An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

211

Participants

Timeline

Start Date

May 8, 2018

Primary Completion Date

October 16, 2026

Study Completion Date

October 16, 2026

Conditions
Non-Hodgkins Lymphoma
Interventions
DRUG

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.

DRUG

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).

DRUG

Obinutuzumab

Obinutuzumab will be administered once, through IV infusion, at a fixed dose 7 days before the first dose of Glofitamab.

DRUG

Tocilizumab

Tocilizumab will be administered as necessary to treat cytokine release syndrome (CRS).

DRUG

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).

DRUG

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.

Trial Locations (19)

2100

Rigshospitalet, København Ø

5000

Odense Universitetshospital, Odense C

8200

Aarhus Universitetshospital Skejby, Aarhus N

9000

UZ Gent, Ghent

20133

Fond. IRCCS Istituto Nazionale Tumori, Milan

24127

Asst Papa Giovanni Xxiii, Bergamo

28040

START Madrid-FJD, Hospital Fundacion Jimenez Diaz, Madrid

29010

Hospital Clinico Universitario Virgen de la Victoria, Málaga

40138

Policlinico S.Orsola-Malpighi, Bologna

46010

Hospital Clinico Universitario de Valencia, Valencia

52621

Chaim Sheba Medical Center, Ramat Gan

80131

Istituto Nazionale Tumori Irccs Fondazione g. Pascale, Napoli

4941492

Rabin Medical Center-Beilinson Campus, Petah Tikva

9112001

Hadassah Ein Karem Hospital, Jerusalem

08035

Hospital Universitari Vall d'Hebron, Barcelona

08907

Hospital Duran i Reynals, Barcelona

LE1 5WW

The HOPE Clinical Trials Unit, Leicester

W1T 7HA

University College London Hospitals NHS Foundation Trust, London

NE1 4LP

The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03533283 - An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma | Biotech Hunter | Biotech Hunter