RecruitingPhase 3NCT06601335

A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

A Randomized, Controlled, Multicenter Phase 3 Study of AK112 in Combination With AK117 Versus Pembrolizumab as First Line Treatment for a Programmed Cell Death-ligand 1 (PD-L1) Positive Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)


Sponsor

Akeso

Enrollment

510 participants

Start Date

Oct 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 3 study. All subjects arerecurrent or metastatic head and neck squamous Cell Carcinoma (R/M HNSCC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 combined with AK117 versus pembrolizumab combined with placebo in patients with R/M HNSCC whose tumors have programmed cell death-ligand 1 (PD-L1) positive \[Combined Positive Score (CPS) greater than or equal to 1\].


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 study is comparing two experimental immunotherapy drugs (AK112 + AK117) against the standard immunotherapy drug pembrolizumab in patients with head and neck squamous cell cancer that has returned or spread and cannot be cured with local treatments. **You may be eligible if...** - You have confirmed squamous cell carcinoma of the oropharynx, oral cavity, throat (hypopharynx), or voice box (larynx) that has returned or spread - You have not yet received any systemic (whole-body) treatment for this recurrent or metastatic cancer - You have at least one measurable tumour site (outside the brain) - Your tumour is PD-L1 positive (CPS ≥ 1, a marker measured by lab testing) - You are in good overall health (ECOG 0 or 1) - Your expected survival is at least 3 months - If you have oropharyngeal cancer, your HPV status has been tested **You may NOT be eligible if...** - Your cancer originated in the nose, sinuses, salivary glands, thyroid, skin, or from an unknown primary site - You had another cancer in the past 5 years - You have significant risk of severe bleeding from the tumour - You have not received prior systemic therapy but do not meet PD-L1 positivity threshold Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAK117 in combination with AK112

Following a predefined dose and date.

DRUGPlacebo in combination with Pembrolizumab

Following a predefined dose and date.


Locations(2)

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

Wuhan, Hubei, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

View Full Details on ClinicalTrials.gov

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NCT06601335


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