Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
To find a recommended dose of the combination of alpelisib and pembrolizumab that can be given to patients with metastatic breast cancer or melanoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 standard treatment is available or refused such therapy. Presence of active brain metastases is not required. Patients with active metastases as defined below can be eligible in the dose escalation.
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 standard treatment is available or refused such therapy.
Disqualifiers
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 erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]), motor neuropathy considered of autoimmune origin (e.g., Guillain-Barré syndrome and myasthenia gravis), or history of autoimmune thyroiditis (patients may be eligible if their current thyroid disorder is treated and stable with replacement or other medical therapy).
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: If the patient received major surgery, he/she must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
Patients who received chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to starting study treatment.
Trial design
Design model
Single group
Treatments tested in this trial
Alpelisib + Pembrolizumab
DrugGiven by mouth (PO) Given by vein (IV)
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Dose EscalationExperimental treatment 1 intervention
Group B: Dose ExpansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse Events
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame
Through study completion; an average of 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov