Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood and Primary Tumor in HNSCC/NSCLC/Melanoma

Plain-language summary

This study validated molecular diagnostic assays (including a PD-L1 Kit) that detect cancer biomarkers in blood and tumor tissue in patients with head and neck squamous cell carcinoma, non-small cell lung cancer and melanoma. Patients aged 18 and over who were going to receive PD-1 inhibitor therapy were eligible. It was a non-phase study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Pharmassist Ltd

Intervention

PD-L1 Kit

Start date

6/25/2019

Estimated completion

9/7/2022

Countries

Greece

Related genes

Locations

• Alexandroupoli, Greece
• Athens, Greece
• Athens, Greece
• Athens, Greece
• Piraeus, Greece
• Thessaloniki, Greece

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Male or female aged ≥ 18 years of age.
2. Patients with a diagnosis of

   1. recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), who are going to receive PD-1 inhibitor nivolumab OR
   2. metastatic Non-Small Cell Lung Cancer (NSCLC), who are going to receive PD-1 inhibitor, e.g. nivolumab, pembrolizumab,OR
   3. metastatic melanoma, who are going to receive to receive PD-1 inhibitor, e.g. nivolumab, pembrolizumab.
3. Available tumor tissue sample for immunohistochemical and molecular analysis.
4. Life expectancy ≥ 4 months.
5. Signed informed consent form.

Exclusion Criteria:

1. Male or female younger than 18 years old.
2. History of another malignancy within 3 years or current 2nd primary malignancy.
3. Patients that have not signed the informed consent.