EU Clinical Trial 2018-002643-28

Safety and tolerability of neoadjuvant nivolumab for locally advanced resectable oral cancer, combined with [18F]BMS-986192 / [18F]-FDG PET imaging and immunomonitoring for response prediction.  Feb 25, 2019

Main objective of the trial: 1. To investigate heterogeneity in tumor uptake of [18F]BMS-986192 between patients and within tumor lesions of the same patient (primary tumor and TDLN/lymph node metastases) before treatment, in relation to changes in [18F]-FDG uptake before and on treatment 2. To investigate the feasibility and safety of neoadjuvant nivolumab immunotherapy prior to surgery for locally advanced oral cancer. 1. Onderzoeken van de heterogeniteit van opname van [18F]BMS-986192 in de tumor tussen patienten en tussen tumor laesies van dezelfde patient (primaire tumor, tumor drainerende lymfklieren en lymfkliermetastasen) vóór behandeling, in relatie tot veranderingen in [18F]-FDG opname vóór en tijdens behandeling. 2. Onderzoeken van de haalbaarheid en veiligheid van neoadjuvante nivolumab immunotherapie vóór operatieve behandeling van lokaal gevorderd mondholtecarcinoom.

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Sponsors
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EU
Keywords
BMS-936558 BMS-986192 Nivolumab Opdivo Oral cancer stage unspecified PD-L1 adnectin PET tracer

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Source:  EMA Last updated:  May 30, 2019

From ClinicalTrialsRegister.eu, a database of the European Medicines Agency. This record may not reflect the most current and accurate data available from the EMA.