NCT04193956

POINTING: Clinical Cohort Study of Patients With Melanoma and NSCLC Receiving Checkpoint Inhibitors

Towards Patient-tailored Cancer Immunotherapy Supported by a Multifaceted Predictive Signature Composed of Integrative Omics and Molecular Imaging

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,500 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a two-center, prospective continuously accruing longitudinal cohort study in patients with non-small cell lung carcinoma (NSCLC) or metastatic melanoma eligible for standard anti-PD-1 antibody treatment. The data from this prospective longitudinal cohort will be used in the POINTING (towards patient -tailored cancer immunotherapy supported by a multifaceted predictive signature composed of integrative omics and molecular imaging) KWF Kankerbestrijding project (WP4). The goal of this project is to develop a multifaceted predictive signature, by using new techniques on tumor characteristics before and during treatment with immune therapy. To do so, researchers will use the 'omics' approach. By combining molecular omics comprising genomics, transcriptomics, proteomics with radiomics and molecular imaging a set of factors will arise which can accurately predict the outcome of the treatment. Participants in this cohort will undergo tumor biopsies, venous blood sampling and feces sampling before, during and at the end of standard anti-PD-1 antibody treatment. Also, data derived form routine procedures performed for standard-of-care anti-PD-1 treatment (ao laboratory assessments, CT and FDG-PET) will be collected.

Conditions

• Melanoma
• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	Standard-of-care procedures	Patients receive standard of care anti-PD-1 treatment as monotherapy or in combination with other checkpoint inhibitors. Related assessments, as laboratory assessments, CT-thorax-abdomen and FDG-PET will be performed according to clinical routine procedures.
OTHER	Study procedures	Patients will undergo tumor biopsies, venous blood sampling and feces sampling in combination with a food questionnaire before, during and at the end of standard of care anti-PD-1 treatment.

Timeline

• Start date: 2018-08-01
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2019-12-11
• Last updated: 2024-05-03

Locations

2 sites across 1 country: Netherlands