ClinicalTrials.gg
Active, not recruitingNCT07796594SONATAUpdated Sep 1, 2026

Integration of Whole-Genome Sequencing PrOfiles and ImmuNe StATus in Cancer

An interventional study of Biopsy in Melanoma and Pancreas Cancer, sponsored by Amsterdam UMC, location VUmc. Active, not recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Amsterdam UMC, location VUmc · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 170 studies in Melanoma with a site in Netherlands — 29 open to participants now, 49 under way, 13 of them phase 3. Melanoma · Netherlands.

Planned enrollment
78th of 157
180 · median 180
Started
2023
with 10 others
No phase
17 of 170
7 open now
Primary completion
2026-12
later than 24 of 48 live
Registered
150th of 170
by date

Among the 170 studies in Melanoma with a site in Netherlands, this one is the 78th largest by planned enrollment of the 157 interventional ones that give a count, is one of 11 that started in 2023, is one of 17 with no phase, reaches primary completion later than 24 of the 48 other live ones, and was the 150th registered.

Melanoma

3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.

Browse Melanoma studies →

Open to participants now

29 of the 170 studies in Melanoma with a site in Netherlands are open now. Recruiting first, the newest first:

24 more — sign in →

All 29 open studies →

A study can be open while its sites in Netherlands have not opened yet or have stopped. Only those recruiting at a site in Netherlands →

Who these studies take

Of the 467 Melanoma studies recruiting now, 380 (81%) set no upper age limit and 49 (10%) stop at 75 or younger; 47 take children under 18; 29 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 170 studies in Melanoma with a site in Netherlands, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Melanoma
  • Pancreas Cancer
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Diagnosis of locally advanced or cutaneous/mucosal melanoma or pancreatic cancer, meeting the following characteristics:

    a. Melanoma i. Patients with 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) 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 chemotherapy with FOLFIRINOX.

  2. Patients must be willing and able to provide written 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 can be safely obtained according to routine clinical practice.

Exclusion criteria

Exclusion Criteria:

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

Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Other
    Single arm tumour profiling study

    Patients undergo tumour biopsy and blood draw once

    Procedure: Biopsy

Interventions

  • ProcedureBiopsy

    Participants will undergo an extra tumour biopsy procedure and venepuncture once.

06

What researchers measure

Primary outcomes

  1. 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

  2. "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

Secondary outcomes

  1. 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

  2. The frequency of (potentially) actionable genomic alterations

    Time frame: Through study completion, an average of 2 year

  3. 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

  4. 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

  5. The percentage of patients with melanoma with evaluable (phospho)proteomic profiles

    Time frame: After study completion, an average of 2 year

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2023 (actual). Primary completion is estimated for Dec 2026, 41 months after the start.

Of 219 non-industry interventional studies with no phase under Melanoma, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 62. This study's planned 41 months is close to that.

Counting every sponsor, half of 227 studies reached it within 38 months; a quarter within 20 and three quarters within 62.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2023
First posted
Sep 1, 2026
StartActual
Jul 13, 2023
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07796594
Responsible party
Mariette Labots (Principal Investigator, Amsterdam UMC, location VUmc) — Principal investigator
First posted
Sep 1, 2026
Start date
Jul 13, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 1, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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