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

NCT03652142 | Unknown FDA Drug

• 1 other identifier: CA209-8EN
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HNSCC; DDR; DNA damage; DNA damage repair; PD-L1; PD-1; NIVOLUMAB; Head and Neck cancer

Outcome Measures

Primary Outcomes (1)

• Change in the percentage of immune cells in post treatment compared to baseline biopsies

  Primary endpoint will be the change in mean percentage of immune cells that is caused by the nivolumab treatment

  2 weeks

Secondary Outcomes (10)

• Safety of performing a biopsy after second nivolumab dose

  6 weeks

• Best overall response rate (BOR) according to RECIST 1.1 criteria

  One year

• Number of participants with tolerability to the treatment.

  From the 1st day of therapy and every week for 4 weeks maximum and 30 days after last therapy administration ]

• The burden of somatic non-synonymous mutations in association with BOR and survival

  At baseline

• The interferon-gamma gene signature in association with BOR and survival

  At baseline

Study Arms (1)

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.

Other: Biomarker Research; Drug: Nivolumab

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.

Recurrent/metastatic HNSCC

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.

Also known as: Opdivo

Recurrent/metastatic HNSCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Signed written informed consent before any trial-related procedure is undertaken
• Male or female subjects aged ≥18 years
• Availability of a formalin-fixed, paraffin-embedded tissue sample (FFPE) containing tumor

You may not qualify if:

• no inform consent provided

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

Attikon Hospital

Athens, Chaidari, Greece

RECRUITING

Related Publications (1)

• Hamid O, Schmidt H, Nissan A, Ridolfi L, Aamdal S, Hansson J, Guida M, Hyams DM, Gomez H, Bastholt L, Chasalow SD, Berman D. A prospective phase II trial exploring the association between tumor microenvironment biomarkers and clinical activity of ipilimumab in advanced melanoma. J Transl Med. 2011 Nov 28;9:204. doi: 10.1186/1479-5876-9-204.

  PMID: 22123319 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Longitudinal tissue biopsies will be collected from HNSCC patients treated with nivolumab Biopsies will be taken at baseline, 24-72 hours after the second cycle of nivolumab and at progression.

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• AMANDA PSYRRI, MD

  ATTIKON HOSPITAL, NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS, GREECE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AMANDA PSYRRI, MD

CONTACT

+302105831664; psyrri237@yahoo.com

ELENI PAPASTAMATIOU

CONTACT

+302105831256; lenagpa@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist, Associate Professor, National Kapodistrian University of Athens

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: August 29, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: August 29, 2018

Record last verified: 2018-08

Locations

GR (1)