NCT07796594Active, not recruiting
Integration of Whole-Genome Sequencing PrOfiles and ImmuNe StATus in Cancer
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
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 14 Sept 2023
- Start date
- 13 Jul 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Amsterdam UMC, location VUmc
- Diseases
- Melanoma, Pancreatic cancer
- NCT number
- NCT07796594
What you commit to
- Study type: Interventional
- Planned participants: 180
- From 13 Jul 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- \- Patients with metastatic or locally advanced lesions which are not considered to be technically and/or safely biopsied.
Who the study is looking for
- Diagnosis of locally advanced or metastatic cutaneous/mucosal melanoma or pancreatic cancer, meeting the following characteristics:
- 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.
- Pancreatic cancer i. Patients with histologically proven metastatic pancreatic cancer with progression under or after standard first-line chemotherapy with FOLFIRINOX.
- Patients must be willing and able to provide written informed consent and be willing and able to comply with the study protocol.
- Patients must be ≥18 years of age.
- Metastatic or locoregional lesion of which a tumour needle biopsy can be safely obtained according to routine clinical practice.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC location VUmc Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.