Squamous Cell Carcinoma Clinical Trial
Official title:
Afatinib and Nivolumab for Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) Not Previously Treated With Immunotherapy.
This phase I/Ib trial will assess the dose, safety and side effects of the combination of the cancer drugs afatinib (GILOTRIF®) and nivolumab (OPDIVO®) and to assess the anti-cancer effects of this combination of drugs when used to treat patients with advanced head and neck cancers that did not respond to previous treatments.
Primary Objectives:
Phase I: To determine dose limiting toxicities (DLTs) and maximum tolerated dose (MTD) of
afatinib when given in combination with nivolumab for subjects with recurrent/metastatic
Squamous Cell Carcinoma of the Head and Neck not previously treated with immunotherapy
Phase IB: To determine long term safety of afatinib in combination with nivolumab when
administered to subjects with recurrent/metastatic Squamous Cell Carcinoma of the Head and
Neck who had experienced disease progression during or after platinum- and cetuximab-based
chemotherapy regimen.
Secondary Objectives:
To assess progression free survival and overall survival of afatinib in combination with
nivolumab when given to subjects with recurrent/metastatic Squamous Cell Carcinoma of the
Head and Neck not previously treated with immunotherapy.
To estimate HPV stratified ORR as assessed by irRECIST in recurrent/metastatic Squamous Cell
Carcinoma of the Head and Neck not previously treated with immunotherapy.
Exploratory Objectives:
- Determination of key molecular alterations that may confer treatment resistance.
Specifically, we will examine key somatic mutations in ERBB1 (exons 18-21), ERBB2 (exon
20), and BRAF (V600) genes. We will further characterize the expression levels of ErbB2
and phosphatase and tensin homolog (PTEN) in tumor samples.
- Characterization of active CD8+ T-cell density and PD-L1 expression levels in the tumor
parenchyma pre- and on-treatment. Immunogenicity will be assessed by expression and
localization of key molecules PD-1, PD-L1, CTLA-4, TIM-3, LAG-3 and OX40 within the
tumor parenchyma.
- Characterization of circulating monocytic myeloid-derived suppressor cells (m-MDSCs)
frequency from pre-treatment peripheral blood samples.
- Characterization of HBD3 expression in the tumor parenchyma from pre-treatment tumor
tissue samples.
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