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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04050761
Collaborator
(none)
502
1
62.5
8

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

Study Design

Study Type:
Observational
Actual Enrollment :
502 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official 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
Actual Study Start Date :
Jun 26, 2019
Anticipated Primary Completion Date :
Sep 8, 2024
Anticipated Study Completion Date :
Sep 8, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Overall Survival [3 Years]

Secondary Outcome Measures

  1. Overall Survival within Sub groups [3 year]

  2. Progression-free survival (PFS) [3 Years]

  3. Overall response rate (ORR) [3 years]

  4. Best overall response rate (BORR) [3 years]

  5. Time to response (TTR) [3 years]

  6. Duration of response (DOR) [3 years]

  7. Incidents of Adverse Events (AEs) [3 years]

  8. Incidents of immune-related Adverse Events [3 years]

  9. Incident of treatment-related Adverse Events [3 years]

  10. Number of socio-demographic characteristics in adult patients with SCCHN [3 years]

  11. Number of clinical characteristics in adult patients with SCCHN [3 Years]

  12. Number of treatment characteristics in adult patients with SCCHN [3 Years]

  13. Functional Assessment of Cancer Therapy - Head & Neck (FACT-H&N) Score [3 Years]

  14. Quality of life of caregiver (CarGoQoL ) Score [3 Years]

  15. Supportive Care Needs Survey for Partners and Caregivers (SCNS-P&C) Assessment score [3 Years]

  16. European Quality of Life-5 Dimensions (EQ-5D) score [3 Years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT04050761
Other Study ID Numbers:
  • CA209-9T9
First Posted:
Aug 8, 2019
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 4, 2022