Clinical trial · Observational
A Study of Nivolumab in Patients With Head and Neck Cancer.
A French Prospective, Non-interventional Research ( NIR) of Nivolumab in Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN) Progressing on or After a Platinum-based Therapy
NCT04050761CI-TRIAL-00091669ProNiHNcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A prospective real world evidence study of Nivolumab use in France in patient with recurrent or metastatic squamous cell carcinoma of the Head and Neck progressing on or after a platinum based therapy
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma of the Head and Neck; Head and Neck Cancer; Head and Neck Carcinoma; Cancer of the Head and Neck | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Biological | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Monotherapy
- description
- Participants diagnosed with recurrent or metastatic squamous cell carcinoma of the Head and Neck and whose physician has decided to initiate a treatment with Nivolumab for the first time for the treatment of SCCHN.
- interventionNames
- Biological: Nivolumab
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 3 Years
Secondary outcomes (16)
- measure
- Overall Survival within Sub groups
- timeFrame
- 3 year
- measure
- Progression-free survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of Squamous Cell Carcinoma Head and Neck (SCCHN) patients progressing on or after platinum-based therapy. * Diagnosis of SCCHN has been confirmed by histology or cytology (either at initial diagnosis or any time later during the course of the disease) * Treatment decision to initiate a treatment with nivolumab for the first time for the treatment of SCCHN (according to the label approved in France) has already been taken Exclusion Criteria: * Patients previously treated with Nivolumab, Ipilimumab, or any other antibody or drug specifically targeting T-Cell Co stimulation or immune Checkpoint pathway. * Patients currently included in an interventional clinical trial for their SCCHN. Other protocol defined inclusion/exclusion criteria could apply
References
Publications (0)
Data not yet available
No reference posted for this study.