Phase III clinical trial - VADS

NIVOPOST-OP / GORTEC 2018-01
VADS
Ouvert depuis le: 09.25.2021
Site: Saint-Cloud
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A Trial Evaluating the Addition of Nivolumab to Cisplatin-RT for Treatment of Cancers of the Head and Neck (NIVOPOSTOP)
Description de l'essai

Post-operative nivolumab and concomitant chemo-radiotherapy in high-risk resected;SCCHN;Multicentric randomized phase III trial;The hypothesis is that the addition of nivolumab to post-operative cisplatin-RT will be superior to the current SOC of post-operative cisplatin-RT alone in high-risk patients with resected LA-SCCHN (exhibiting extra capsular extension (ECE) and/or positive margins. 484 Subjects will be randomized (1:1). Stratification will be based on the P16 status; Primary objective is DFS.;This open-label, randomized, controlled, multicenter phase III study will include 680 patients who have been operated for their LA SCCHN and exhibiting extra capsular extension (ECE) and/or positive margins (high risk). Subjects will be randomized (1:1) to receive post-operative concomitant cisplatin-RT with or without nivolumab.;The study is designed with the general objective of demonstrating that treatment with nivolumab in combination with 3 cycles of cisplatin during RT is more efficient and not more toxic than the SOC 3 cycles of cisplatin during RT.