Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Substudy-01
NCT ID: NCT06727565
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2025-02-18
2026-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Group A: Domvanalimab (DOM) + Zimberelimab (ZIM) + Platinum-based Chemotherapy
Participants will receive DOM + ZIM + platinum-based chemotherapy (paclitaxel + carboplatin).
Domvanalimab
Administered intravenously
Zimberelimab
Administered intravenously
Paclitaxel
Administered intravenously
Carboplatin
Administered intravenously
Treatment Group B: Zimberelimab (ZIM) + Platinum-based Chemotherapy
Participants will receive ZIM + platinum-based chemotherapy (paclitaxel + carboplatin).
Zimberelimab
Administered intravenously
Paclitaxel
Administered intravenously
Carboplatin
Administered intravenously
Interventions
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Domvanalimab
Administered intravenously
Zimberelimab
Administered intravenously
Paclitaxel
Administered intravenously
Carboplatin
Administered intravenously
Eligibility Criteria
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Inclusion Criteria
* No prior systemic therapy for r/m HNSCC. Individuals who had disease progression or recurrence more than 6 months after the last dose of curative intent systemic platinum-containing therapy for locoregionally advanced disease are eligible.
* At least 1 measurable lesion by computed tomography or magnetic resonance imaging that qualifies as a RECIST v1.1 target lesion at baseline.
* Have adequate tumor tissue samples preferably from lesions not irradiated prior to biopsy (acceptable from irradiated lesions if disease progression has been demonstrated in such lesions) to submit for central testing.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Known results from human papillomavirus (HPV) status test (p16 expression) for oropharyngeal carcinoma defined as p16 testing.
* Have an active second malignancy or have had an active second malignancy within 3 years prior to enrollment.
* Have known active central nervous system (CNS) metastases. Individuals with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to enrollment and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastasis and are not requiring use of steroid for at least 14 days prior to the first dose of study drugs.
Exclusion Criteria
* Have disease that is suitable for any local therapies with curative intent.
* Individuals who had disease progression or recurrence within 6 months after the last dose of curative intent systemic platinum-containing therapy for locoregionally advanced disease.
* Have a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Have an active autoimmune disease that required systemic treatment in the past 2 years. (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
* Prior treatment with any of the following within the specific time frame prior to the first dose of study drug:
* Major surgery for any cause or significant traumatic injury within 4 weeks prior to the first dose of study drug. Individuals must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study drug.
* Any noninvestigational anticancer therapy (chemotherapy, biologic therapy, targeted therapy, hormone therapy, or immunotherapy, etc) within 4 weeks prior to the first dose of study drug. Concurrent use for noncancer related condition (eg, hormone replacement therapy) is acceptable.
* Any investigational drugs (drugs not marketed for any indication) within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of study drug.
* Radiation therapy within 2 weeks prior to the first dose of study drug. Individuals must have recovered to Grade ≤ 1 from all radiation-related toxicities, not requiring corticosteroid, and have not experienced radiation pneumonitis.
* Received prior treatment with any anti-PD-1/PD-L1, anti-TIGIT, or other immune checkpoint inhibitors.
* Currently receiving chronic systemic steroids (\> 10 mg/day prednisone or its equivalent). Use of topical, inhalational, intranasal, intraocular steroids, and use as premedication for hypersensitivity reactions (eg, IV contrast allergy) are permitted.
18 Years
ALL
No
Sponsors
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Arcus Biosciences, Inc.
INDUSTRY
Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Siteman Cancer Center
St Louis, Missouri, United States
Tennessee Oncology, PLLC - Greco-Hainsworth Centers for Research
Nashville, Tennessee, United States
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
Monash Health
Clayton, Victoria, Australia
Alfred Health
Melbourne, Victoria, Australia
ICON Cancer Center
Kurralta Park, , Australia
Westmead Hospital
Sydney, , Australia
Sichuan Cancer Hospital
Chengdu, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Guangxi Medical University Cancer Hospital
Nanning, , China
Shanghai East Hospital
Shanghai, , China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, , China
CHU de Bordeaux
Pessac, , France
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, , Italy
Sarawak General Hospital
Sarawak, , Malaysia
Hospital Universitario Virgen del Rocio
Seville, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, , Taiwan
Barts Health NHS Foundation Trust
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
Countries
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Central Contacts
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Gilead Clinical Study Information Center
Role: CONTACT
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2024-513121-22
Identifier Type: OTHER
Identifier Source: secondary_id
GS-US-699-7184-01
Identifier Type: -
Identifier Source: org_study_id