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Active, not recruiting

NCT Number: NCT07796594

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

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Melanoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pancreas Cancer Pancreatic Diseases Pancreatic Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC, location VUmc

Amsterdam, 1081HZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

a. 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.

b. 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.

Exclusion criteria

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

Treatment and study plan

Biopsy

Procedure

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

Primary outcomes

  1. 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

  2. "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

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

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Official study 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

Acronym: SONATA

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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