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About this trial

The purpose of this trial is to compare whether there is a difference in treatment outcome for patients treated with Nivolumab manufactured by Process C or the newly developed comparable drug manufactured by Process D.

Nivolumab is currently being developed in the treatment of Melanoma and has been shown to derive benefit in patients with completely resected Stage IIIb/c or Stage IV. This study will compare both processes of developing the drug. Patients will be treated by IV every 2 weeks from Week 1 to Week 17 followed by every 4 weeks from week 19 to Week 51.

Patient Profile

Where’s this trial being run?

Cork University Hospital

Can I join this study / trial?

The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.

Why not Print this page and bring it with you. It will help your doctor and research team advise you.

For more detailed information

Questions?

Here’s a list of questions you may have for your doctor or local cancer research team.

Summary Data

Name: CA209-8FC
Number: 19-13
Full Title:

Randomized, Double-Blind, Parallel, Phase 1 Study to Compare the Pharmacokinetics of BMSCHO1-Nivolumab Process D to Nivolumab Process C after Complete Resection of Stage IIIa/b/c/d or Stage IV Melanoma

Principal Investigator: Dr. Derek Power (Cork University Hospital)
Type: Industry Sponsored
Sponsor:

Bristol Myers Squibb (BMS)

Recruitment Started: Global: 24th June 2019
Ireland: 8th November 2019
Global Recruitment Target: 254
Ireland Recruitment Target: 10