NELARABINE for Melanoma|Breast cancer|Non-small cell lung cancer|Esophageal cancer

Inclusion criteria

• {"criterion_text":"- Histologically confirmed NSCLC, melanoma, esophageal, or breast cancer\n- Ongoing immunotherapy using an anti-PD-(L)1 agent\n- Planned to be treated with high dose (24Gy) radiotherapy per clinical indication\n- Be willing and able to provide written informed consent for the trial.\n- Have a performance status of 0-2 on the ECOG Performance Scale\n- Be above 18 years of age on day of signing informed consent."}

Exclusion criteria

• {"criterion_text":"- Subjects 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- Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n- Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial, starting with the screening visit through 12 weeks after the last administration of [ 18F]F-AraG."}

Primary endpoints

• {"endpoint_text":"- To assess the relative change in uptake of [18F]F-AraG in tumor lesions on anti-PD-1 treatment. i. To define tracer uptake in all tumor lesions and lymphoid organs (lymph nodes, spleen) per [ 18F]F-AraG PET scan using the optimized simplified uptake parameter (SUV, TBR, TPR). ii. To assess the changes in uptake between baseline and after 1 and 3 weeks post-RT, respectively.","definition_or_measurement_approach":"Tracer uptake defined per [18F]F-AraG PET scan using optimized simplified uptake parameters (SUV, TBR, TPR); changes assessed between baseline and after 1 and 3 weeks post-radiotherapy."}

Netherlands

Earliest CTIS Part Ii Submission Date

23-09-2024

Latest Decision Or Authorization Date

02-10-2024

Processing Time Days

9

Number Of Sites

1

Number Of Participants

12

Primary sponsor

Full Name

Amsterdam UMC Stichting

Organisation Type

Patient organisation/association

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Boehringer Ingelheim","duties_or_roles":"Source of monetary support","organisation_type":""}