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

An Open Label, Randomized, Two Arm Phase III Study of Nivolumab in Combination With Ipilimumab Versus Extreme Study Regimen (Cetuximab + Cisplatin/Carboplatin + Fluorouracil) as First Line Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)(ONO-4538-42/CA209-651)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223334

Enrollment

930

Registered

2016-09-29

Start date

2016-08-04

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

investigational material(s) Generic name etc : Nivolumab, Ipilimumab INN of investigational material : Nivolumab, Ipilimumab Therapeutic category code : 429 Other antitumor agents Dosage and Adminis

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
efficacy 1.Overall Survival (OS) in participants with PD-L1 expressing tumors 2.Progression Free Survival (PFS) in pariticipants with PD-L1 expressing tumors	—

Secondary

Measure	Time frame
efficacy 1.OS (overall survival) in participants with PD-LI expressing tumors with different cut off value 2.ORR (objective response rate) in all participants and those with PD-L1 expressing tumors 3.Duration of Response (DOR) in all participants and those with PD-L1 expressing tumors 4.PFS (Progression Free Survival) in all participants and those with PD-L1 expressing tumors	—

Countries

Asia except Japan, Europe, Japan, Middle East, North America, Oceania, South America

Outcome results

None listed

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