Integration of Whole-Genome Sequencing PrOfiles and ImmuNe StATus in Cancer
NCT07796594 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180
Last updated 2026-09-01
Summary
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.
Conditions
- Melanoma
- Pancreas Cancer
Interventions
- PROCEDURE
-
Biopsy
Participants will undergo an extra tumour biopsy procedure and venepuncture once.
Sponsors & Collaborators
-
Amsterdam UMC, location VUmc
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-13
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- Netherlands
Study Locations
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