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Non-Hodgkins LymphomaPhase 1/2NCT03533283

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

A Phase 1/2 study testing Glofitamab, Atezolizumab and Obinutuzumab in people with Non-Hodgkins Lymphoma, run by Hoffmann-La Roche at 20 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkins Lymphoma
What is being tested?
Glofitamab, Atezolizumab and Obinutuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
211 participants
Where
20 sitesin 7 countries
Study dates
8 May 2018to 22 Oct 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least two measurable target lesions
  • Able to provide two fresh tumor biopsies (baseline and on-treatment)
  • Main Exclusion Criteria
  • Participants with Chronic Lymphocytic Leukemia (CLL), acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma, Richter's transformation, CD20-positive ALL, Burkitt lymphoma, or lymphoplasmacytic lymphoma
  • Current > Grade 1 peripheral neuropathy (only for participants being treated in the polatuzumab vedotin arm)
  • Patients with known active infection, or reactivation of a latent infection within 4 weeks prior to Obinutuzumab (Gpt) infusion
Show all 24Show fewer
  • Patient with history of confirmed progressive multifocal leukoencephalopathy (PML)
  • History of leptomeningeal disease
  • Current or past history of central nervous system (CNS) lymphoma
  • Current or past history of CNS disease
  • Major surgery or significant traumatic injury </=28 days prior to Gpt infusion
  • Significant cardiovascular disease or significant pulmonary disease
  • Active or history of autoimmune disease or immune deficiency (with exceptions, e.g. hypothyroidism and Diabetes mellitus Type 1)
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • Treatment with any other standard anti-cancer radiotherapy / chemotherapy including investigational therapy within 4 weeks prior to Gpt infusion
  • Prior solid organ transplantation
  • Prior allogenic stem cell transplant (SCT)
  • Autologous SCT within 100 days prior to Gpt infusion
  • Documented refractoriness to an obinutuzumab-monotherapy regimen
  • Prior treatment with anti-cancer/lymphoma therapies and systemic immunotherapeutic/immunostimulating agents within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to Gpt infusion
  • Any history of immune related >/= Grade 3 adverse events (AE) with the exception of endocrinopathy managed with replacement therapy
  • Ongoing corticosteroid use >25 milligrams/day of prednisone or equivalent within 4 weeks prior to and during study treatment
  • Treatment with systemic immunosuppressive medication
  • Administration of a live, attenuated vaccine within 4 weeks prior to Gpt infusion or anticipation that such a live attenuated vaccine will be required during the study or within 5 months after last dose of study treatment

Who cannot join

  • Circulating lymphoma cells, defined by out of range (high) absolute lymphocyte count and/or the presence of abnormal/malignant cells in the peripheral blood differential signifying circulating lymphoma cell
  • Participants who have had splenectomy or functional asplenia that could compromise protocol objectives

Trial locations and contacts

20 sites in 7 countries.

20 sites in 7 countries

Spain5 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Duran i Reynals

    Barcelona, 08907

  • START Madrid-FJD, Hospital Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Italy4 sites

  • Asst Papa Giovanni Xxiii

    Bergamo, Lombardy, 24127

  • Policlinico S.Orsola-Malpighi

    Bologna, Emilia-Romagna, 40138

  • Fond. IRCCS Istituto Nazionale Tumori

    Milan, Lombardy, 20133

  • Istituto Nazionale Tumori Irccs Fondazione g. Pascale

    Naples, Campania, 80131

Other trials in Italy

Denmark3 sites

  • Aarhus Universitetshospital Skejby

    Aarhus N, 8200

  • Rigshospitalet

    København Ø, 2100

  • Odense Universitetshospital

    Odense C, 5000

Other trials in Denmark

Israel3 sites

  • Hadassah Ein Karem Hospital

    Jerusalem, 9112001

  • Rabin Medical Center-Beilinson Campus

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center

    Ramat Gan, 52621

Other trials in Israel

United Kingdom3 sites

  • The HOPE Clinical Trials Unit

    Leicester, LE1 5WW

  • University College London Hospitals NHS Foundation Trust

    London, W1T 7HA

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, NE1 4LP

Other trials in United Kingdom

United States1 site

  • Novant Health Cancer Institute

    Charlotte, North Carolina, 28204

Other trials in United States

Belgium1 site

  • UZ Gent

    Ghent, 9000

Other trials in Belgium

About this study

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

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.

Being tested
Glofitamab, Atezolizumab, Obinutuzumab, Tocilizumab, Polatuzumab Vedotin
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GlofitamabDrug

    Also called RO7082859, Columvi

    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.

  • AtezolizumabDrug

    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).

  • ObinutuzumabDrug

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

  • TocilizumabDrug

    Also called Actemra

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

  • Polatuzumab VedotinDrug

    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-IAB22M2CDrug

    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.

