A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

NCT06601335 | Recruiting Phase 3 DMC

• 1 other identifier: AK117-302
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 2

Brief 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 \[Combined Positive Score (CPS) greater than or equal to 1\].

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS is the time from randomization to death due to any cause.

  Up to approximately 2 years

Secondary Outcomes (6)

• Progression Free Survival (PFS)

  Up to approximately 2 years

• Objective Response Rate (ORR)

  Up to approximately 2 years

• Adverse Events (AEs)

  Up to approximately 2 years

• Cmax

  Up to approximately 2 years

• Cmin

  Up to approximately 2 years

Study Arms (2)

AK117 in combination with AK112

EXPERIMENTAL

Drug: AK117 in combination with AK112

Placebo in combination with Pembrolizumab

ACTIVE COMPARATOR

Drug: Placebo in combination with Pembrolizumab

Interventions

AK117 in combination with AK112 DRUG

Following a predefined dose and date.

AK117 in combination with AK112

Placebo in combination with Pembrolizumab DRUG

Following a predefined dose and date.

Placebo in combination with Pembrolizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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 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.
• Able to to comply with all requirements of study participation (including all study procedures).

You may not qualify if:

• 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 determines will pose a significantly increased risk of bleeding.
• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (2)

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

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Central Study Contacts

Wenting Li

CONTACT

18116403289; wenting01.li@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 19, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

CN (2)