NSCLC skin cancer (melanoma)
Conditions
Interventions
Prior to regular treatment, a CD8+ PET-LDCT scan will be performed, with a Zr89
tracer injection on D0 and a PET-LDCT on D2.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Histologically or cytological documented locally advanced or metastatic NSCLC or melanoma. 2. Patients must be eligible for standard treatment with immune checkpoint inhibitor antibody treatment (monotherapy or in combination with other anti-cancer treatments). 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
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. 3. Signs or symptoms of infection within 2 weeks prior to ZED88082A/CED88004S injection. 4. Pregnant or lactating women. 5. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins 6. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ZED88082A/CED88004S, or that may affect the interpretation of the results or render the patient at high risk from complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A multifaceted predictive signature by combining molecular omics comprising genomics, transcriptomics, proteomics withradiomics and molecular imaging, that predicts which patients have a | — |
Secondary
| Measure | Time frame |
|---|---|
| Relationship between a multifaceted signature and toxicity. | — |
Countries
Netherlands
Outcome results
None listed