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Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Substudy-01

Name: Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Substudy-01 — clinical trial record (NCT06727565)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: VELOCITY-HNSCC

StatusActive, Not Recruiting

PhasePhase 2

SponsorGilead Sciences

Started2025-02-18

View on ClinicalTrials.gov ↗

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.

Amendment history 3 changes detected by DataLookout

2026-09-04

Final enrollment: 39 participants (planned 100)

2026-09-04

Primary completion pushed: 2026-08 → 2027-03

2026-09-04

Completion pushed: 2026-08 → 2027-03

Trial Details

NCT Number	NCT06727565
Lead Sponsor	Gilead Sciences Collaborators: Arcus Biosciences, Inc.
Conditions	Head and Neck Squamous Cell Carcinoma
Enrollment	39 participants
Start Date	2025-02-18
Primary Completion	2027-03 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2026-09-03