Phase I Study of Combination Therapy with OBP-301, Atezolizumab and chemoradiotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck Cancer

JRCT ID: jRCT2063200044

Registered date:14/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Head and Neck Cancer
• Date of first enrollment: 01/12/2021
• Target sample size: 23
• Study type: Interventional

Intervention(s)

OBP-301:Specified dose is adminiistered into tumors endoscopically or transdermally.
Atezolizumab:1200 mg IV infusion Q3W
Cisplatin:Specified dose, IV

Outcome(s)

Primary Outcome

safety
observation

Secondary Outcome

efficacy
tumor assessment, observation

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Patients with the oral cavity, oropharynx, larynx, or hypopharynx histologically or cytologically confirmed who are unresectable or wishing organ preservation
- When oropharynx cancer, HPV status is determined
- Definitive chemoradiotherapy of CDDP and IMRT are indicated.
- ECOG Performance Status (PS) is 0 to 1.

Exclude criteria

- The stage for primary tumor or cervical nodes is unknown.
- Prior treatment with definitive local therapy or systemic therapy for the head and neck cancer.
- Prior treatment with radiotherapy over the cranial base to clavicle.

Related Information

• Primary Sponsor: Fujiwara Toshiyoshi