A phase III study of nivolumab and ipilimumab(ONO-4538-42/CA209-651)

Phase 3

Completed

• Conditions: Head and neck cancer

• Registration Number: JPRN-jRCT2080223334
• Lead Sponsor: ONO PHARMACEUTICAL CO.,LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-29
• Study Completion: 2022-09-22
• Results First Posted: 2022-12-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 947

Inclusion Criteria

1. Histologically confirmed metastatic or recurrent squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx & larynx) that is not amenable to curative therapy.
2. No prior systemic cancer therapy for recurrent or metastatic disease (except if chemotherapy was part of multimodal treatment completed 6 months prior to enrolment).
3. Measurable disease detected by imaging exam (CT or MRI).
4. Have tumor tissue for PD-L1 expression testing, and for oropharyngeal cancer have results from testing of HPV-p16 status.

Exclusion Criteria

1. Metastatic or recurrent carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma originating from skin and salivary glands or non squamous histologies (eg. mucosal melanoma).
2. Prior treatment with anti PD-1, anti PD-L1, anti CTLA-4 antibody or any other antibody or drugs targeting T cell co-stimulation or checkpoint pathways, or cetuximab or EGFR inhibitors in any treatment setting.
3. Patients with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder.
4. Inadequate hematologic, renal or hepatic function.

Study & Design

• Study Type: Interventional
• Study Design: Not specified