Study of the Selective PI3K-Beta Inhibitor GSK2636771 in Combination With Pembrolizumab in Patients With Metastatic Melanoma and PTEN Loss
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|ClinicalTrials.gov Identifier: NCT03131908|
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : January 6, 2020
The goal of this clinical research study is to learn if GSK2636771 given in combination with pembrolizumab can help to control the disease in patients with refractory (has not responded to treatment) metastatic melanoma. The safety of this drug combination will also be studied.
This is an investigational study. Pembrolizumab is FDA approved and commercially available and FDA approved for the treatment of several types of cancer, including melanoma. GSK2636771 is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drugs are designed to work.
Up to 41 participants will be enrolled in this study. All will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma and Other Malignant Neoplasms of Skin Metastatic Melanoma||Drug: GSK2636771 Drug: Pembrolizumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of the Selective PI3K-Beta Inhibitor GSK2636771 in Combination With Pembrolizumab in Patients With Metastatic Melanoma and PTEN Loss|
|Actual Study Start Date :||July 17, 2017|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2021|
Experimental: GSK2636771 + Pembrolizumab
Phase I: Participants receive the lowest dose level of GSK2636771. Each new group receives a higher dose of GSK2636771 than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of GSK2636771 is found. Participants receive the same dose level of Pembrolizumab.
Phase II: Participants receive GSK2636771 at the highest dose that was tolerated in Phase 1. Participants receive the same dose level of Pembrolizumab.
Phase I Starting Dose of GSK2636771: 300 mg by mouth given for 21 days.
Phase II Dose of GSK2636771: Maximum tolerated dose from Phase I.
Phase I and II Dose of Pembrolizumab: 200 mg given by vein every 3 weeks.
- Maximum-Tolerated Dose (MTD) of GSK2636771 in Combination with Pembrolizumab in Participants with Metastatic Melanoma and PTEN Loss [ Time Frame: 3 weeks ]Maximum-tolerated dose defined as the highest dose where ≤ 1 out of 6 participants experiences dose limiting toxicities (DLTs).
- Objective Response Rate (ORR) of GSK2636771 in Combination with Pembrolizumab in Participants with Metastatic Melanoma and PTEN Loss [ Time Frame: 12 weeks ]Objective Response Rate (ORR) determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 in metastatic melanoma.
- Overall survival (OS) [ Time Frame: 2 years ]Overall survival (OS) defined from treatment start date to date of death for any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131908
|Contact: Hussein Tawbi, MD, PHDfirstname.lastname@example.org|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Hussein Tawbi, MD,PHD email@example.com|
|Principal Investigator:||Hussein Tawbi, MD, PHD||M.D. Anderson Cancer Center|