Study on New Treatment Combinations for Head and Neck Squamous Cell Carcinoma
Sponsor: Gilead Sciences
ClinicalTrials ID:NCT06727565
This clinical trial is exploring the safety and effectiveness of new treatment combinations for patients with head and neck squamous cell carcinoma (HNSCC). The study includes different substudies to test these treatments in various patient groups.
Patient Parameters
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Program Overview
The main goal of this study is to test the safety and effectiveness of several new treatment combinations for head and neck squamous cell carcinoma (HNSCC). The study will start with a specific group of patients whose cancer has returned or spread and who have not had prior systemic treatment. New substudies may be added in the future to include different patient groups. The first substudy will compare the effects of two treatment combinations: one with the drugs domvanalimab (DOM) and zimberelimab (ZIM) plus chemotherapy, and the other with ZIM plus chemotherapy alone. About 100 patients are expected to participate in this initial substudy.
Description
This study is designed to test new treatment combinations for head and neck squamous cell carcinoma (HNSCC). It will begin with a substudy focusing on patients whose cancer has returned or spread and who have not received prior systemic treatment. This substudy will compare two treatment regimens: one combining the drugs domvanalimab (DOM) and zimberelimab (ZIM) with chemotherapy, and the other combining ZIM with chemotherapy alone. The primary goal is to see how effective these combinations are in treating the cancer. The study plans to enroll about 100 participants in this initial substudy. Additional substudies may be added later to test other drugs and treatment combinations as more data becomes available.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with recurrent or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx that cannot be cured with local treatments.
- No previous systemic therapy for recurrent or metastatic HNSCC, unless the cancer returned more than 6 months after completing a platinum-based therapy.
- At least one tumor that can be measured by a scan.
- Able to provide a tumor sample for testing, preferably from a non-irradiated area.
- Good overall health with an ECOG performance status of 0 or 1.
- Known HPV status for oropharyngeal cancer.
Exclusion Criteria
- Have nasopharyngeal cancer, squamous cell carcinoma of unknown primary, skin, paranasal sinuses, or salivary gland.
- Have cancer that can be treated with local therapies aimed at curing it.
- Cancer returned within 6 months after completing a platinum-based therapy.
- History of lung diseases like pneumonitis that required steroids.
- Active autoimmune disease needing treatment in the past 2 years, except for replacement therapies.
- Recent major surgery or significant injury within 4 weeks before starting the study.
- Recent cancer treatments or investigational drugs within 4 weeks before starting the study.
- Recent radiation therapy within 2 weeks before starting the study.
- Previous treatment with certain immune therapies.
- Currently on high-dose steroids.
- Unresolved side effects from previous cancer treatments, except for certain conditions like hair loss.
- Have another active cancer or had one within the last 3 years.
- Have active brain metastases, unless previously treated and stable for at least 4 weeks.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Siteman Cancer Center | 63110 | Saint Louis | Missouri |
| Tennessee Oncology, PLLC - Greco-Hainsworth Centers for Research | 37203 | Nashville | Tennessee |
| The University of Texas, MD Anderson Cancer Center | 77030 | Houston | Texas |
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