![nivolumab clone 5-h1 nivolumab clone 5-h1](https://resources.rndsystems.com/images/datasheets/antibody/B7H1_FAB1561P_Flow_Cytometry_16224.jpg)
Median progression-free survival was 3♰ months (95% CI 2♸–4♱) in the nivolumab group versus 1♸ months (1♴–2♶) in the placebo group (adjusted hazard ratio 0♶7 p=0♰090). Median follow-up was 11♶ months (IQR 7♲–16♸).
Nivolumab clone 5 h1 trial#
This trial is registered with, NCT03063450.īetween May 10, 2017, and March 30, 2020, 332 patients were recruited, of whom 221 (67%) were randomly assigned to the nivolumab group and 111 (33%) were assigned to the placebo group). All patients who were randomly assigned were included in the safety population, reported according to group allocation. The co-primary endpoints were investigator-assessed progression-free survival and overall survival, analysed according to the treatment policy estimand (an equivalent of the intention-to-treat principle). Participants and treating clinicians were masked to group allocation. The randomisation sequence was generated within an interactive web response system (Alea) patients were stratified according to epithelioid versus non-epithelioid histology and were assigned in random block sizes of 3 and 6. Adult patients (aged ≥18 years) with an Eastern Cooperative Oncology Group performance status of 0 or 1, with histologically confirmed pleural or peritoneal mesothelioma, who had received previous first-line platinum-based chemotherapy and had radiological evidence of disease progression, were randomly assigned (2:1) to receive nivolumab at a flat dose of 240 mg every 2 weeks over 30 min intravenously or placebo until disease progression or a maximum of 12 months. This was a multicentre, placebo-controlled, double-blind, parallel group, randomised, phase 3 trial done in 24 hospitals in the UK.