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

NCT07796594 | Active Not Recruiting

• 1 other identifier: AUMC-MEDONC-SONATA-2022
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Number of tumour WGS and immune profiles

  number of patients for whom both tumour WGS and immune profiles could be adequately obtained

  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

  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

  Through study completion, an average of 2 year

• The frequency of (potentially) actionable genomic alterations

  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

  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

  After study completion, an average of 2 year

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

  After study completion, an average of 2 year

Study Arms (1)

Single arm tumour profiling study

OTHER

Patients undergo tumour biopsy and blood draw once

Procedure: Biopsy

Interventions

Biopsy PROCEDURE

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

Single arm tumour profiling study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

Amsterdam UMC, location VUmc

Amsterdam, 1081HZ, Netherlands

Location

MeSH Terms

Conditions

Melanoma; Pancreatic Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 1, 2026
• Study Start: July 13, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 1, 2026

Record last verified: 2026-08

Locations

NL (1)