Actively Recruiting
A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)
Led by Akeso · Updated on 2024-11-14
510
Participants Needed
2
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 \[Combined Positive Score (CPS) greater than or equal to 1\].
CONDITIONS
Official Title
A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Histologically confirmed recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) located in oropharynx, oral cavity, hypopharynx, or larynx, not curable by local therapies
- For oropharyngeal cancer, results available from human papillomavirus (HPV) testing
- No prior systemic treatment for R/M HNSCC
- At least one measurable noncerebral lesion according to RECIST 1.1
- Tumor is PD-L1 positive with a combined positive score (CPS) of 1 or higher
- Adequate organ function
- Agreement to use effective contraception during and for 120 days after last dose if of reproductive potential
- Able to comply with all study participation requirements
You will not qualify if you...
- Squamous cell carcinoma of primary sites such as nasopharynx, nasal cavity, sinuses, salivary glands, thyroid or parathyroid, skin, or unknown primary origin
- Other malignant tumors within 5 years prior to enrollment
- Significant risk of bleeding as assessed by investigator
- Evidence of major blood vessel invasion, tumor invading organs, risk of fistula, or major blood vessel encasement increasing bleeding risk
- Known active central nervous system (CNS) metastases
- Symptomatic pleural, pericardial effusion, or ascites requiring repeated drainage
- Prior immunotherapy including checkpoint inhibitors or immune cell therapy
- Radiation therapy for head or neck within 8 weeks or palliative radiation elsewhere within 3 weeks prior to enrollment
- History of severe bleeding tendency or coagulation dysfunction
- History of myocarditis, cardiomyopathy, or malignant arrhythmia
- History of arterial or venous thromboembolism, transient ischemic attacks, strokes, hypertensive crises, or hypertensive encephalopathy within 6 months
- Pregnant or breastfeeding female
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
2
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
Research Team
W
Wenting Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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