AK112 Plus AP Regimen for Operable Locally Advanced Head and Neck Squamous Cell Carcinoma

NCT06537011 | Not Yet Recruiting Phase 2

• 1 other identifier: AK112-II-020
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

This exploratory phase II study is designed to enroll patients with operable locally advanced head and neck squamous cell carcinoma, to observe the efficacy and safety of AK112 combined with chemotherapy as neoadjuvant therapy on them.

Conditions

Neoadjuvant Therapy of Operable Locally Advanced Head and Neck Squamous Cell Carcinoma

Keywords

neoadjuvant therapy,AK112,advanced head and neck squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• EFS

  The time between the onset of treatment till disease progression, discontinuation of treatment for any reason, or death

  2 years

Secondary Outcomes (3)

• pCR

  3 cycles of treatment(1.5months)

• OS

  2 years

• MPR

  3 cycles of treatment(1.5months)

Study Arms (1)

AK112 combined with AP neoadjuvant therapy

EXPERIMENTAL

Three cycles of AK112 were given before operation every 3 weeks on D 1, D 22 and D 43, while AP regimen was given every 3 weeks on D 1, D 22 and D 43, respectively.

Drug: AK112

Interventions

AK112 DRUG

1. The patients are given AK112 combined with AP regimen every 3 weeks for 3 cycles before operation. 2. After the neoadjuvant therapy ,the patients will be assessed and be commanded surgery. 3.4-6 weeks after the surgery, the patients will be given chemoradiotherapy or radiotherapy alone decided on the conditon after surgery. 4.The participants will receive AK112 for 14 cycles after surgery.

AK112 combined with AP neoadjuvant therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years, regardless of sex;
• histological diagnosis of squamous cell carcinoma in oral cavity,oropharynx, hypopharynx or laryngeal;
• preoperative evaluation turns to be operatable;
• locally advanced, according to the American Joint Committee on Cancer ( AJCC -RSB- guidelines, 8th edition),HPV status is determined by p16 immunohistochemistry (IHC);
• Have not received prior treatment for head and neck squamous cell carcinoma;
• Have at least one evaluable target lesion according to RECIST version 1.1;
• ECOG physical condition 0-1 point;
• The function of the major organs is normal, which meets the following criteria(not receiving blood transfusion in 14 days):
• a. Hb(hemoglobin)≥90g/L:b. ANC(Neutrophils)≥1.5x109/L; c. PLT(platelet)≥80x109／L；
• The biochemical tests should meet the following criteria:
• a.BIL(bilirubin)\< 1.25 times the upper limit of normal (ULN); b.ALT(Alanine aminotransferase) and AST(Aspartate aminotransferase)\<2.5xULN; c.Serum CR(creatinine) ≤ ULN, endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gaut formula) ;
• Sign a written informed consent form before performing any test related activities;
• The researchers judged that they were able to comply with the study protocol;
• Pregnancy test (for fertile women) was negative at screening;
• Fertile male patients as well as fertile female patients at risk of fertility and pregnancy had to agree to use 2 contraceptive methods throughout the study period (at least one of which was considered to be an efficient contraceptive method) .

You may not qualify if:

• Previously received immunotherapy with anti-PD-1(programmed cell death receptor-1), anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies (including ipilimumab) or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways;
• Previously received prior chemotherapy or antiangiogenic therapy;
• Received major surgery ≤4 weeks before admission;
• Carrying any active autoimmune disease or history of autoimmune disease'
• Previous or concurrent getting cancers (except those that have been cured and have survived cancer-free for more than 5 years, such as skin basal-cell carcinoma, cervical carcinoma in situ, and papillary thyroid cancer) .
• Uncontrollable clinical symptom or disease of the heart;
• Within 14 days before the administration of the study drug, subjects who were required to undergo systemic therapy with corticosteroid (\> 10 mg daily prednisone efficacy dose) or other immunosuppressive agents, in the absence of active autoimmune disease, adrenal hormone replacement with inhaled or topical steroids and a therapeutic dose of prednisone \> 10 mg/day was allowed;
• Active infection requiring treatment;
• Patients with congenital or acquired immunodeficiency(such as HIV),active hepatitis B (HBV-DNA ≥104 copies/ml or 2000 IU/ml) , or hepatitis C (HCV-RNA was above the lower limit of detection);
• The patient has received other cancer specialised treatment;
• The live vaccine was administered within 4 weeks before starting the study;
• Known history of psychotropic substance abuse, alcohol or drug abuse;
• Pregnant or lactating female;
• The researchers determined that the subjects had other factors that could have led them to stop the study mid-course, such as having a serious medical condition (including mental illness) that required combined treatment, and severe abnormalities in laboratory tests, family or social factors that may affect the safety of the subject or the collection of experimental data;
• A patient who is considered by the surgeon to be inoperable;

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Central Study Contacts

kunyu yang, doctor

CONTACT

13429829986; wenlu@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 30, 2028
• Last Updated: August 6, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share