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

NCT04193956 | Recruiting

• 1 other identifier: POINTING
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 2

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.

Conditions

Melanoma; Non-Small Cell Lung Cancer

Keywords

Immunotherapy; Anti-PD1 checkpoint inhibitor

Outcome Measures

Primary Outcomes (1)

• Predictive signatures based on multi-omics for PD-1 antibody treatment response as assessed by RECIST1.1

  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.

  5 years

Secondary Outcomes (1)

• 2. Predictive signatures based on multi-omics for PD-1 antibody treatment toxicity as assessed by CTCAE 4.03.

  5 years

Study Arms (1)

POINTING

Other: Standard-of-care procedures; Other: Study procedures

Interventions

Standard-of-care procedures OTHER

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.

POINTING

Study procedures OTHER

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.

POINTING

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (2)

NKI-AvL

Amsterdam, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor biopsies, venous blood samples, feces samples

MeSH Terms

Conditions

Melanoma; Carcinoma, Non-Small-Cell Lung

Interventions

Methods

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; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• E. G.E. de Vries, MD, PhD

  University Medical Center Groningen

  STUDY CHAIR

Central Study Contacts

E. G.E. de Vries, MD, PhD

CONTACT

+31 50 361 2821; e.g.e.de.vries@umcg.nl

R. S.N. Fehrmann, MD, PhD

CONTACT

+31 50 361 2821; r.s.n.fehrmann@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: December 11, 2019
• Study Start: August 1, 2018
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

NL (2)