211
Participants
Start Date
May 8, 2018
Primary Completion Date
October 16, 2026
Study Completion Date
October 16, 2026
Glofitamab
Glofitamab will be administered through IV infusion every 3 weeks (Q3W) beginning Cycle 1, Day 1, for up to 17 cycles (Cycle = 21 days). Step-up dosing, in which an initial lower dose will be followed by a higher dose 1 week later, will be considered for the initial treatment phase and for Cycle 9 of the re-treatment phase.
Atezolizumab
Atezolizumab will be administered in combination with Glofitamab through IV infusion Q3W from Cycle 2, Day 1, for up to 16 cycles (Cycle = 21 days).
Obinutuzumab
Obinutuzumab will be administered once, through IV infusion, at a fixed dose 7 days before the first dose of Glofitamab.
Tocilizumab
Tocilizumab will be administered as necessary to treat cytokine release syndrome (CRS).
Polatuzumab Vedotin
Polatuzumab vedotin will be administered in combination with Glofitamab (on different days) Q3W from Cycle 1, Day 2, for up to 12 cycles (Cycle = 21 days).
89Zr-Df-IAB22M2C
Participants will receive 89Zr-Df-IAB22M2C (Cycle 1 only) prior to obinutuzumab pre-treatment and again on Day 10 after dosing with glofitamab, followed by PET/CT.
Rigshospitalet, København Ø
Odense Universitetshospital, Odense C
Aarhus Universitetshospital Skejby, Aarhus N
UZ Gent, Ghent
Fond. IRCCS Istituto Nazionale Tumori, Milan
Asst Papa Giovanni Xxiii, Bergamo
START Madrid-FJD, Hospital Fundacion Jimenez Diaz, Madrid
Hospital Clinico Universitario Virgen de la Victoria, Málaga
Policlinico S.Orsola-Malpighi, Bologna
Hospital Clinico Universitario de Valencia, Valencia
Chaim Sheba Medical Center, Ramat Gan
Istituto Nazionale Tumori Irccs Fondazione g. Pascale, Napoli
Rabin Medical Center-Beilinson Campus, Petah Tikva
Hadassah Ein Karem Hospital, Jerusalem
Hospital Universitari Vall d'Hebron, Barcelona
Hospital Duran i Reynals, Barcelona
The HOPE Clinical Trials Unit, Leicester
University College London Hospitals NHS Foundation Trust, London
The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne
Hoffmann-La Roche
INDUSTRY