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

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 - SONATA

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53449

Enrollment

180

Registered

2023-04-28

Start date

2023-07-31

Completion date

Unknown

Last updated

2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

maligne neoplasmata pancreas malignant melanoma PDAC skin cancer

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. 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 (FOLFIRINOX or gemcitabine/nab-paclitaxel). 2. Patients must be willing and able to provide written informed consent 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 biopsy can be safely obtained according to routine clinical practice.

Exclusion criteria

Exclusion criteria: Patients with metastatic or locally advanced lesions which are not considered to be technically and/or safely biopsied

Design outcomes

Primary

Measure	Time frame
The primary 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 o NRAS/KRAS mutant vs wild-type tumours o High vs low mutational tumour load	—

Secondary

Measure	Time frame
Secondary endpoints of this study are: • The percentage of patients with evaluable tumour DNA, RNA and (tissue and peripheral) immune profiles • The frequency of (potentially) actionable genomic alterations, including but not limited to HER2 amplification and mutation, HRD signature, Microsatellite instability, gene fusions • The relation between tumour and peripheral immune profiles • The percentage of patients with melanoma with evaluable (phospho)proteomic profiles • A database of all (coded) data and biobank of all (remaining) tissues and PBMCs obtained in this study.	—

Measure

Time frame

Secondary endpoints of this study are: • The percentage of patients with evaluable tumour DNA, RNA and (tissue and peripheral) immune profiles • The frequency of (potentially) actionable genomic alterations, including but not limited to HER2 amplification and mutation, HRD signature, Microsatellite instability, gene fusions • The relation between tumour and peripheral immune profiles • The percentage of patients with melanoma with evaluable (phospho)proteomic profiles • A database of all (coded) data and biobank of all (remaining) tissues and PBMCs obtained in this study.

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Countries

Netherlands

Outcome results