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NCT06727565 | RECRUITING | Head and Neck Squamous Cell Carcinoma

Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma.
Sponsor:

Gilead Sciences

Brief 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.

Condition or disease

Head and Neck Squamous Cell Carcinoma

Intervention/treatment

Domvanalimab

Zimberelimab

Paclitaxel

Carboplatin

Phase

PHASE2

Detailed Description:

This platform study will begin with a substudy targeting first-line (1L) recurrent or metastatic (r/m) HNSCC regardless of programmed cell death ligand 1 (PD-L1) expression status (Substudy-01), and new substudies may be added in the future targeting different study populations of HNSCC. All substudies evaluating additional drugs will be added in a staggered manner when relevant nonclinical and/or clinical data become available. Additional drugs may also be added to Substudy-01 in the future. (GS-US-699-7184-01) 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. Substudy-01 planned enrollment is approximately 100.

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 2 Platform Study of Novel Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma
Actual Study Start Date : 2025-02-18
Estimated Primary Completion Date : 2026-08
Estimated Study Completion Date : 2026-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma.

Location Details

NCT06727565

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Missouri

Siteman Cancer Center

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, Tennessee

Tennessee Oncology, PLLC - Greco-Hainsworth Centers for Research

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

The University of Texas, MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

Australia, Victoria

Monash Health

Clayton, Victoria, Australia, 3168

RECRUITING

Australia,

ICON Cancer Center

Parking Park, Australia, 5037

RECRUITING

Australia,

Westmead Hospital

Sydney, Australia, 2145

RECRUITING

China,

Sichuan Cancer Hospital

Chengdu, China, 610040

RECRUITING

China,

Zhejiang Cancer Hospital

Hangzhou, China, 310005

RECRUITING

China,

Guangxi Medical University Cancer Hospital

Nanning, China, 530012

RECRUITING

China,

Shanghai East Hospital

Shanghai, China, 200120

RECRUITING

China,

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China, 430030

RECRUITING

France,

Bordeaux CHU

Pessac, France, 33604

RECRUITING

Italy,

G. Pascale National Cancer Institute

Napoli, Italy, 80131

RECRUITING

Spain,

Virgen del Rocio University Hospital

Sevilla, Spain, 41013

RECRUITING

Taiwan,

Medical University Chunng-Hospital

City fast, Taiwan, 80756

RECRUITING

Taiwan,

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

composed, Taiwan, 833

RECRUITING

Taiwan,

China Medical University Hospital

Taichung, Taiwan, 40402

RECRUITING

Taiwan,

Taipei Veterans General Hospital

Taipei City, Taiwan, 11217

RECRUITING

United Kingdom,

Barts Health NHS Foundation Trust

London, United Kingdom, Ec1a 7be

RECRUITING

United Kingdom,

The Royal Marsden NHS Foundation Trust

London, United Kingdom, SW10 9NH