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Non-Hodgkin Lymphoma, Follicular LymphomaPhase 1/2NCT05315713

An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Combination With Tiragolumab With or Without Atezolizumab in Participants With B-Cell Non-Hodgkin Lymphoma

A Phase 1/2 study testing Mosunetuzumab SC, Tiragolumab and Atezolizumab in people with Non-Hodgkin Lymphoma, Follicular Lymphoma, run by Hoffmann-La Roche at 17 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will evaluate the safety, efficacy, and pharmacokinetics of mosunetuzumab in combination with tiragolumab, with or without atezolizumab, in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) who have received at least two previous lines of… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Mosunetuzumab SC, Tiragolumab and Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
17 sitesin 6 countries
Study dates
10 May 2022to 19 Jul 2023
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Aged >/= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Life expectancy of at least 12 weeks
  • Histologically documented FL or DLBCL that has relapsed or failed to respond to at least two prior systemic treatment regimens and for which no suitable therapy of curative intent or higher priority exists (e.g., standard chemotherapy, ASCT, CAR T cells)
  • At least one bi-dimensionally measurable (> 1.5 cm) nodal lesion, or at least one bi-dimensionally measurable (> 1.0 cm) extranodal lesion
  • Participants with FL (including trFL) for whom a bone marrow biopsy and aspirate can be collected
  • Adequate hematologic and organ function

Who cannot join

  • Received any of the following treatments prior to study entry: mosunetuzumab or other CD20/CD3-directed bispecific antibodies; tiragolumab or other anti-TIGIT agent; allogenic SCT; solid organ transplantation
  • Currently eligible for autologous SCT
  • Current or past history of CNS lymphoma or leptomeningeal infiltration
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
  • Contraindication to atezolizumab (if applicable) or tocilizumab
  • Clinically significant toxicities from prior treatment have not resolved to Grade </= 1 (per NCI CTCAE v5.0) prior to the first study drug administration with exceptions defined by the protocol
Show all 12Show fewer
  • Treatment-emergent immune-mediated adverse events associated with prior immunotherapeutic agents as defined by the protocol
  • Evidence of any significant, concomitant disease as defined by the protocol
  • Major surgery within 4 weeks prior to first study treatment administration, with the exception of protocol-mandated procedures (e.g., tumor biopsies and bone marrow biopsies)
  • Significant cardiac, pulmonary, CNS, or liver disease, or known active infections
  • History of other malignancy that could affect compliance with the protocol or interpretation of results
  • History of autoimmune disease with exceptions as defined in the protocol

Trial locations and contacts

17 sites in 6 countries.

17 sites in 6 countries

Belgium4 sites

  • AZ Sint Jan Brugge Oostende AV

    Bruges, 8000

  • Institut Jules Bordet

    Brussels, 1000

  • AZ Groeninge

    Kortrijk, 8500

  • CHU UCL Namur - Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

United Kingdom4 sites

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • Royal Marsden Hospital - Institute of Cancer Research - Chelsea

    London, SE3 6JJ

  • Plymouth Hospitals NHS Trust - Derriford Hospital

    Plymouth

  • Royal Marsden Hospital - Institute of Cancer Research - Sutton

    Sutton, SM2 5PT

Other trials in United Kingdom

United States3 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Lifespan Cancer Institute

    Providence, Rhode Island, 02905

Other trials in United States

Australia3 sites

  • Eastern Health

    Box Hill, Victoria

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

Other trials in Australia

Canada2 sites

  • Tom Baker Cancer Centre-Calgary

    Calgary, Alberta, T2N 4N2

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1Z5

Other trials in Canada

Germany1 site

  • Universitaet Duisburg-Essen

    Essen, 45122

Other trials in Germany

About this study

Official title: A Phase Ib/II Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Combination With Tiragolumab With or Without Atezolizumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

This study will evaluate the safety, efficacy, and pharmacokinetics of mosunetuzumab in combination with tiragolumab, with or without atezolizumab, in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) who have received at least two previous lines of systemic therapy.

