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

Sponsor
Attikon Hospital
Study ID
NCT03652142
Status
Unknown

Conditions

  • DNA Damage
  • DNA Double Strand Break
  • HNSCC

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biomarker Research — OTHER
    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.
  • Nivolumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 1, 2018
Status verified
Aug 2018
Primary completion
May 1, 2020
Completion
May 1, 2020

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Recurrent/metastatic HNSCC
    The investigators will include recurrent/metastatic HNSCC patients who progressed after cisplatin-based chemotherapy and are to be treated with nivolumab. Tumor biopsies will be performed at baseline, after the second cycle and at progression with appropriate written informed consent and the samples will be analyzed. Biomarker research will be performed. The patients will receive intravenously nivolumab at dose of 240 mg every 2 weeks (240mg q2w). The patients will undergo tumor biopsy at baseline and within 24-72h after the second administration of treatment, and at progression of their disease.

Primary Outcome Measure

Change in the percentage of immune cells in post treatment compared to baseline biopsies [ Time Frame: 2 weeks ]

Central Contacts

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