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Predictive Biomarkers for Response to Nivolumab in Head and Neck Squamous Cell Carcinoma

NCT03652142 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2018-08-29

No results posted yet for this study

Summary

Nivolumab is FDA-approved for the treatment of patients with recurrent/metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).

HNSCC whose disease has progressed within 6 months after platinum-based chemotherapy. The development of predictive biomarkers is needed to optimize patient benefit, minimize risk of toxicities and guide combination strategies.

Conditions

  • HNSCC
  • DNA Damage
  • DNA Double Strand Break

Interventions

OTHER

Biomarker Research

The investigators will include recurrent/metastatic HNSCC patients who progressed after cisplatin-based chemotherapy and are to be treated with nivolumab 240mg IV q 2 weeks. Patient samples will be collected with appropriate written informed consent and analyzed.

DRUG

Nivolumab

The investigators will include recurrent/metastatic HNSCC patients who progressed after cisplatin-based chemotherapy and are to be treated with nivolumab 240mg IV q 2 weeks.

Sponsors & Collaborators

  • Attikon Hospital

    lead OTHER

Principal Investigators

  • AMANDA PSYRRI, MD · ATTIKON HOSPITAL, NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS, GREECE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2020-05-01
Completion
2020-05-01
FDA Drug
Yes

Countries

  • Greece

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03652142 on ClinicalTrials.gov