ZIRCONIUM (89ZR) CREFMIRLIMAB BERDOXAM for Breast cancer|Esophageal cancer|Melanoma|Non-small cell lung cancer

Inclusion criteria

• {"criterion_text":"- 1. Histologically confirmed NSCLC, melanoma, esophageal or triple negative breast cancer\n- 2. Lesion size of ≥2cm, at time of the (re)staging FDG PET/CT\n- 3. Planned to undergo resection according to routine treatment guidelines\n- 4. Neoadjuvant chemotherapy + IO is allowed\n- 5. Willing and able to provide written informed consent for the trial\n- 6. Above 18 years of age on day of signing informed consent\n- 7. Have measurable disease based on RECIST 1.15\n- 8. Have a ECOG performance status of 0-1, and are considered operable based on pulmonary function test and/or exercise testing"}

Exclusion criteria

• {"criterion_text":"- 1. Patients deemed inoperable\n- 2. Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day 0. Inhaled or topical steroids, and adrenal replacement steroid >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n- 3. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n- 4. Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial."}

Primary endpoints

• {"endpoint_text":"- The spatial overlap of the regions of uptake for both PET tracers will be assessed using the Dice Similarity Coefficient (DSC) as an established method.\n- The Pearson correlation coefficient between each tracer tumor uptake and the T cell features in regions of concordance and discordance.","definition_or_measurement_approach":"- Spatial overlap: assessed using the Dice Similarity Coefficient (DSC).\n- Correlation with T cell features: assessed using the Pearson correlation coefficient between tracer tumor uptake and T cell features in concordant/discordant regions."}

Secondary endpoints

• {"endpoint_text":"- The Pearson correlation coefficient between each tracer tumor uptake and percentage of residual viable tumor cells (VTC) in regions of concordance and discordance and the maximal VTC of the whole of the tumor.\n- The Pearson correlation coefficient between each tracer uptake and the T cell features in resected lymph nodes (if present).","definition_or_measurement_approach":"- Correlation with pathological response: Pearson correlation coefficient between tracer uptake and percentage of residual viable tumor cells (VTC), including maximal VTC for whole tumor.\n- Correlation in lymph nodes: Pearson correlation coefficient between tracer uptake and T cell features in resected lymph nodes."}

Netherlands

Earliest CTIS Part Ii Submission Date

16-05-2024

Latest Decision Or Authorization Date

30-01-2025

Processing Time Days

259

Number Of Sites

1

Number Of Participants

34

Primary sponsor

Full Name

Amsterdam UMC

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Foundation for National Institutes of Health (FNIH)","duties_or_roles":"Source of monetary support","organisation_type":""}