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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05315713




Registration number
NCT05315713
Ethics application status
Date submitted
31/03/2022
Date registered
7/04/2022

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
CO43116
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin Lymphoma, Follicular Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mosunetuzumab SC
Treatment: Drugs - Tiragolumab
Treatment: Drugs - Atezolizumab
Other interventions - Tocilizumab

Experimental: Subcutaneous (SC) Mosunetuzumab in Combination with Intravenous (IV) Tiragolumab - Participants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days)

Experimental: Mosunetuzumab SC in Combination with Tiragolumab IV and Atezolizumab IV - Participants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days)


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

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

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

Other interventions: Tocilizumab
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Adverse Events (Phase 1b)
Timepoint [1] 0 0
Up to 90 days after the final dose of study treatment (up to Cycle 17; cycle length = 21 days)
Primary outcome [2] 0 0
Best Objective Response Rate (ORR) as Determined by the Investigator Using Lugano 2014 Criteria (Phase 2)
Timepoint [2] 0 0
Up to Cycle 17 (cycle length = 21 days)
Secondary outcome [1] 0 0
Best ORR as Determined by the Investigator Using Lugano 2014 Criteria (Phase 1b)
Timepoint [1] 0 0
Baseline up to approximately 4 years (assessed at screening, and then ever 3-6 months until disease progression, start of new anti-cancer therapy, or withdrawal)
Secondary outcome [2] 0 0
Best Complete Response (CR) Rate as Determined by the Investigator Using Lugano 2014 Criteria (Phase 1b and Phase 2)
Timepoint [2] 0 0
Baseline up to approximately 4 years (assessed at screening, and then ever 3-6 months until disease progression, start of new anti-cancer therapy, or withdrawal)
Secondary outcome [3] 0 0
Duration of Response (DOR) as Determined by the Investigator Using Lugano 2014 Criteria (Phase 1b and Phase 2)
Timepoint [3] 0 0
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)
Secondary outcome [4] 0 0
Progression-Free Survival (PFS) as Determined by the Investigator Using Lugano 2014 Criteria (Phase 2)
Timepoint [4] 0 0
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)
Secondary outcome [5] 0 0
Event-Free Survival (EFS) as Determined by the Investigator Using Lugano 2014 Criteria (Phase 2)
Timepoint [5] 0 0
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)
Secondary outcome [6] 0 0
Overall Survival (OS) (Phase 2)
Timepoint [6] 0 0
From the time of first study treatment to death from any cause (up to approximately 4 years)
Secondary outcome [7] 0 0
Percentage of Participants with Adverse Events (Phase 2)
Timepoint [7] 0 0
Up to 90 days after the final dose of study treatment (up to Cycle 17; cycle length = 21 days)
Secondary outcome [8] 0 0
Serum Concentration of Mosunetuzumab
Timepoint [8] 0 0
Up to Cycle 17 (cycle length = 21 days)
Secondary outcome [9] 0 0
Serum Concentration of Mosunetuzumab in Combination with Tiragolumab
Timepoint [9] 0 0
Up to Cycle 17 (cycle length = 17 days)
Secondary outcome [10] 0 0
Serum Concentration of Mosunetuzumab in Combination with Tiragolumab and Atezolizumab
Timepoint [10] 0 0
Up to Cycle 17 (cycle length = 21 days)

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/07/2023
Sample size
Target
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Eastern Health - Box Hill
Recruitment hospital [3] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
- Box Hill
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Rhode Island
Country [4] 0 0
Belgium
State/province [4] 0 0
Brugge
Country [5] 0 0
Belgium
State/province [5] 0 0
Bruxelles
Country [6] 0 0
Belgium
State/province [6] 0 0
Kortrijk
Country [7] 0 0
Belgium
State/province [7] 0 0
Yvoir
Country [8] 0 0
Canada
State/province [8] 0 0
Alberta
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Germany
State/province [10] 0 0
Essen
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Glasgow
Country [12] 0 0
United Kingdom
State/province [12] 0 0
London
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Plymouth
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05315713