Comparing AK112 and AK117 to Pembrolizumab for Head and Neck Cancer

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)

This study is testing if a new combination treatment of AK112 and AK117 can work better than the standard drug pembrolizumab for people with advanced head and neck cancer.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 510 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Akeso (Industry-sponsored)
• Drugs / interventions: immunotherapy, radiation, pembrolizumab
• Locations: 2 sites (Wuhan, Hubei and 1 other locations)
• Trial ID: NCT06601335 on ClinicalTrials.gov

What this trial studies

This phase 3 study evaluates the efficacy and safety of a combination of AK112 and AK117 compared to pembrolizumab plus placebo in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). Participants must have a confirmed diagnosis of R/M HNSCC with PD-L1 positive tumors and an ECOG performance status of 0 or 1. The study aims to determine if the new combination therapy offers better outcomes than the standard treatment. Patients will be monitored for measurable lesions and overall health during the trial.

Who should consider this trial

Good fit: Ideal candidates include adults with recurrent or metastatic head and neck squamous cell carcinoma who have not received prior systemic treatment and have PD-L1 positive tumors.

Not a fit: Patients with non-PD-L1 positive tumors or those who have previously received systemic treatment for R/M HNSCC may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with recurrent or metastatic head and neck cancer.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, indicating potential for success in this novel combination.

Eligibility criteria

Inclusion Criteria:

1. Be able and willing to provide written informed consent.
2. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3. Have a life expectancy of at least 3 months.
4. Has histologically confirmed diagnosis of R/M HNSCC primarily located in oropharynx, oral cavity, hypopharynx, or larynx, which is considered incurable by local therapies.
5. Participants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status.
6. No prior systemic treatment for R/M HNSCC.
7. At least one measurable noncerebral lesion according to RECIST 1.1.
8. PD-L1 positive (CPS ≥ 1).
9. Has adequate organ function.
10. All subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.
11. Able to to comply with all requirements of study participation (including all study procedures).

Exclusion Criteria:

1. Has squamous cell carcinoma of the primary site, such as nasopharynx, nasal cavity, sinuses, salivary glands, thyroid or parathyroid, skin, or of unknown primary origin.
2. Had other malignant tumors within the 5 years prior to enrollment.
3. Has a significant risk of bleeding assessed by the investigator based on imaging.
4. Radiologically documented evidence of major blood vessel invasion or tumor invading organs or there is a risk of esophagotracheal or esophagopleural fistula, or major blood vessel encasement that the investigator determines will pose a significantly increased risk of bleeding.
5. Has known active central nervous system (CNS) metastases.
6. Has pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
7. Previously received immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, and any other treatments targeting the immune mechanisms of tumors.
8. Previously received radiation therapy for head or neck within 8 weeks prior to enrollment, received palliative radiation therapy for non-head or non-neck within 3 weeks prior to enrollment.
9. Has a history severe bleeding tendency or coagulation dysfunction.
10. Has a history myocarditis, cardiomyopathy, and malignant arrhythmia.
11. Has a history arterial or venous thromboembolism events, transient ischemic attacks, cerebrovascular accidents, hypertensive crises, or hypertensive encephalopathy occurred within 6 months prior to enrollment.
12. Pregnant or lactating female.

Where this trial is running

Wuhan, Hubei and 1 other locations

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Wenting Li

Conditions Head and Neck Squamous Cell Carcinoma