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NCT06129864 · ClinicalTrials.gov registry record · Phase 3
A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy
A Phase 3 study of Locally Advanced Head and Neck Squamous Cell Carcinoma, sponsored by AstraZeneca.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,145
- Enrollment target
- 20
- Study locations
NCT06129864: Recruiting Phase 3 study of Locally Advanced Head and Neck Squamous Cell Carcinoma, sponsored by AstraZeneca.
NCT06129864 is a Phase 3 study of Locally Advanced Head and Neck Squamous Cell Carcinoma that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 1,145 participants, above the 119-participant average among 5 other Locally Advanced Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (862% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06129864, a Phase 3 study of Locally Advanced Head and Neck Squamous Cell Carcinoma, is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,145 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT).
Primary Outcome
PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause (in the absence of progression). The analysis will include all randomized participants with PD-L1 expressing tumors.
Conditions Studied
Interventions
- DRUG volrustomig
Study Locations (20)
California
- Research Site - Fountain Valley
- Research Site - Los Angeles
- Research Site - Orange
- Research Site - San Francisco
- Research Site - Santa Rosa
- Research Site - Whittier
Florida
- Research Site - Fort Myers
- Research Site - Gainesville
- Research Site - Miami
- Research Site - Palm Bay
- Research Site - West Palm Beach
Colorado
- Research Site - Aurora
- Research Site - Colorado Springs
- Research Site - Lone Tree
Arizona
- Research Site - Phoenix
- Research Site - Prescott Valley
Alabama
- Research Site - Birmingham
Arkansas
- Research Site - Springdale
District of Columbia
- Research Site - Washington D.C.
Illinois
- Research Site - Niles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,145 participants |
| Start Date | 2023-12-14 |
| Est. Completion | 2030-09-12 |
| Phase | Phase 3 |
What NCT06129864 shows while recruiting
NCT06129864 is an interventional study that assigns participants to a tested intervention. Its 1,145 participants enrollment target places it among the larger protocols in the corpus, above the 119-participant average among 5 other Locally Advanced Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (862% higher).
The record links to 1 condition, with Locally Advanced Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which volrustomig is the first listed.
NCT06129864 names 20 study sites across 8 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT06129864 about?
NCT06129864 is a clinical study titled "A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy". The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT).
What is the current status of trial NCT06129864?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,145 participants. The study started on 2023-12-14. Estimated completion is 2030-09-12.
What conditions does trial NCT06129864 study?
This clinical trial studies the following conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma.
What interventions are being tested in trial NCT06129864?
The interventions under investigation include: volrustomig (DRUG).
Who is sponsoring clinical trial NCT06129864?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06129864 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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