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

ClinicalTrials.gov ID

NCT04193956

Lead Sponsor

University Medical Center GroningenOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

3,500Estimated

Last Update Posted

May 3, 2024Actual

Start Date

Aug 1, 2018Actual

Primary Completion Date

Sep 2024Estimated

Completion Date

Sep 2024Estimated

Official Title

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

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.

• Melanoma
• Non-Small Cell Lung Cancer

• Standard-of-care procedures
• Study procedures

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

University Medical Center GroningenOTHER

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

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