Cohort study of melanoma and lung cancer patients receiving immunotherapy
Towards Patient-tailored Cancer Immunotherapy Supported by a Multifaceted Predictive Signature Composed of Integrative Omics and Molecular Imaging
This study is trying to see if combining different types of tests can help predict how well immunotherapy works for people with lung cancer or melanoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Drugs / interventions | methotrexate, cyclophosphamide, prednisone, immunotherapy |
| Locations | 2 sites (Amsterdam and 1 other locations) |
| Trial ID | NCT04193956 on ClinicalTrials.gov |
What this trial studies
This is a two-center, prospective longitudinal cohort study focusing on patients with non-small cell lung carcinoma (NSCLC) or metastatic melanoma who are eligible for standard anti-PD-1 antibody treatment. The study aims to develop a predictive signature for treatment outcomes by utilizing an integrative approach that combines molecular omics, including genomics and proteomics, with radiomics and molecular imaging. Participants will undergo tumor biopsies, blood sampling, and fecal sampling to gather comprehensive data on their tumor characteristics before and during immunotherapy. This data will contribute to the POINTING project, which seeks to tailor cancer immunotherapy based on individual patient profiles.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with locally advanced or metastatic melanoma or NSCLC who are eligible for anti-PD-1 antibody treatment.
Not a fit: Patients with other malignancies within the last 5 years or those not eligible for anti-PD-1 treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective immunotherapy treatments for patients with melanoma and NSCLC.
How similar studies have performed: Other studies utilizing similar omics approaches have shown promise in predicting treatment outcomes, indicating potential success for this study.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Amsterdam and 1 other locations
- NKI-AvL — Amsterdam, Netherlands (Recruiting)
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Study coordinator: E. G.E. de Vries, MD, PhD
- Email: e.g.e.de.vries@umcg.nl
- Phone: +31 50 361 2821
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.