Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA)
NCT06545682 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-04-16
Summary
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
- Melanoma (Skin Cancer)
- Breast Cancer
- Brain Metastasases
Interventions
- DRUG
-
Alpelisib + Pembrolizumab
Given by mouth (PO) Given by vein (IV)
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Ecaterina Dumbrava, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-15
- Primary Completion
- 2027-08-03
- Completion
- 2029-08-03
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Interferon Alfa-2b in Treating Patients With Melanoma and Early Lymph Node Metastasis
NCT00004196 ·Status: COMPLETED ·Phase: PHASE3
-
Pembrolizumab and Stereotactic Radiosurgery for Melanoma or Non-Small Cell Lung Cancer Brain Metastases
NCT02858869 ·Status: COMPLETED ·Phase: PHASE1
-
Cisplatin, Temozolomide, Abraxane, With Interleukin-2 and Interferon for Metastatic Melanoma
NCT00970996 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy of Selinexor in Combination With Pembrolizumab in Recurrent Advanced Melanoma
NCT04768881 ·Status: TERMINATED ·Phase: PHASE2
-
Aldesleukin With or Without Ziv-Aflibercept in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
NCT01258855 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma
NCT02388906 ·Status: COMPLETED ·Phase: PHASE3
-
Radiotherapy & Combi in Metastatic Melanoma
NCT02392871 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Neoadjuvant PD-1 Blockade in Patients with Stage IIB/C Melanoma
NCT03757689 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition
NCT05061134 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed By Surgery
NCT00738361 ·Status: COMPLETED ·Phase: PHASE2
-
Neoadjuvant Pembrolizumab for Unresectable Stage III and Unresectable Stage IV Melanoma
NCT02306850 ·Status: COMPLETED ·Phase: PHASE2
-
IL-2 "SELECT" Tissue Collection Protocol in Patients With Advanced Melanoma
NCT01288963 ·Status: COMPLETED
-
Radiation and Combination Immunotherapy for Melanoma
NCT03850691 ·Status: COMPLETED ·Phase: PHASE2
-
Systemic Therapy With Interferon, Interleukin-2 and BRAF Inhibitor
NCT01603212 ·Status: COMPLETED ·Phase: PHASE1
-
Stereotactic Radiation Therapy and Ipilimumab in Treating Patients With Metastatic Melanoma
NCT02107755 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase I Trial of Normothermic Isolated Limb Infusion (ILI) With Melphalan Plus Buthionine Sulfoximine (BSO) in Patients With Locally Advanced Malignant Melanoma
NCT00661336 ·Status: WITHDRAWN ·Phase: PHASE1
-
Cisplatin, Interferon Alfa, Surgery, and Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma
NCT00003263 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy Study of BMS-908662 in Combination With Ipilimumab in Subjects With Advanced Melanoma
NCT01245556 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase II Study of Neoadjuvant Pembrolizumab & Lenvatinib for Resectable Stage III Melanoma
NCT04207086 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma
NCT00006237 ·Status: COMPLETED ·Phase: PHASE3
-
Ipilimumab and Dabrafenib in the 1st Line Tx of Unresectable Stage III/IV Melanoma
NCT02200562 ·Status: TERMINATED ·Phase: PHASE1
-
Ipilimumab With or Without High-Dose Recombinant Interferon Alfa-2b in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
NCT01708941 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients
NCT04562129 ·Status: RECRUITING ·Phase: PHASE2
-
An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma
NCT03068455 ·Status: COMPLETED ·Phase: PHASE3
-
Combination Chemotherapy, Interferon Alfa, and Interleukin-2 in Treating Patients With Metastatic Melanoma
NCT00002669 ·Status: COMPLETED ·Phase: PHASE2