Neoadjuvant Immunotherapy in Combination With Chemotherapy in Resectable Head and Neck Cancer:A Randomized, Phase II Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

A Randomized, Phase II Study of ivonescimab or cadonilimab or penpulimab in Combination With Cisplatin and Nab-paclitaxel in Patients With locally advanced head and neck squamous cell carcinoma (HNSCC) eligible for resection. This proposed study will evaluate the efficacy and safety of preoperative administration of ivonescimab or cadonilimab or penpulimab combined with chemotherapy in HNSCC who are eligible for resection.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Males and females; Age:18 to 75 years.

• Histologically or cytologically confirmed head and neck squamous cell carcinoma (HNSCC).

• Patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• No prior treatment for the cancer.

• Intention to undergo curative treatment.

• Patients with normal organ function and suitable for immunotherapy combined with chemotherapy and surgery:

• Adequate hematologic function (total white blood cell count ≥ 3.0×10\^9/L, absolute lymphocyte count ≥ 0.8×10\^9/L, absolute neutrophil count ≥ 1.5×10\^9/L, platelets ≥ 100×10\^9/L, hemoglobin ≥ 90g/L); Adequate hepatic function (bilirubin level ≤ 2 times the upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN); Adequate renal function (serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula), urine protein \<2+ on dipstick or \<1g in a 24-hour urine collection); Good cardiac function, i.e., normal or clinically insignificant abnormalities on electrocardiogram (ECG), echocardiogram showing a left ventricular ejection fraction (LVEF) ≥50%; Adequate coagulation function: International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times ULN; participants on anticoagulation treatment are eligible if the PT is within the therapeutic range of the anticoagulant;

• Blood pressure well controlled (defined as systolic blood pressure ≤ 150 mmHg and diastolic blood pressure ≤ 90 mmHg) with or without antihypertensive medication, and no change in antihypertensive treatment within 1 week before the first dose of study medication.

• Patients with HBV infection capable of having detectable HBV DNA levels (≥10IU/mL or above the limit of quantitation) (manifested as positive for hepatitis B surface antigen (HbsAg) and/or hepatitis B core antibody (anti-HBc)) must receive antiviral therapy according to clinical practice at the site before randomization to ensure adequate viral suppression. Patients must maintain antiviral therapy during the study and for 6 months after the last dose of study treatment. Patients who are anti-HBc positive but do not have detectable HBV DNA (\<10IU/mL or below the limit of quantitation) are not required to receive antiviral therapy unless their HBV DNA levels exceed 10IU/mL or the limit of quantitation during treatment.

⁃ Women of childbearing potential (15-49 years old) must have a negative pregnancy test within 7 days before starting treatment; patients of childbearing potential must agree to use effective contraception to ensure they do not become pregnant during the study period and for 3 months after stopping treatment.

⁃ Participants voluntarily join the study, sign an informed consent form, have good compliance, and cooperate with follow-up.

Locations
Other Locations
China
West China Hospital
RECRUITING
Chengdu
Contact Information
Primary
Lei Liu, M.D.
liuleihx@gmail.com
Liu
Backup
Yuanyuan Zeng, M.D.
zengyuanyuanpower@163.com
+86-028-85422114
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 90
Treatments
Experimental: Ivonescimab in combination with Nab-paclitaxel + Cisplatin
Neoadjuvant:~Patients receive ivonescimab in combination with nab-paclitaxel + cisplatin for 3 cycles before surgery.~Surgery:~Within a 2-6 week window post induction, tumor imaging will be followed by surgical resection.~Adjuvant:~pCR: Patients receive adjuvant ivonescimab for 16 cycles.~no pCR:~Low/ Medium Risk:~Patients will be treated with intensity modulation radiation therapy (IMRT) alone. Once radiotherapy is complete these patients will receive adjuvant ivonescimab for 16 cycles~High Risk:~All patients will be treated with IMRT concurrent with cisplatin or other standard of care chemoradiotherapy regimen. Once chemoradiotherapy is complete these patients will receive adjuvant ivonescimab for 16 cycles.
Experimental: Cadonilimab in combination with Nab-paclitaxel + Cisplatin
Neoadjuvant:~Patients receive cadonilimab in combination with nab-paclitaxel + cisplatin for 3 cycles before surgery.~Surgery:~Within a 2-6 week window post induction, tumor imaging will be followed by surgical resection.~Adjuvant:~pCR: Patients receive adjuvant cadonilimab for 16 cycles.~no pCR:~Low/ Medium Risk:~Patients will be treated with intensity modulation radiation therapy (IMRT) alone. Once radiotherapy is complete these patients will receive adjuvant cadonilimab for 16 cycles~High Risk:~All patients will be treated with IMRT concurrent with cisplatin or other standard of care chemoradiotherapy regimen. Once chemoradiotherapy is complete these patients will receive adjuvant cadonilimab for 16 cycles.
Experimental: Penpulimab in combination with Nab-paclitaxel + Cisplatin
Neoadjuvant:~Patients receive penpulimab in combination with nab-paclitaxel + cisplatin for 3 cycles before surgery.~Surgery:~Within a 2-6 week window post induction, tumor imaging will be followed by surgical resection.~Adjuvant:~pCR: Patients receive adjuvant penpulimab for 16 cycles.~no pCR:~Low/ Medium Risk:~Patients will be treated with intensity modulation radiation therapy (IMRT) alone. Once radiotherapy is complete these patients will receive adjuvant penpulimab for 16 cycles~High Risk:~All patients will be treated with IMRT concurrent with cisplatin or other standard of care chemoradiotherapy regimen. Once chemoradiotherapy is complete these patients will receive adjuvant penpulimab for 16 cycles.
Sponsors
Leads: Lei Liu

This content was sourced from clinicaltrials.gov