A Study of Nivolumab in Patients With Head and Neck Cancer.

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
• Interventions: Biological: Nivolumab

• Registration Number: NCT04050761
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-06-26
• Study First Submitted: 2019-08-02
• Study First Submitted QC: 2019-08-07
• Study First Posted: 2019-08-08
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-08
• Primary Completion: 2024-09-08
• Study Completion: 2024-09-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 502

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Monotherapy	Nivolumab	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.

Primary Outcome Measures

Name	Time	Method
Overall Survival	3 Years

Secondary Outcome Measures

Name	Time	Method
Overall Survival within Sub groups	3 year
Progression-free survival (PFS)	3 Years
Functional Assessment of Cancer Therapy - Head & Neck (FACT-H&N) Score	3 Years
Best overall response rate (BORR)	3 years
Overall response rate (ORR)	3 years
Duration of response (DOR)	3 years
Incidents of immune-related Adverse Events	3 years
Number of treatment characteristics in adult patients with SCCHN	3 Years
Time to response (TTR)	3 years
Incidents of Adverse Events (AEs)	3 years
Number of clinical characteristics in adult patients with SCCHN	3 Years
Number of socio-demographic characteristics in adult patients with SCCHN	3 years
Quality of life of caregiver (CarGoQoL ) Score	3 Years
Incident of treatment-related Adverse Events	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

Trial Locations

Locations (1)

Local Institution - 0001; 🇫🇷 Paris, France