NIPH Clinical Trials Search

Phase I study of ipilimumab injection into lymph node for patients with head and neck cancer

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	head and neck squqmous cell carcinoma
Date of first enrollment	15/12/2025
Target sample size	10
Countries of recruitment
Study type	Interventional
Intervention(s)	Ipilimumab (Bristol-Myers Squibb, trade name Yervoy): Injected into lymph nodes under ultrasound guidance on Day 1 and Day 8. The dose is calculated as 0.003 mg/mm3 of lymph node volume, determined using the folowing formula: long axis x short axis x short axis x 1/2. Nivolumab (Ono Pharmaceutical Co., trade name Opdivo): Administered by intravenous infusion at a dosage of 240 mg every 2 weeks.

Outcome(s)

Primary Outcome	Grades and their incidence rates of adverse events observed 8 weeks after Ipilimumab LDDS and Nivolumab intravenous administration
Secondary Outcome	The grades and incidence rates of adverse events observed 12 weeks after or at the discontinuation of Ipilimumab LDDS and Nivolumab intravenous administration Observation of injection site of Ipilimumabl by Lymphatic Drug Delivery System Objective response rate and tumor shrinkage rate at 8 weeks Progression-free survival rate at 12 weeks

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1) Patients who have provided written informed consent to participate in the study 2) Patients aged 18 years or older at the time of consent 3) Patients diagnosed histologically with squamous cell carcinoma of the head and neck 4) Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 5) Patients with prior treatment history involving an immune checkpoint inhibitor and a platinum agent 6) Patients with clinically diagnosed cervical lymph node metastases meeting the following criteria for injection of ipilimumab: [Size] Superficial lymph nodes: shortest diameter approximately >=1 cm Deep lymph nodes: shortest diameter approximately >=2 cm [Imaging findings] The target lymph node can be clearly visualized by ultrasonography, and a safe puncture route can be secured. [Exclusion criteria] Lymph nodes meeting any of the following conditions are excluded: Lymph nodes with marked capsular rupture Lymph nodes continuous with a skin ulcer Lymph nodes judged to be adjacent to or involving major vessels Lymph nodes consisting predominantly of extensive necrotic tissue with few viable tumor cells 7) Patients with measurable lesions per RECIST criteria in addition to the lesions planned for Ipilimumab injection
Exclude criteria	1) Patients with uncontrolled central nervous system metastases 2) Patients with high risks of tumor-induced bleeding or airway obstruction 3) Patients with a history of other malignancies, except those who achieved complete remission over two years prior to the study 4) Patients with active autoimmune diseases (Patients with Type 1 diabetes, endocrine disorders requiring only hormone replacement therapy, or skin conditions not requiring systemic treatment are acceptable) 5) Patients with a history of hypersensitivity to anti-Programmed Death-1 antibodies, or those with prior immune-related adverse events that contraindicate retreatment 6) Patients unable to maintain abstinence or employ effective contraception during the study period 7) Patients receiving continuous systemic steroid (exceeding 10 mg/day in prednisone equivalents) or immunosuppressive therapy 8) Pregnant or breastfeeding patients 9) Patients with severe hepatic or renal dysfunction 10) Patients considered unsuitable for the study by principal investigator