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news.Merck and Endocyte have announced that the Data Safety Monitoring Board (DSMB) of the PROCEED trial has completed a pre-specified, interim futility analysis and the DSMB recommended that the trial be stopped because vintafolide did not demonstrate efficacy on the pre-specified outcome of progression-free survival (PFS) in patients with platinum-resistant ovarian cancer.
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The DSMB did not identify any safety concerns for the patients enrolled in the trial. Based on the DSMB recommendation and while further review of the data is conducted, the companies have taken steps to notify investigators that screening and randomization of participants in the trial will be suspended.
PROCEED is a Phase III randomized, double-blind clinical trial, evaluating vintafolide in combination with pegylated liposomal doxorubicin (PLD) compared to PLD plus placebo for the treatment of folate receptor-positive, platinum-resistant ovarian cancer.
The primary endpoint of the trial was PFS as measured by RECIST v 1.1 (response evaluation criteria in solid tumor) criteria in patients with all target tumor lesions positive as assessed by etarfolatide imaging agent.