Squamous Cell Carcinoma of the Head and Neck; Head and Neck Cancer; Head and Neck Carcinoma; Cancer of the Head and Neck Clinical Trial
— ProNiHNOfficial title:
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
| Verified date | March 2023 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Active, not recruiting |
| Enrollment | 502 |
| Est. completion date | September 8, 2024 |
| Est. primary completion date | September 8, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Local Institution - 0001 | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival | 3 Years | ||
| Secondary | Overall Survival within Sub groups | 3 year | ||
| Secondary | Progression-free survival (PFS) | 3 Years | ||
| Secondary | Overall response rate (ORR) | 3 years | ||
| Secondary | Best overall response rate (BORR) | 3 years | ||
| Secondary | Time to response (TTR) | 3 years | ||
| Secondary | Duration of response (DOR) | 3 years | ||
| Secondary | Incidents of Adverse Events (AEs) | 3 years | ||
| Secondary | Incidents of immune-related Adverse Events | 3 years | ||
| Secondary | Incident of treatment-related Adverse Events | 3 years | ||
| Secondary | Number of socio-demographic characteristics in adult patients with SCCHN | 3 years | ||
| Secondary | Number of clinical characteristics in adult patients with SCCHN | 3 Years | ||
| Secondary | Number of treatment characteristics in adult patients with SCCHN | 3 Years | ||
| Secondary | Functional Assessment of Cancer Therapy - Head & Neck (FACT-H&N) Score | 3 Years | ||
| Secondary | Quality of life of caregiver (CarGoQoL ) Score | 3 Years | ||
| Secondary | Supportive Care Needs Survey for Partners and Caregivers (SCNS-P&C) Assessment score | 3 Years | ||
| Secondary | European Quality of Life-5 Dimensions (EQ-5D) score | 3 Years |