Anti-PD-1 Therapy in Recurrent and Metastatic Head and Neck Squamous Cell Carcinoma (NCT07751289) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Anti-PD-1 Therapy in Recurrent and Metastatic Head and Neck Squamous Cell Carcinoma
217 participantsStarted 2026-08-01
Plain-language summary
The goal of this clinical trial is to determine whether a perioperative PD-1 antibody-based treatment strategy, consisting of neoadjuvant PD-1 antibody plus chemotherapy followed by adjuvant PD-1 antibody after surgery, improves outcomes compared with the current standard treatment in patients with resectable locally recurrent head and neck squamous cell carcinoma (HNSCC). The study will also evaluate the safety of this perioperative treatment approach.
The main questions it aims to answer are:
Does perioperative PD-1 antibody-based therapy improve event-free survival compared with the current standard treatment? What adverse events occur during treatment with neoadjuvant PD-1 antibody plus chemotherapy and adjuvant PD-1 antibody?
Researchers will compare a perioperative PD-1 antibody-based treatment strategy with the current standard treatment to determine which approach provides better clinical outcomes.
Participants will:
Be randomly assigned to one of two study groups. Receive either neoadjuvant PD-1 antibody plus chemotherapy followed by surgery and adjuvant PD-1 antibody, or undergo upfront surgery followed by standard postoperative treatment as indicated.
Visit the clinic regularly for physical examinations, blood tests, imaging assessments, and other study procedures.
Be followed after treatment to monitor disease status, treatment response, survival outcomes, and adverse events.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: 18 to 80 years old (inclusive).
. Primary Tumor: Histologically or cytologically confirmed head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma). Patients must have previously received surgery and/or radiotherapy.
. Diagnosis: Locally recurrent or metastatic disease confirmed by pathology and/or imaging.
. Clinical Stage: T1-4a, N0-2, M0 (AJCC TNM Staging System, 8th Edition), with no evidence of distant metastasis, and the recurrent lesion is assessed as surgically resectable.
. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
. Life Expectancy: Expected survival ≥ 6 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Immunotherapy: No significant contraindications to immunotherapy.
. Consent to Surgery: Willing to undergo surgical treatment.
Exclusion criteria
. Prior treatment with anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, CTLA-4 antibodies, or other drugs/antibodies targeting T-cell co-stimulation or checkpoint pathways.
. Presence of active severe autoimmune disease. Participants with conditions that are stable and do not require systemic immunosuppressive therapy are eligible, such as: Type I diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, and alopecia).
. Has a congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10⁴ copies/mL), or active hepatitis C (positive hepatitis C antibody and HCV-RNA above the lower limit of detection of the assay).
. Known allergy to the study drug or any of its excipients; or a history of severe allergic reactions to other monoclonal antibodies.
. Occurrence of any of the following within 6 months prior to randomization: myocardial infarction, severe/unstable angina pectoris, cardiac insufficiency of NYHA Class 2 or higher, clinically significant supraventricular or ventricular arrhythmias, or symptomatic congestive heart failure.
. Vaccination with a live vaccine within 4 weeks prior to the first dose of the study drug. Inactivated virus vaccines for seasonal influenza administered via injection are permitted; however, intranasal live attenuated influenza vaccines are not permitted.
. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
. Known history of psychoactive substance abuse or drug addiction.