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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

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2063200044
Enrollment
23
Registered
2021-01-14
Start date
2021-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Interventions

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

Sponsors

Fujiwara Toshiyoshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
safety observation

Secondary

MeasureTime frame
efficacy tumor assessment, observation

Contacts

Public ContactClinical trials information

Chugai Pharmaceutical Co., Ltd.

clinical-trials@chugai-pharm.co.jp+81-120-189-706

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026