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NCT03693612 · ClinicalTrials.gov registry record · Phase 1
GSK3359609 Plus Tremelimumab for the Treatment of Advanced Solid Tumors
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT03693612 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 26 participants.
The verdict
NCT03693612, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate if the combination of GSK3359609 and tremelimumab is safe and tolerable (Part 1) and provides significant survival benefit to subjects with relapsed/refractory (R/R) Head and Neck Squamous Cell Carcinomas (HNSCC) to warrant further clinical investigation (Part 2). Part 1 (dose escalation) will enroll subjects with advanced, selected solid tumors. Subjects will receive escalating doses of GSK3359609 and tremelimumab in combination in Part 1. Part 2 is randomized expansion and will enroll subjects with R/R HNSCC who have disease progression after receiving at least 1 platinum-based chemotherapy and at least 1 anti-programmed death receptor protein-1 (PD-1)/anti-programmed death-ligand 1 (PD-L1) therapy, whether in combination or separately. In Part 2, subjects will be randomized in a ratio of 2:1 to receive either GSK3359609 in combination with tremelimumab at the recommended Phase 2 dose or investigators choice of a single-agent standard of care (SOC) therapy including paclitaxel, docetaxel or cetuximab. The total duration of subjects in the study will be approximately 4 years.
Interventions
- DRUG Docetaxel
- DRUG Paclitaxel
- DRUG Cetuximab
- DRUG Tremelimumab
- DRUG feladilimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2018-11-26 |
| Est. Completion | 2021-09-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03693612
The ClinicalTrials.gov registry entry for NCT03693612 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Docetaxel is the first listed.
NCT03693612 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03693612 about?
NCT03693612 is a clinical study titled "GSK3359609 Plus Tremelimumab for the Treatment of Advanced Solid Tumors". The purpose of this study is to evaluate if the combination of GSK3359609 and tremelimumab is safe and tolerable (Part 1) and provides significant survival benefit to subjects with relapsed/refractory (R/R) Head and Neck Squamous Cell Carcinomas (HNSCC) to warrant further clinical investigation (Par...
What is the current status of trial NCT03693612?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2018-11-26. Estimated completion is 2021-09-16.
What interventions are being tested in trial NCT03693612?
The interventions under investigation include: Docetaxel (DRUG), Paclitaxel (DRUG), Cetuximab (DRUG), Tremelimumab (DRUG), feladilimab (DRUG).
Who is sponsoring clinical trial NCT03693612?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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