Actively Recruiting
POINTING: Clinical Cohort Study of Patients With Melanoma and NSCLC Receiving Checkpoint Inhibitors
Led by University Medical Center Groningen · Updated on 2024-05-03
3500
Participants Needed
2
Research Sites
317 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
POINTING: Clinical Cohort Study of Patients With Melanoma and NSCLC Receiving Checkpoint Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced or metastatic melanoma or NSCLC
- Eligible for standard anti-PD-1 antibody treatment (monotherapy or combined with other checkpoint inhibitors)
- Age 18 years or older
- Measurable disease as defined by RECIST v1.1, excluding previously irradiated lesions as target lesions
- Metastatic or locally advanced lesions that can be safely biopsied according to clinical care standards
- Ability to comply with the study protocol
- Signed informed consent form
You will not qualify if you...
- Other malignancies within 5 years before study entry, except those with very low risk of metastasis or death treated curatively (e.g., carcinoma in situ of cervix, basal or squamous cell skin cancer, localized prostate cancer treated curatively, ductal carcinoma in situ treated surgically)
- Use of systemic immunosuppressive drugs (such as prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-tumor necrosis factor agents) within 2 weeks before study start
- Patients on acute, low-dose systemic immunosuppressants may participate
- Use of inhaled corticosteroids for COPD, mineralocorticoids for orthostatic hypotension, or low-dose corticosteroids for adrenal insufficiency is allowed
AI-Screening
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Trial Site Locations
Total: 2 locations
1
NKI-AvL
Amsterdam, Netherlands
Actively Recruiting
2
University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
Research Team
E
E. G.E. de Vries, MD, PhD
CONTACT
R
R. S.N. Fehrmann, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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