Integration of Whole-Genome Sequencing profiles and Immune Status in cancer - a molecular profiling protocol to broaden the view on drug targets and immune contexture in patients with melanoma and pancreatic cancer

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 180

Inclusion Criteria

1. Diagnosis of locally advanced or metastatic cutaneous/mucosal melanoma or
pancreatic cancer, meeting the following characteristics:
a. Melanoma
i. Patients with histologically proven locally advanced or metastatic melanoma
(stage IV), with intrinsic or acquired resistance to treatment with immune
checkpoint inhibition (anti-PD1 antibody +/- ipilimumab)
ii. Patients with locoregional or distant recurrence either during, or within 3
months after completion or discontinuation of (neo)adjuvant anti-PD1-based
immunotherapy for stage III melanoma.
b. Pancreatic cancer
i. Patients with histologically proven metastatic pancreatic cancer with
progression under or after standard first-line chemotherapy (FOLFIRINOX or
gemcitabine/nab-paclitaxel).
2. Patients must be willing and able to provide written informed consent and be
willing and able to comply with the study protocol.
3. Patients must be >=18 years of age.
4. Metastatic or locoregional lesion of which a tumour needle biopsy can be
safely obtained according to routine clinical practice.

Exclusion Criteria

Patients with metastatic or locally advanced lesions which are not considered
to be technically and/or safely biopsied

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study is the number of patients for whom both<br /><br>tumour WGS and immune profiles could be adequately obtained.<br /><br>The co-primary endpoint is the frequency of inflamed vs immune<br /><br>excluded/desert tumours (based on tumour infiltrating immune cells) in<br /><br>patients with<br /><br>o NRAS/KRAS mutant vs wild-type tumours<br /><br>o High vs low mutational tumour load </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints of this study are:<br /><br>• The percentage of patients with evaluable tumour DNA, RNA and (tissue and<br /><br>peripheral) immune profiles<br /><br>• The frequency of (potentially) actionable genomic alterations, including but<br /><br>not limited to HER2 amplification and mutation, HRD signature, Microsatellite<br /><br>instability, gene fusions<br /><br>• The relation between tumour and peripheral immune profiles<br /><br>• The percentage of patients with melanoma with evaluable (phospho)proteomic<br /><br>profiles<br /><br>• A database of all (coded) data and biobank of all (remaining) tissues and<br /><br>PBMCs obtained in this study.</p><br>