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NCT06727565 · ClinicalTrials.gov registry record · Phase 2
Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Substudy-01
A Phase 2 study of Head and Neck Squamous Cell Carcinoma, sponsored by Gilead Sciences.
- Active
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT06727565: Active Phase 2 study of Head and Neck Squamous Cell Carcinoma, sponsored by Gilead Sciences.
NCT06727565 is a Phase 2 study of Head and Neck Squamous Cell Carcinoma that is active but no longer recruiting, run by Gilead Sciences. The registered enrollment target is 100 participants, below the 116-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (14% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06727565, a Phase 2 study of Head and Neck Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by Gilead Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
Study Summary
Master protocol: The main goal of this master clinical study is to evaluate the efficacy and safety of multiple novel combination therapies in participants with head and neck squamous cell carcinoma (HNSCC) in various substudies. Substudy-01 will evaluate the efficacy and safety of novel combination of treatment regimens, domvanalimab (DOM) and zimberelimab (ZIM) combined with chemotherapy vs ZIM combined with chemotherapy. The primary objective is to assess the efficacy of DOM and ZIM in combination with chemotherapy versus ZIM in combination with chemotherapy.
Primary Outcome
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 using investigator assessments.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- DRUG Zimberelimab
- DRUG Domvanalimab
Study Locations (20)
Other
- Sichuan Cancer Hospital - Chengdu
- Zhejiang Cancer Hospital - Hangzhou
- Guangxi Medical University Cancer Hospital - Nanning
- Shanghai East Hospital - Shanghai
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology - Wuhan
- CHU de Bordeaux - Pessac
- Fondazione IRCCS Istituto Nazionale dei Tumori - Milan
- Istituto Nazionale Tumori Fondazione G. Pascale - Naples
- Sarawak General Hospital - Sarawak
- Hospital Universitario Virgen del Rocio - Seville
- Kaohsiung Medical University Chung-Ho Memorial Hospital - Kaohsiung City
- China Medical University Hospital - Taichung
- Taipei Veterans General Hospital - Taipei
Victoria
- Monash Health - Clayton
- Alfred Health - Melbourne
Missouri
- Siteman Cancer Center - St Louis
Tennessee
- Tennessee Oncology, PLLC - Greco-Hainsworth Centers for Research - Nashville
Texas
- The University of Texas, MD Anderson Cancer Center - Houston
New South Wales
- Westmead Hospital - Sydney
South Australia
- ICON Cancer Center - Kurralta Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-02-18 |
| Est. Completion | 2026-08 |
| Phase | Phase 2 |
What the registry record for NCT06727565 still lists
NCT06727565 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 116-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (14% lower).
The record links to 1 condition, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.
NCT06727565 names 20 study sites across 7 states, led by Other, Victoria, Missouri.
Frequently Asked Questions
What is clinical trial NCT06727565 about?
NCT06727565 is a clinical study titled "Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Substudy-01". Master protocol: The main goal of this master clinical study is to evaluate the efficacy and safety of multiple novel combination therapies in participants with head and neck squamous cell carcinoma (HNSCC) in various substudies. Substudy-01 will evaluate the efficacy and safety of novel combinatio...
What is the current status of trial NCT06727565?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2025-02-18. Estimated completion is 2026-08.
What conditions does trial NCT06727565 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma.
What interventions are being tested in trial NCT06727565?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Zimberelimab (DRUG), Domvanalimab (DRUG).
Who is sponsoring clinical trial NCT06727565?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06727565 being conducted?
This trial has 20 study locations across Missouri, Tennessee, Texas, New South Wales, South Australia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06727565's enrollment target sits among peer trials
100 40th of 124 higher than 84 of 124 other Head and Neck Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma 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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