or other condition(s) (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) that may...
- Previous major surgery within 14 days prior to enrollment.
- Evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, hepatic, renal, or cardiac disease).
- Established diagnosis of diabetes mellitus type I or uncontrolled type II (based on fasting blood glucose and HbA1c [see inclusion criteria #4]).
- History of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis.
- History of severe cutaneous reaction, such as SJS, erythema multiforme (EM), TEN, or drug reaction with eosinophilia and systemic symptoms (DRESS).
- Based on average of triplicate 12-lead electrocardiogram (ECG), a mean resting QTc interval using Fridericia formula \> 450 msec for males and \> 470 msec for females at screening or a history of congenital long QT...
- History or evidence of cardiovascular risk including any of the following:
- History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, stenting, or bypass grafting within 6 months prior to enrollment.
- Class III or IV heart failure as defined by the New York Heart Association functional classification system.
- Known left ventricular ejection fraction \< 50%.
- Known cardiac metastases.
- Poorly controlled hypertension (defined as systolic blood pressure ≥150 mmHg or diastolic blood pressure \>100 mmHg based on a mean of three measurements taken at approximately 2-minute intervals). Note: Initiation or...
- For dose expansion Cohorts 2 and 3 with active brain metastases:
- Patients must not have any of the following on the screening brain MRI:
- 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...
- 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.
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- 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...
- 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.
- Known history of hepatitis B or C or positive test for human immunodeficiency virus.
- Has received a live vaccine within 30 days of planned start of study treatment. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; COVID-19 vaccines are allowed...
- Current use of or anticipated requirement during the study of any prohibited medication(s) (See Section 5.5.2).
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to alpelisib and pembrolizumab.
- Pregnant or nursing.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.