A Study of Nivolumab in Patients With Head and Neck Cancer.
ProNiHN
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
1 other identifier
observational
502
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 26, 2019
CompletedFirst Submitted
Initial submission to the registry
August 2, 2019
CompletedFirst Posted
Study publicly available on registry
August 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2024
CompletedJuly 2, 2025
June 1, 2025
5 years
August 2, 2019
June 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
3 Years
Secondary Outcomes (16)
Overall Survival within Sub groups
3 year
Progression-free survival (PFS)
3 Years
Overall response rate (ORR)
3 years
Best overall response rate (BORR)
3 years
Time to response (TTR)
3 years
- +11 more secondary outcomes
Study Arms (1)
Monotherapy
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.
Interventions
Eligibility Criteria
adult patients who are at least 18 years of age with the diagnosis of Squamous Cell Carcinoma Head and Neck that the physician has already decided to initiate a treatment with nivolumab for the first time.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution - 0001
Paris, Île-de-France Region, 75005, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2019
First Posted
August 8, 2019
Study Start
June 26, 2019
Primary Completion
July 8, 2024
Study Completion
July 8, 2024
Last Updated
July 2, 2025
Record last verified: 2025-06