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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06545682
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alpelisib + Pembrolizumab — DRUG
    Given by mouth (PO) Given by vein (IV)

Study Details

To find a recommended dose of the combination of alpelisib and pembrolizumab that can be given to patients with metastatic breast cancer or melanoma.

Key Dates

Start date
Oct 15, 2024
Status verified
Apr 2026
Primary completion
Aug 3, 2027
Completion
Aug 3, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Study treatment will be administered on an outpatient basis.
  • Experimental: Dose Expansion
    Study treatment will be administered on an outpatient basis.

Primary Outcome Measure

Adverse Events [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Ecaterina Dumbrava, MD
[email protected]
713-792-3934

Find similar trials in Houston, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
MD Anderson Cancer Center· Houston, TX

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