Clinical trial NCT04193956: POINTING: Clinical Cohort Study of Patients With Melanoma and NSCLC Receiving Checkpoint Inhibitors
Official title: Towards Patient-tailored Cancer Immunotherapy Supported by a Multifaceted Predictive Signature Composed of Integrative Omics and Molecular Imaging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanoma
Non-Small Cell Lung Cancer
Keywords: Immunotherapy
Anti-PD1 checkpoint inhibitor
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Predictive signatures based on multi-omics for PD-1 antibody treatment response as assessed by RECIST1.1
timeFrame: 5 years
Secondary outcomes:
measure: 2. Predictive signatures based on multi-omics for PD-1 antibody treatment toxicity as assessed by CTCAE 4.03.
timeFrame: 5 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: NKI-AvL
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: E. G.E. de Vries, MD, PhD
role: STUDY_CHAIR
References: