Clinical trial of nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck cancer after six months who finished platinum-based chemotherapy

Not Applicable

• Conditions: Head and Neck squamous cell carcinoma

• Registration Number: JPRN-UMIN000031324
• Lead Sponsor: Tokyo Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-19
• Study Completion: 2020-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with a past history of severe drug allergy of nivolumab and similar drug 2) Patients with a symptomatic brain metastasis and meningeal metastasis 3) Histological proven primary unknown squamous cell carcinoma, salivary gland cancer, non-squamous cell cancer. 4) Patients with a symptomatic autoimmune disease or history of Autoimmune disease. 5) Patients with infection 6) Patients with Gastrointestinal disease (Intestinal paralysis, Bowel obstruction) 7) Patients with Interstitial pneumonia or Pulmonary fibrosis 8) Uncontrolled diabetes 9) Uncontrolled heart disorder 10) Sever liver damage 11) Patients with diarrhea 12) Pregnant or lactating women or women of childbearing potential 13) Male expecting partner's pregnancy 14) Inadequate physical condition, as diagnosed by attending physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival

Secondary Outcome Measures

Name	Time	Method
1) Progression Free Survival 2) Quality of Life score