Comparing AK112 and AK117 to Pembrolizumab for Head and Neck Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: wenting01.li@akesobio.com
• Phone: 18116403289

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Telisotuzumab Adizutecan with Pembrolizumab as first-line treatment for recurrent or metastatic head and neck cancer

  This study tests a combination treatment to see if it helps people with newly diagnosed recurrent or metastatic head and neck squamous cell carcinoma who express the c-Met protein.

  Recruiting at 5 sites Phase 2 AbbVie · Duarte, California and 4 other locations · NCT07744126

• CUE-101 with pembrolizumab for locally advanced HPV‑16 positive oropharyngeal cancer

  This trial tests whether CUE-101 alone or combined with pembrolizumab before definitive therapy helps people with newly diagnosed, locally advanced HPV‑16 positive oropharyngeal cancer who are HLA‑A*02:01 positive.

  Recruiting Phase 2 Yale University · New Haven, Connecticut · NCT07172256

• Investigating ALE.P02 for treating specific solid tumors in adults

  This study is testing a new treatment called ALE.P02 to see if it can safely help adults with advanced solid tumors that have a specific marker called Claudin-1.

  Recruiting at 39 sites Phase 1/2 Alentis Therapeutics AG · Scottsdale, Arizona and 40 other locations · NCT06747585

• Combining Pembrolizumab with Chemotherapy for Advanced Head and Neck Cancer

  This study is testing whether adding a drug called pembrolizumab to standard chemotherapy can help people with advanced head and neck cancer respond better to treatment.

  Recruiting Phase 3 Beijing Tongren Hospital · Beijing, Beijing Municipality · NCT06102395

• MQ710 with or without pembrolizumab for advanced skin and other solid tumors

  This will test different doses of MQ710, alone or together with pembrolizumab, in adults with advanced or recurrent solid tumors (including skin cancers) to find a safe dose with mild side effects.

  Recruiting at 5 sites Phase 1 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT05859074

• Combining TU2218 with KEYTRUDA for advanced solid tumors

  This study is testing a new treatment combining TU2218 and KEYTRUDA to see if it can help people with advanced solid tumors who haven't responded to other therapies.

  Recruiting at 8 sites Phase 1/2 TiumBio Co., Ltd. · San Antonio, Texas and 10 other locations · NCT05784688

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.