MelanomaSONATANCT07796594
Integration of Whole-Genome Sequencing PrOfiles and ImmuNe StATus in Cancer
A study testing Biopsy in people with Melanoma and Pancreas Cancer, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Pancreas Cancer
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Jul 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with metastatic or locally advanced lesions which are not considered to be technically and/or safely biopsied.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- Biopsy
- Medical subject headings
- Melanoma, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Participants will undergo an extra tumour biopsy procedure and venepuncture once.
| Study group | Role | What they receive |
|---|---|---|
| Single arm tumour profiling study | Other | Patients undergo tumour biopsy and blood draw once Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of tumour WGS and immune profiles
number of patients for whom both tumour WGS and immune profiles could be adequately obtained
Measured: 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
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
The percentage of patients with evaluable tumour DNA, RNA and (tissue and peripheral) immune profiles
Measured: Through study completion, an average of 2 year
The frequency of (potentially) actionable genomic alterations
Measured: 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
Measured: 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
Measured: After study completion, an average of 2 year
The percentage of patients with melanoma with evaluable (phospho)proteomic profiles
Measured: After study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start13 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariette Labots, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796594
- Sponsor's protocol ID
- AUMC-MEDONC-SONATA-2022
- Acronym
- SONATA
- Status last verified
- Aug 2026
- First submitted
- 14 Sep 2023
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07796594
- Acronym / sponsor ID
- SONATA / AUMC-MEDONC-SONATA-2022
- Conditions
- Melanoma, Pancreas Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm tumour profiling study | Other | Procedure: BiopsyPatients undergo tumour biopsy and blood draw once |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of locally advanced or metastatic cutaneous/mucosal melanoma or pancreatic cancer, meeting the following characteristics:
- 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.
Key exclusion criteria (1 listed)
- Patients with metastatic or locally advanced lesions which are not considered to be technically and/or safely biopsied.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyParticipants will undergo an extra tumour biopsy procedure and venepuncture once. | Procedure or surgery | Single arm tumour profiling study |
Primary outcome
Number of tumour WGS and immune profiles
Time frame: through study completion, an average of 1 year
number of patients for whom both tumour WGS and immune profiles could be adequately obtained
"inflamed" vs "immune excluded/desert" tumours
Time frame: through study completion, an average of 1 year
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy in people with Melanoma and Pancreas Cancer, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of tumour WGS and immune profiles (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.