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NCT03131908 · ClinicalTrials.gov registry record · Phase 1
Study of the Selective PI3K-Beta Inhibitor GSK2636771 in Combination With Pembrolizumab in Patients With Metastatic Melanoma and PTEN Loss
A Phase 1 study of Metastatic Melanoma and Melanoma and Other Malignant Neoplasms of Skin, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT03131908: Active Phase 1 study of Metastatic Melanoma and Melanoma and Other Malignant Neoplasms of Skin, sponsored by M.D. Anderson Cancer Center.
NCT03131908 is a Phase 1 study of Metastatic Melanoma and Melanoma and Other Malignant Neoplasms of Skin that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 27 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03131908, a Phase 1 study of Metastatic Melanoma and Melanoma and Other Malignant Neoplasms of Skin, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Maximum-tolerated dose defined as the highest dose where ≤ 1 out of 6 participants experiences dose limiting toxicities (DLTs).
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG GSK2636771
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2017-07-17 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What the registry record for NCT03131908 still lists
NCT03131908 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (67% lower).
The record links to 2 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03131908 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03131908 about?
NCT03131908 is a clinical study titled "Study of the Selective PI3K-Beta Inhibitor GSK2636771 in Combination With Pembrolizumab in Patients With Metastatic Melanoma and PTEN Loss". 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 investiga...
What is the current status of trial NCT03131908?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2017-07-17. Estimated completion is 2027-12-31.
What conditions does trial NCT03131908 study?
This clinical trial studies the following conditions: Metastatic Melanoma, Melanoma and Other Malignant Neoplasms of Skin.
What interventions are being tested in trial NCT03131908?
The interventions under investigation include: Pembrolizumab (DRUG), GSK2636771 (DRUG).
Who is sponsoring clinical trial NCT03131908?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03131908 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03131908's enrollment target sits among peer trials
27 61st of 91 higher than 31 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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