Being tested
Mosunetuzumab SC, Tiragolumab, Atezolizumab, Tocilizumab
Keywords
B-Cell Non-Hodgkin Lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, B-Cell

What participants receive

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

  • Mosunetuzumab SCDrug

    Participants will receive SC mosunetuzumab for up to 17 treatment cycles (cycle length = 21 days)

  • TiragolumabDrug

    Participants will receive IV tiragolumab every 3 weeks (Q3W) for up to 17 treatment cycles (cycle length = 21 days)

  • AtezolizumabDrug

    Participants will receive IV atezolizumab Q3W for up to 17 treatment cycles (cycle length = 21 days)

  • TocilizumabOther

    Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events

Study groups in NCT05315713
Study groupRoleWhat they receive
Subcutaneous (SC) Mosunetuzumab in Combination with Intravenous (IV) TiragolumabExperimentalParticipants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days)
Receives: Drug: Mosunetuzumab SC; Drug: Tiragolumab; Other: Tocilizumab
Mosunetuzumab SC in Combination with Tiragolumab IV and Atezolizumab IVExperimentalParticipants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days) Note: This arm did not enroll any participants.
Receives: Drug: Mosunetuzumab SC; Drug: Tiragolumab; Drug: Atezolizumab; Other: Tocilizumab

What is being measured

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

  1. Percentage of Participants With Adverse Events - Phase 1b

    Measured: From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)

  2. Best Objective Response Rate (ORR) as Determined by the Investigator Using Lugano 2014 Criteria - Phase 2

    Measured: Up to Cycle 17 (cycle length = 21 days)

Secondary outcomes (8)

  1. Best ORR as Determined by the Investigator Using Lugano 2014 Criteria - Phase 1b

    Best ORR is defined as the fraction of participants with complete response (CR) or partial response (PR) at any time as determined by the investigator using Lugano 2014 criteria.

    Measured: Assessed at screening and then every 3-6 months until disease progression, start of new anti-cancer therapy, or withdrawal (through Cycle 8; cycle length = 21 days)

  2. Serum Concentration of Mosunetuzumab - Phase 1b

    Measured: Cycle 1 Day 1 - Cycle 8 Day 1 (cycle length = 21 days)

  3. Best Complete Response (CR) Rate as Determined by the Investigator Using Lugano 2014 Criteria - Phase 1b

    Measured: Assessed at screening and then every 3-6 months until disease progression, start of new anti-cancer therapy, or withdrawal (through Cycle 8; cycle length = 21 days)

  4. Duration of Response (DOR) as Determined by the Investigator Using Lugano 2014 Criteria - Phase 1b and Phase 2

    Measured: From the first occurrence of a documented response (CR or partial response (PR)) to disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 4 years)

  5. Progression-Free Survival (PFS) as Determined by the Investigator Using Lugano 2014 Criteria - Phase 2

    Measured: From the first study treatment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 4 years)

  6. Event-Free Survival (EFS) as Determined by the Investigator Using Lugano 2014 Criteria - Phase 2

    Measured: From the first study treatment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 4 years)

  7. Overall Survival (OS) - Phase 2

    Measured: From the time of first study treatment to death from any cause (up to approximately 4 years)

  8. Percentage of Participants With Adverse Events - Phase 2

    Measured: From the start of treatment until 90 days after the final dose of study treatment

Timeline

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

  1. First posted7 Apr 2022
  2. Study start10 May 2022
  3. Primary completion19 Jul 2023
  4. Study completion19 Jul 2023

Why it stopped: Study was terminated due to Sponsor decision.

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05315713
Sponsor's protocol ID
CO43116
Status last verified
Sep 2024
First submitted
31 Mar 2022
Last updated
4 Oct 2024
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Mosunetuzumab SC, Tiragolumab and Atezolizumab in people with Non-Hodgkin Lymphoma, Follicular Lymphoma, run by Hoffmann-La Roche at 17 sites in 6 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 7 inclusion and 12 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: stopped early, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Belgium, United Kingdom, United States, Australia, Canada and 1 more country. 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?

Yes. Results are posted in the registry (first posted 4 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Adverse Events - Phase 1b (time frame: From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)). 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 NCT05315713.

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 4 Oct 2024; AzTrials last refreshed its copy on 29 Oct 2026.

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