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Compares treatment options for Head and Neck Squamous Cell Carcinoma
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)
ClinicalTrials.gov ID: NCT06601335
What this study is testing
What is AK117 in combination with AK112?
AK117 in combination with AK112 is an investigational medicine, being studied as a potential treatment for head and neck squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Be able and willing to provide written informed consent.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Have a life expectancy of at least 3 months.
- Has histologically confirmed diagnosis of R/M HNSCC primarily located in oropharynx, oral cavity, hypopharynx, or larynx, which is considered...
- Participants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status.
You likely can't join if
- Has squamous cell carcinoma of the primary site, such as nasopharynx, nasal cavity, sinuses, salivary glands, thyroid or parathyroid, skin, or of...
- Had other malignant tumors within the 5 years prior to enrollment.
- Has a significant risk of bleeding assessed by the investigator based on imaging.
- Radiologically documented evidence of major blood vessel invasion or tumor invading organs or there is a risk of esophagotracheal or esophagopleural...
- Has known active central nervous system (CNS) metastases.
- Has pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
See the full eligibility criteria
- Be able and willing to provide written informed consent.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Have a life expectancy of at least 3 months.
- Has histologically confirmed diagnosis of R/M HNSCC primarily located in oropharynx, oral cavity, hypopharynx, or larynx, which is considered incurable by local therapies.
- Participants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status.
- No prior systemic treatment for R/M HNSCC.
- At least one measurable noncerebral lesion according to RECIST 1.1.
- PD-L1 positive (CPS ≥ 1).
- Has adequate organ function.
- All people 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.
- Able to to comply with all requirements of study participation (including all study procedures).
- 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.
- Had other malignant tumors within the 5 years prior to enrollment.
- Has a significant risk of bleeding assessed by the investigator based on imaging.
- 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...
- Has known active central nervous system (CNS) metastases.
- Has pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
- Previously received immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, and any other treatments targeting the immune mechanisms of tumors.
- 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.
- Has a history severe bleeding tendency or coagulation dysfunction.
- Has a history myocarditis, cardiomyopathy, and malignant arrhythmia.
- 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.
- Pregnant or lactating female.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China; Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.