The goal of this investigator-initiated tumour profiling study is to analyse the relation between genomic alterations and the tumour immune contexture in patients with advanced melanoma and pancreatic cancer with resistance to (immuno)therapy, aiming to identify targets and approaches for future (combination) treatment. The main endpoint of this study is the number of patients for whom both tumour WGS and immune profiles could be adequately obtained. The co-primary endpoint is the frequency of "inflamed" vs "immune excluded/desert" tumours (based on tumour infiltrating immune cells) in patients with i) NRAS/KRAS mutant vs wild-type tumours and ii) High vs low mutational tumour load. Participants will undergo an extra tumour biopsy procedure and venepuncture once during a tumour biopsy procedure done performed as part of standard treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
180
Participants will undergo an extra tumour biopsy procedure and venepuncture once.
Amsterdam UMC, location VUmc
Amsterdam, Netherlands
Number of tumour WGS and immune profiles
number of patients for whom both tumour WGS and immune profiles could be adequately obtained
Time frame: through study completion, an average of 1 year
"inflamed" vs "immune excluded/desert" tumours
The co-primary endpoint is the frequency of "inflamed" vs "immune excluded/desert" tumours (based on tumour infiltrating immune cells) in patients with i) NRAS/KRAS mutant vs wild-type tumours and ii) High vs low mutational tumour load
Time frame: through study completion, an average of 1 year
The percentage of patients with evaluable tumour DNA, RNA and (tissue and peripheral) immune profiles
Time frame: Through study completion, an average of 2 year
The frequency of (potentially) actionable genomic alterations
Time frame: Through study completion, an average of 2 year
Differences between the post-immunotherapy and post-chemotherapy mutational/RNA-profiles with pre-treatment profiles (e.g. copy numbers, mutational load, genetic aberrations) of a similar cohort of patients who participated
Time frame: After study completion, an average of 2 year
The relation between tumour and peripheral immune profiles and changes over time in patients with intrinsic vs acquired resistance to immune checkpoint inhibition
Time frame: After study completion, an average of 2 year
The percentage of patients with melanoma with evaluable (phospho)proteomic profiles
Time frame: After study completion, an average of 2 year
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