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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Squamous Cell Carcinoma of the Head and Neck; Head and Neck Cancer; Head and Neck Carcinoma; Cancer of the Head and Neck
• Intervention / Treatment: Biological: Nivolumab

• Study Type: Observational
• Enrollment (Actual): 502

Contacts and Locations

Study Locations

• France
  • Paris Cedex 5, France, 75248
    • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Biological: Nivolumab; Specified dose on Specific Days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	3 Years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall response rate (ORR)	3 years
Overall Survival within Sub groups	3 year
Progression-free survival (PFS)	3 Years
Best overall response rate (BORR)	3 years
Time to response (TTR)	3 years
Duration of response (DOR)	3 years
Incidents of Adverse Events (AEs)	3 years
Incidents of immune-related Adverse Events	3 years
Incident of treatment-related Adverse Events	3 years
Number of socio-demographic characteristics in adult patients with SCCHN	3 years
Number of clinical characteristics in adult patients with SCCHN	3 Years
Number of treatment characteristics in adult patients with SCCHN	3 Years
Functional Assessment of Cancer Therapy - Head & Neck (FACT-H&N) Score	3 Years
Quality of life of caregiver (CarGoQoL ) Score	3 Years
Supportive Care Needs Survey for Partners and Caregivers (SCNS-P&C) Assessment score	3 Years
European Quality of Life-5 Dimensions (EQ-5D) score	3 Years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2019
• Primary Completion (Anticipated): September 8, 2024
• Study Completion (Anticipated): September 8, 2024

Study Registration Dates

• First Submitted: August 2, 2019
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 23, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab
• Other Study ID Numbers: CA209-9T9

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No