Adjuvant immunotherapy after salvage surgery in head and neck squamous cell carcinoma: phase 2 trial evaluating the efficacy and the toxicity of nivolumab alone, and of the combination nivolumab and ipilimumab - ADJORL1

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516810-39-00

Acronym

CSET N°2017/2536

Enrollment

140

Registered

2024-10-29

Start date

2018-02-13

Completion date

Unknown

Last updated

2025-04-22

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

Conditions

Adjuvant therapy after salvage surgery of high risk recurrent head and neck squamous cell carcinoma (HNSCC)

Brief summary

Two-years DFS, defined as the time from the beginning of the immunotherapy and the first locoregional or distant recurrence, or death from any cause, in cohorts 1 and 2

Detailed description

Two-years DFS in cohorts 1bis and 2 bis, Grade 3, 4, 5 toxicity, quality of life, 1-year and 2-year overall survival, DFS in subgroups determined by HPV analysis, immunoscore, PDL1 immunohistochemistry (all cohorts), PK, PD assessments

Interventions

DRUGIpilimumab

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Two-years DFS, defined as the time from the beginning of the immunotherapy and the first locoregional or distant recurrence, or death from any cause, in cohorts 1 and 2	—

Secondary

Measure	Time frame
Two-years DFS in cohorts 1bis and 2 bis, Grade 3, 4, 5 toxicity, quality of life, 1-year and 2-year overall survival, DFS in subgroups determined by HPV analysis, immunoscore, PDL1 immunohistochemistry (all cohorts), PK, PD assessments	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026