Clinical trial NCT04490564: Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood and Primary Tumor in HNSCC/NSCLC/Melanoma
Official title: A Clinical Performance Study to Validate the Use of Novel Molecular Diagnostic Assays for the Detection of Cancer Biomarkers in Peripheral Blood and Primary Tumor Tissue of Patients With Recurrent/Metastatic HNSCC, NSCLC or Melanoma.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Squamous Cell Carcinoma
Non Small Cell Lung Cancer
Melanoma
Keywords: Liquid biopsy
CTC
PD-L1
Lead sponsor: Pharmassist Ltd
Sponsor class: INDUSTRY
Collaborators: name: University of Athens
First posted: 2020-07-29
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 155 subjects as follows: 25 patients with metastatic/recurrent HNSCC 120 patients with metastatic NSCLC 10 patients with metastatic melanoma 30 healthy subjects

Brief summary: Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment.

Liquid biopsy is a non-invasive approach based on the extraction of information through peripheral blood analysis. It makes it possible to characterize the development of a solid tumor in real time, through detailed molecular analysis of circulating genetic material in peripheral blood.

Detailed description: Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment.

Liquid biopsy is a non-invasive approach based on the extraction of information through peripheral blood analysis. It makes it possible to characterize the development of a solid tumor in real time, through detailed molecular analysis of circulating genetic material in peripheral blood.

Study procedure:

1. Initial Visit (V0-Baseline): For the purposes of the study the following information will be collected: the demographics, medical and social history, the characteristics of the disease (stage, molecular characterization e.t.c) and the treatment regimen that is followed. As part of the visit, 20 mL of peripheral blood will be drawn prior to their treatment according to physician's suggestion as per common clinical practice. Blood samples will be then sent to ACTC laboratory for plasma/CTC isolation, DNA and RNA extraction and subsequent test for biomarkers. Primary tumor tissue samples will be also collected.
2. Follow-up visit (V1): All patients will provide a 10 mL peripheral blood sample during their planned visit at the end of a series of immunotherapy cycles as per clinical practice and physician's judgment. More specifically:

   For HNSCC/NSCLC: at the end of four (4) treatment cycles with nivolumab (2 months) or at the end of three (3) treatment cycles with pembrolizumab (2 months) or on disease progress (PD) For melanoma: at 6 months after treatment initiation (antiPD-1) Blood samples will be then sent to laboratory for plasma/CTC isolation, DNA and RNA extraction and subsequent test for biomarkers. Clinical response (CR, PR, SD, PD) will be also documented.
3. Follow-up visit (V2): All patients will provide a 10 mL peripheral blood sample on progress of the disease or at the end of the observation period, as diagnosed during their planned visit as per clinical practice and physician's judgment. Blood samples will be then sent to laboratory

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical performance of PD-L1 kit in CTCs of peripheral blood and tumor tissue samples
timeFrame: 12 months
Secondary outcomes:
measure: To study correlations between PD-L1 expression in serial liquid samples with patients' responsiveness to therapy.
timeFrame: 18 months
Other outcomes:
measure: To study mutation status of BRAF gene in tumor tissue samples and blood samples (CTC, plasma ctDNA) of metastatic melanoma patients
timeFrame: 18 months
measure: To study the presence of biomarkers in tumor tissue and blood liquid biopsy samples (at baseline).
timeFrame: 18 months
Locations:
city: Athens
country: Greece
facility: Sotiria Thoracic Diseases Hospital of Athens
state: Attica
city: Athens
country: Greece
facility: Aretaieio University Hospital of Athens
state: Attica
city: Athens
country: Greece
facility: University General Hospital of Athens Attikon
state: Attika
city: Thessaloníki
country: Greece
facility: Bioclinic
state: Thessaloniki
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupoli
city: Piraeus
country: Greece
facility: Metropolital Hospital
Study officials:
References: