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Trial Title:
A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)
NCT ID:
NCT06601335
Condition:
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
AK117 in combination with AK112
Description:
Following a predefined dose and date.
Arm group label:
AK117 in combination with AK112
Intervention type:
Drug
Intervention name:
Placebo in combination with Pembrolizumab
Description:
Following a predefined dose and date.
Arm group label:
Placebo in combination with Pembrolizumab
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].
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Country:
China
Start date:
October 2024
Completion date:
October 2027
Lead sponsor:
Agency:
Akeso
Agency class:
Industry
Source:
Akeso
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06601335
