New drug cocktail aims to shrink head and neck tumors better than standard care

NCT ID NCT06727565

Disease control Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tests whether adding an experimental drug (domvanalimab) to a standard immunotherapy (zimberelimab) plus chemotherapy works better than the standard immunotherapy plus chemotherapy alone for people with head and neck cancer that has spread or come back. About 100 adults who have not had prior treatment for this stage of cancer will take part. The main goals are to see if the new combination shrinks tumors more often and helps keep cancer from growing longer.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

39 people

The number who actually took part.

Started

Feb 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Histologically or cytologically confirmed r/m squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies. * 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. Key Exclusion Criteria: * Individuals with nasopharyngeal cancer (any histology), squamous cell carcinoma of unknown primary tumors, skin (cutaneous squamous cell carcinoma), paranasal sinuses, and salivary gland. * 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. * Any unresolved toxicity (Grade ≥ 2) per National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 from prior anticancer therapy or surgical intervention, with the exception of alopecia, vitiligo, and the laboratory toxicities if the laboratory thresholds defined in the inclusion criteria are met. Individuals with Grade ≤ 2 neuropathy are eligible for this study. * 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. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck squamous cell carcinoma

Contacts and locations

Locations

Alfred Health

Melbourne, Victoria, 3004, Australia
Barts Health NHS Foundation Trust

London, EC1A 7BE, United Kingdom
CHU de Bordeaux

Pessac, 33604, France
Chang Gung Memorial Hospital, Linkou

Taoyuan, 33308, Taiwan
China Medical University Hospital

Taichung, 40402, Taiwan
Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy
Guangxi Medical University Cancer Hospital

Nanning, 530012, China
Hospital Universitario Virgen del Rocio

Seville, 41013, Spain
ICON Cancer Center

Kurralta Park, South Australia, 5037, Australia
Istituto Nazionale Tumori Fondazione G. Pascale

Naples, 80131, Italy
Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan
Monash Health

Clayton, Victoria, 3168, Australia
Sarawak General Hospital

Sarawak, 93586, Malaysia
Shanghai East Hospital

Shanghai, 200120, China
Sichuan Cancer Hospital

Chengdu, 610040, China
Siteman Cancer Center

St Louis, Missouri, 63110, United States
Taipei Veterans General Hospital

Taipei, 11217, Taiwan
Tennessee Oncology, PLLC - Greco-Hainsworth Centers for Research

Nashville, Tennessee, 37203, United States
The Royal Marsden NHS Foundation Trust

London, SW10 9NH, United Kingdom
The University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, 430030, China
Westmead Hospital

Sydney, New South Wales, 2145, Australia
Zhejiang Cancer Hospital

Hangzhou, 310005, China

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