POINTING: Towards patient-tailored cancer immunotherapy supported by a multifaceted predictive signature composed of integrative omics and molecular imaging.

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 200

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A multifaceted predictive signature by combining molecular omics comprising<br /><br>genomics, transcriptomics, proteomics withradiomics and molecular imaging, that<br /><br>predicts which patients have a <= 5% chance of responding to PD-1 or anti-PD-L1<br /><br>antibody.</p><br>

Secondary Outcome Measures