POINTING: Clinical Cohort Study of Patients With Melanoma and NSCLC Receiving Checkpoint Inhibitors (POINTING)
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|ClinicalTrials.gov Identifier: NCT04193956|
Recruitment Status : Recruiting
First Posted : December 11, 2019
Last Update Posted : December 11, 2019
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.
|Condition or disease||Intervention/treatment|
|Melanoma Non-Small Cell Lung Cancer||Other: Standard-of-care procedures Other: Study procedures|
|Study Type :||Observational|
|Estimated Enrollment :||3500 participants|
|Official Title:||Towards Patient-tailored Cancer Immunotherapy Supported by a Multifaceted Predictive Signature Composed of Integrative Omics and Molecular Imaging|
|Actual Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2023|
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.
- Predictive signatures based on multi-omics for PD-1 antibody treatment response as assessed by RECIST1.1 [ Time Frame: 5 years ]The aim of this clinical cohort is to develop and validate multifaceted predictive signatures for PD-1 antibody effects with relevant components of integrative omics (histology, immunohistochemistry, genomics, transcriptomics, proteomics, radiomics and/or molecular imaging), which predict, which patients have a ≤ 5% chance of responding to anti-PD-1 antibody treatment.
- 2. Predictive signatures based on multi-omics for PD-1 antibody treatment toxicity as assessed by CTCAE 4.03. [ Time Frame: 5 years ]As secondary aim, the relation between multifaceted signatures composed by relevant components of integrative omics (histology, immunohistochemistry, genomics, transcriptomics, proteomics, radiomics and/or molecular imaging) and toxicity of PD-1 antibody treatment will be assessed. Toxicity will be scored according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04193956
|Contact: E. G.E. de Vries, MD, PhD||+31 50 361 firstname.lastname@example.org|
|Contact: R. S.N. Fehrmann, MD, PhD||+31 50 361 email@example.com|
|Contact: J. B.A.G. Haanen, MD, PhD +31 20 512 9111 firstname.lastname@example.org|
|Principal Investigator: J. B.A.G. Haanen, MD, PhD|
|University Medical Center Groningen||Recruiting|
|Contact: E. G.E. de Vries, MD, PhD +31 50 361 2821 email@example.com|
|Contact: R. S.N. Fehrmann, MD, PhD +31 50 361 2821 firstname.lastname@example.org|
|Principal Investigator: E. G.E. de Vries, MD, PhD|
|Study Chair:||E. G.E. de Vries, MD, PhD||University Medical Center Groningen|