Announcement: NIMBUS trial to end in 2020
The EAU Research Foundation’s Randomised Phase III Clinical Trial NIMBUS has stopped recruitment due to the results of a safety analysis.
The trial, which ran from 2013 and studied reduced frequency BCG instillations in NMIBC, involved nearly 360 patients in seven countries.
The NIMBUS study assessed whether a reduced number of BCG instillations was not inferior to standard number and dose intravesical BCG treatment in patients with high grade non-muscle invasive bladder cancer (NMIBC). Primary endpoint was time to first recurrence. The target was to enroll 824 patients with high grade Ta-T1 urothelial carcinoma of the bladder with or without CIS and who did not receive any previous BCG intravesical instillation therapy.
Safety analyses by the Independent Data Monitoring Committee (IDMC) showed reduced frequency schedule of BCG to be inferior to standard frequency schedule for the primary endpoint according to the previously defined stop criterion. Recruitment was immediately stopped and all participating sites were instructed to inform patients and offer patients in the reduced frequency treatment arm the possibility to switch to the standard frequency. The follow-up period, which was initially 3 years, will be shortened until all patients have at least 6 months of follow-up. At the time of stopping recruitment, a total of 359 patients were randomised (see recruitment graph below).
The EAU Research Foundation wishes to thank the patients who participated in NIMBUS and the many centres in Europe for their dedicated and hard work to enroll patients in this study.
Despite the premature ending of the trial, the data collected in this trial will enable to answer some important scientific questions concerning the use of BCG intravesical therapy in the management of High Grade Ta/T1 bladder tumours. Also, biospecimens were collected for (a) the identification and validation of association signals in relation to BCG recurrence and progression using genome-wide DNA analyses (DNA substudy) and (b) mechanistic insights on the relevance of specific immune response processes and evaluation immune-related BCG response biomarkers (Cytokine substudy).
Recruitment graph of all randomised patients:
NIMBUS Research team
Protocol Committee:
- Marko Babjuk, Prague
- Luis Martinez-Pineiro, Madrid
- Joan Palou Redorta, Barcelona
- Anup Patel, London
- Levent Türkeri, Istanbul
- Marc-Oliver Grimm, Jena
- Wim P.J. Witjes, Arnhem
National Coordinators:
- Germany: Marc-Oliver Grimm
- The Netherlands: Toine Van Der Heijden
- France: Marc Colombel
- Spain: Luis Martinez-Piñeiro
- Belgium: Tim Muilwijk
- Italy: Andrea Gallina
- Turkey: Levent Türkeri
EAU Research Foundation:
- Anders Bjartell, Chairman
- Wim Witjes, Scientific and Clinical Research Director
- Raymond Schipper Clinical Project Manager
- Christien Caris, Clinical Project manager
- Ilse Christ, Clinical Research Associate
- Joke van Egmond, Clinical Data manager
- Xandra Helmonds, Financial Officer
- Hans Noordzij, Marvin Management Assistant
NIMBUS Principal Coordinators:
- Levent Türkeri Marmara University Medical School Istanbul, Turkey
- Marko M. Babjuk Charles University 2nd Faculty of Medicine Prague, Czech Republic
EAU RF Central Research Office
PO Box 30016, 6803 AA Arnhem, The Netherlands
Email: researchfoundation@uroweb.org
Phone: +31 (0) 26 38 90 677