Phase 3 clinical trial success
27 July 2017
A Phase 3 study evaluating Opdivo 3 mg/kg versus Yervoy 10 mg/kg in patients with stage IIIb/c or stage IV melanoma who are at high risk of recurrence following complete surgical resection met its primary endpoint at a planned interim analysis, demonstrating superior recurrence-free survival (RFS) in patients receiving Opdivo compared to Yervoy.
The CheckMate -238 trial, sponsored by Bristol-Myers Squibb, is important news for the oncology community; despite surgical intervention and new treatment options, many of these patients still experience disease recurrence.
The trial is an ongoing Phase 3, randomized double-blind study of Opdivo versus Yervoy in patients who have undergone complete resection of Stage IIIb/c or Stage IV melanoma. The trial randomized 906 patients to receive either Opdivo 3 mg/kg intravenously every two weeks or Yervoy 10 mg/kg IV every 3 weeks for four doses and then every 12 weeks until documented disease progression or unacceptable toxicity, up to a maximum treatment duration of one year. The primary endpoint is RFS defined as the time between randomization and the date of first recurrence or death. Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to harness the body’s own immune system to help restore anti-tumour immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
The UHBristol Haematology and Oncology Centre Clinical Trials Unit recruited 4 patients to the trial.