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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04193956
Recruitment Status : Recruiting
First Posted : December 11, 2019
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
Prof.dr. E.G.E. de Vries, University Medical Center Groningen

Brief 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.


Condition or disease Intervention/treatment
Melanoma Non-Small Cell Lung Cancer Other: Standard-of-care procedures Other: Study procedures

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Study Type : Observational
Estimated Enrollment : 3500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Group/Cohort Intervention/treatment
POINTING 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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
Tumor biopsies, venous blood samples, feces samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with locally advanced or metastatic melanoma or metastatic NSCLC, who are eligible to receive anti-PD-1 antibody treatment as monotherapy or in combination with other checkpoint inhibitors.
Criteria

Inclusion criteria:

  1. Histologically or cytological documented locally advanced or metastatic melanoma or NSCLC.
  2. Patients must be eligible for standard treatment with anti-PD-1 antibody treatment (monotherapy or in combination with other checkpoint inhibitors).
  3. Age ≥18 years.
  4. Measurable disease, as defined by standard RECIST v1.1. Previously irradiated lesions should not be counted as target lesions.
  5. Metastatic or locally advanced lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
  6. Ability to comply with protocol.
  7. Signed Informed Consent form.

Exclusion Criteria:

  1. Malignancies other than melanoma or NSCLC within 5 years prior to inclusion, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent or ductal carcinoma in situ treated surgically with curative intent).
  2. Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to study inclusion.

    • Patients who have received acute, low-dose, systemic immunosuppressant medications may be enrolled.
    • The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g. fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.

Information from the National Library of Medicine

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


Contacts
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Contact: E. G.E. de Vries, MD, PhD +31 50 361 2821 e.g.e.de.vries@umcg.nl
Contact: R. S.N. Fehrmann, MD, PhD +31 50 361 2821 r.s.n.fehrmann@umcg.nl

Locations
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Netherlands
NKI-AvL Recruiting
Amsterdam, Netherlands
Contact: J. B.A.G. Haanen, MD, PhD    +31 20 512 9111    j.haanen@nki.nl   
Principal Investigator: J. B.A.G. Haanen, MD, PhD         
University Medical Center Groningen Recruiting
Groningen, Netherlands
Contact: E. G.E. de Vries, MD, PhD    +31 50 361 2821    e.g.e.de.vries@umcg.nl   
Contact: R. S.N. Fehrmann, MD, PhD    +31 50 361 2821    r.s.n.fehrmann@umcg.nl   
Principal Investigator: E. G.E. de Vries, MD, PhD         
Sponsors and Collaborators
Prof.dr. E.G.E. de Vries
Investigators
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Study Chair: E. G.E. de Vries, MD, PhD University Medical Center Groningen

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Responsible Party: Prof.dr. E.G.E. de Vries, Principal investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT04193956    
Other Study ID Numbers: POINTING
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Prof.dr. E.G.E. de Vries, University Medical Center Groningen:
Immunotherapy
Anti-PD1 checkpoint inhibitor
Additional relevant MeSH terms:
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Melanoma
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas