HNSCC Clinical Trial
Official title:
Predictive Biomarkers For Response To Nivolumab In Head and Neck Squamous Cell Carcinoma
NCT number | NCT03652142 |
Other study ID # | CA209-8EN |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2018 |
Est. completion date | May 1, 2020 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | May 1, 2020 |
Est. primary completion date | May 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - no inform consent provided |
Country | Name | City | State |
---|---|---|---|
Greece | Attikon Hospital | Athens | Chaidari |
Lead Sponsor | Collaborator |
---|---|
Attikon Hospital |
Greece,
Hamid O, Schmidt H, Nissan A, Ridolfi L, Aamdal S, Hansson J, Guida M, Hyams DM, Gómez 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Safety of performing a biopsy after second nivolumab dose | Incidence of adverse events attributable to nivolumab treatment | 6 weeks | |
Secondary | Best overall response rate (BOR) according to RECIST 1.1 criteria | BOR will be defined as categorical variable with 3 levels { Benefit (complete response (CR), partial response (PR), stable disease (SD) lasting 6 months from the first nivolumab dose), no benefit (PD, progressive disease or SD lasting less than 6 months from the first nivolumab dose), and unknown} | One year | |
Secondary | Number of participants with tolerability to the treatment. | NCI common toxicity criteria will be used | From the 1st day of therapy and every week for 4 weeks maximum and 30 days after last therapy administration ] | |
Secondary | The burden of somatic non-synonymous mutations in association with BOR and survival | Targeted gene sequencing using next generation sequencing will be performed | At baseline | |
Secondary | The interferon-gamma gene signature in association with BOR and survival | Nanostring gene expression profiling, multiple tumor, inflammatory- and immune related genes will be analyzed by multiplex Nanostring technology by using the nCounter PanCancer Immune Profiling 770-plex gene expression Panel | At baseline | |
Secondary | The expression of PD-L1 in association with BOR and survival | PD-L1 will be assessed in tumor cells and immune cells by immunohistochemistry | At baseline and at 4 weeks | |
Secondary | The expression of human leukocyte antigens, HLA class I and HLA class II molecules in association with BOR and survival | It will be assessed at RNA and protein level | At baseline | |
Secondary | The presence of adaptive immunity cell populations | The assessment will be performed using multiplex imaging | At baseline and at 4 weeks | |
Secondary | The expression of PD-L2 in association with BOR and survival | PD-L2 will be assessed in tumor cells and immune cells by immunohistochemistry | At baseline and at 4 weeks | |
Secondary | PD-L1 expression in circulating tumor cells (CTCs) in association with BOR and survival | The assessment will be performed with Parsotrix system | At baseline and at 4 weeks |
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