This is a phase 3 study. All subjects arerecurrent or metastatic head and neck squamousCell Carcinoma (R/M HNSCC), Eastern Cooperative Oncology Group (ECOG) performance status0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 combinedwith AK117 versus pembrolizumab combined with placebo in patients with R/M HNSCC whosetumors have programmed cell death-ligand 1 (PD-L1) positive [Combined Positive Score(CPS) greater than or equal to 1].
Not Provided
Drug: AK117 in combination with AK112
Following a predefined dose and date.
Drug: Placebo in combination with Pembrolizumab
Following a predefined dose and date.
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.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Wenting Li
18116403289
wenting01.li@akesobio.com
Not Provided