Study groups in NCT03533283
Study groupRoleWhat they receive
AtezolizumabExperimentalParticipants will receive Glofitamab in combination with Atezolizumab up to the maximum tolerated dose (MTD).
Receives: Drug: Glofitamab; Drug: Atezolizumab; Drug: Obinutuzumab; Drug: Tocilizumab
Polatuzumab VedotinExperimentalParticipants will receive Glofitamab in combination with polatuzumab vedotin up to the MTD.
Receives: Drug: Glofitamab; Drug: Obinutuzumab; Drug: Tocilizumab; Drug: Polatuzumab Vedotin
Imaging Sub-studyExperimentalParticipants will undergo positive-emission tomography/computed tomography (PET/CT) at screening, followed by an "Imaging Cycle," to replace Cycle 1 of the main study. Eligible participants will have the option roll-over to the atezolizumab arm of the main study from Cycle 2 onwards.
Receives: Drug: Glofitamab; Drug: Obinutuzumab; Drug: 89Zr-Df-IAB22M2C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best Objective Response Rate (ORR) as Measured by Independent Review Committee (IRC)

    Measured: Baseline until the end of treatment (13 to 14 months), then ever 3 months until end of study visit (to occur within 4 weeks of disease progression)

  2. Dose Limiting Toxicities (DLTs)

    Measured: Atezolizumab Arm: During DLT period of 21 days (or up to 42 days in the case of cycle delay), starting on Day 1, Cycle 2; Polatuzumab Vedotin Arm: During 5-week DLT period starting Cycle 1, Day 8

Secondary outcomes (26)

  1. Best ORR as Measured by Investigator

    Measured: Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression)

  2. Best Complete Response (CR) Rate, as Assessed by Fluorodeoxyglucose-Positron Emission Tomography/Computed Tomography (FDG-PET/CT) Scan

    Measured: Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression)

  3. Duration of Complete Response (DOCR)

    Measured: Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression)

  4. Duration of Response (DOR)

    Measured: Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression)

  5. Progression-Free Survival (PFS)

    Measured: Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression)

  6. Event-Free Survival (EFS)

    Measured: Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression)

  7. Time to First Complete Response (TFCR)

    Measured: Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression)

  8. Time to First Overall Response (TFOR)

    Measured: Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression)

  9. Overall Survival (OS)

    Measured: Baseline through end of survival follow-up phase (survival follow-up is every 3 months until death, lost to follow-up, withdrawal of consent, or study termination)

  10. Percentage of Participants with Adverse Events (AEs)

    Measured: Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression)

  11. Incidence and Severity of Cytokine Release Syndrome (CRS) Following Glofitamab Administration

    Measured: Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression)

  12. Anti-Drug Antibody (ADA) Formation

    Measured: Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression)

  13. Elimination Half-Life (T1/2) of Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin

    Measured: At pre-defined intervals through the end of study (EoS) visit (to occur within 4 weeks of disease progression)

  14. Area Under the Concentration-Time Curve (AUC) for Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin

    Measured: At pre-defined intervals through the end of study (EoS) visit (to occur within 4 weeks of disease progression)

  15. Time to Maximum Observed Serum Concentration (Tmax) of Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin

    Measured: At pre-defined intervals through the end of study (EoS) visit (to occur within 4 weeks of disease progression)

  16. Maximum Observed Serum Concentration (Cmax) of Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin

    Measured: At pre-defined intervals through the end of study (EoS) visit (to occur within 4 weeks of disease progression)

  17. Minimum Serum Concentration (Cmin) of Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin

    Measured: At pre-defined intervals through the end of study (EoS) visit (to occur within 4 weeks of disease progression)

  18. Clearance (CL) of Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin

    Measured: At pre-defined intervals through the end of study (EoS) visit (to occur within 4 weeks of disease progression)

  19. Volume of Distribution at Steady-State (Vss) of Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin

    Measured: At pre-defined intervals through the end of study (EoS) visit (to occur within 4 weeks of disease progression)

  20. CD8-Positive T Cell Proliferation

    Measured: At pre-defined intervals during the study treatment period (up to 17 cycles; Cycle = 21 days)

  21. CD20-Positive B-Cell Reduction

    Measured: At pre-defined intervals during the study treatment period (up to 17 cycles; Cycle = 21 days)

  22. SUVmax of 89Zr-Df-IAB22M2C (Imaging Sub-study)

    Measured: From baseline to Day 13

  23. SUVpeak of 89Zr-Df-IAB22M2C (Imaging Sub-study

    Measured: From baseline to Day 13

  24. SUVmean of 89Zr-Df-IAB22M2C (Imaging Sub-study)

    Measured: From baseline to Day 13

  25. Tumor Volume Based on 89Zr-Df-IAB22M2C PET-uptake (Imaging Sub-study)

    Measured: From baseline to Day 13

  26. Quantitation of CD8+ Cells on Biopsy Samples (Imaging Sub-study)

    Measured: From baseline to Day 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2018
  2. Study start8 May 2018
  3. Primary completion22 Oct 2026
  4. Study completion22 Oct 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03533283
Sponsor's protocol ID
NP39488
Status last verified
Oct 2026
First submitted
4 May 2018
Last updated
2 Nov 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Publications

  • Hutchings M, Sureda A, Bosch F, Larsen TS, Corradini P, Avigdor A, Terol MJ, Dominguez AR, Pinto A, Skarbnik A, Cordoba R, Jorgensen JM, Zinzani PL, Leung W, Bottos A, Li D, Relf J, Tandon M, Sellam G, Gritti G. Efficacy and Safety of Glofitamab Plus Polatuzumab Vedotin in Relapsed/Refractory Large B-Cell Lymphoma Including High-Grade B-Cell Lymphoma: Results From a Phase Ib/II Trial. J Clin Oncol. 2025 Dec 20;43(36):3788-3798. doi: 10.1200/JCO-25-00992. Epub 2025 Oct 20.

    PubMed 41115257

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Glofitamab, Atezolizumab and Obinutuzumab in people with Non-Hodgkins Lymphoma, run by Hoffmann-La Roche at 20 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Spain, Italy, Denmark, Israel, United Kingdom and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Objective Response Rate (ORR) as Measured by Independent Review Committee (IRC) (time frame: Baseline until the end of treatment (13 to 14 months), then ever 3 months until end of study visit (to occur within 4 weeks of disease progression)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03533283, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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