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ACTIVE NOT RECRUITING
NCT03533283
PHASE1/PHASE2

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This is an open-label, single arm, multicenter, dose finding, Phase Ib study in order to assess the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) for this combination treatment and to evaluate the general safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and preliminary anti-tumor activity of this combination treatment in adult patients. This study includes an additional open-label imaging feasibility sub-study using a tracer in adult participants with relpased/refractory B-cell non-Hodgkin's lymphoma to image CD8+T-cells at baseline and after treatment with glofitamab, including pre-treatment with obinutuzumab.

Official title: An Open-Label, Multi-Center, Phase IB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin (Plus a Single Pre-Treatment Dose of Obinutuzumab) in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

211

Start Date

2018-05-08

Completion Date

2026-10-16

Last Updated

2026-04-06

Healthy Volunteers

No

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.

Locations (19)

UZ Gent

Ghent, Belgium

Aarhus Universitetshospital Skejby

Aarhus N, Denmark

Rigshospitalet

København Ø, Denmark

Odense Universitetshospital

Odense C, Denmark

Hadassah Ein Karem Hospital

Jerusalem, Israel

Rabin Medical Center-Beilinson Campus

Petah Tikva, Israel

Chaim Sheba Medical Center

Ramat Gan, Israel

Istituto Nazionale Tumori Irccs Fondazione g. Pascale

Naples, Campania, Italy

Policlinico S.Orsola-Malpighi

Bologna, Emilia-Romagna, Italy

Asst Papa Giovanni Xxiii

Bergamo, Lombardy, Italy

Fond. IRCCS Istituto Nazionale Tumori

Milan, Lombardy, Italy

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Duran i Reynals

Barcelona, Spain

START Madrid-FJD, Hospital Fundacion Jimenez Diaz

Madrid, Spain

Hospital Clinico Universitario Virgen de la Victoria

Málaga, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

The HOPE Clinical Trials Unit

Leicester, United Kingdom

University College London Hospitals NHS Foundation Trust

London, United Kingdom

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom