ProNiHN: A Study of Nivolumab in Patients With Head and Neck Cancer.
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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
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Outcome Measures
Primary Outcome Measures
- Overall Survival [3 Years]
Secondary Outcome Measures
- 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]
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of Squamous Cell Carcinoma Head and Neck (SCCHN) patients progressing on or after platinum-based therapy.
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Diagnosis of SCCHN has been confirmed by histology or cytology (either at initial diagnosis or any time later during the course of the disease)
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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:
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Patients previously treated with Nivolumab, Ipilimumab, or any other antibody or drug specifically targeting T-Cell Co stimulation or immune Checkpoint pathway.
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Patients currently included in an interventional clinical trial for their SCCHN.
Other protocol defined inclusion/exclusion criteria could apply
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Local Institution | Paris Cedex 5 | France | 75248 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CA209-9T9