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Phase I study of ipilimumab via Lymphatic Drug Delivery System for patients with recurrent or metastatic head and neck squamous cell carcinoma (IPI-LDDS 01 STUDY)

Phase I study of ipilimumab injection into lymph node for patients with head and neck cancer (IPI-LDDS 01 STUDY)

Kawakami Hisato

Tohoku University Hospital

1-1 Seiryo-machi,Aoba-ku,Sendai,Miyagi

kawakami_h@tohoku.ac.jp

Saijo Ken

Tohoku University Hospital

1-1 Seiryo-machi,Aoba-ku,Sendai,Miyagi

+81-22-717-7879

ken.saijo.d6@tohoku.ac.jp

Recruiting

Dec. 15, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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

Both

head and neck squqmous cell carcinoma

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.

Grades and their incidence rates of adverse events observed 8 weeks after Ipilimumab LDDS and Nivolumab intravenous administration

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

+81-22-718-0461

Nov. 21, 2025

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