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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05171647




Registration number
NCT05171647
Ethics application status
Date submitted
6/12/2021
Date registered
29/12/2021

Titles & IDs
Public title
A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
Scientific title
A Randomized, Open-Label, Multicenter Phase III Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin in Comparison With Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
Secondary ID [1] 0 0
GO43643
Universal Trial Number (UTN)
Trial acronym
SUNMO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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
Treatment: Drugs - Polatuzumab vedotin
Treatment: Drugs - Tocilizumab
Treatment: Drugs - Rituximab
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Oxaliplatin

Experimental: M+P (Arm A) - Participants will receive subcutaneous (SC) mosunetuzumab plus intravenous (IV) polatuzumab vedotin (M+P). Mosunetuzumab will be administered on Days 1, 8, and 15 of Cycle 1, and thereafter on Day 1 of Cycles 2-8. Polatuzumab vedotin will be administered on Day 1 of each cycle up to Cycle 6. Cycle length = 21 days.

Active comparator: R-GemOx (Arm B) - Participants will receive IV rituximab, IV gemcitabine, and IV oxaliplatin (R-GemOx) on Day 1 of each cycle for 8 cycles. Cycle length = 14 days.


Treatment: Drugs: Mosunetuzumab
Participants will receive SC mosunetuzumab on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-8 (cycle length = 21 days).

Treatment: Drugs: Polatuzumab vedotin
Participants will receive IV polatuzumab vedotin every three weeks (Q3W) for 6 cycles (cycle length = 21 days).

Treatment: Drugs: Tocilizumab
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events.

Treatment: Drugs: Rituximab
Participants will receive IV rituximab on Day 1 of each cycle for 8 cycles (cycle length = 14 days).

Treatment: Drugs: Gemcitabine
Participants will receive IV gemcitabine on Day 1 of each cycle for 8 cycles (cycle length = 14 days).

Treatment: Drugs: Oxaliplatin
Participants will receive IV oxaliplatin on Day 1 of each cycle for 8 cycles (cycle length = 14 days).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS)
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression as determined by an independent review facility (IRF), or death due to any cause, whichever occurs first (up to 2.5 years)
Primary outcome [2] 0 0
Objective response rate (ORR) as determined by an independent review facility (IRF)
Timepoint [2] 0 0
Up to 2.5 years
Secondary outcome [1] 0 0
ORR as determined by the investigator
Timepoint [1] 0 0
Up to 2.5 years
Secondary outcome [2] 0 0
Duration of response (DOR)
Timepoint [2] 0 0
The time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, as determined by the investigator and IRF (up to 2.5 years)
Secondary outcome [3] 0 0
Overall survival (OS)
Timepoint [3] 0 0
From randomization to death from any cause (up to 2.5 years)
Secondary outcome [4] 0 0
PFS
Timepoint [4] 0 0
From randomization to the first occurrence of disease progression as determined by the investigator, or death due to any cause, whichever occurs first (up to 2.5 years)
Secondary outcome [5] 0 0
Complete response rate (CRR)
Timepoint [5] 0 0
Up to 2.5 years
Secondary outcome [6] 0 0
Duration of complete response (DOCR)
Timepoint [6] 0 0
From the first occurrence of a documented complete response (CR) to disease progression or death from any cause, whichever occurs first, as determined by IRF and the investigator (up to 2.5 years)
Secondary outcome [7] 0 0
Time to deterioration in physical functioning and fatigue as measured by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
Timepoint [7] 0 0
Up to 2.5 years
Secondary outcome [8] 0 0
Time to deterioration in lymphoma symptoms as measured by the functional assessment of cancer therapy lymphoma subscale (FACT-Lym LymS)
Timepoint [8] 0 0
Up to 2.5 years
Secondary outcome [9] 0 0
Incidence of adverse events (AEs)
Timepoint [9] 0 0
Up to 2.5 years
Secondary outcome [10] 0 0
Change from baseline in peripheral neuropathy as measured by the functional assessment of cancer therapy/gynecologic oncology group - neurotoxicity (FACT/GOG-NTX)
Timepoint [10] 0 0
Up to 2.5 years
Secondary outcome [11] 0 0
Serum concentration of mosunetuzumab
Timepoint [11] 0 0
Up to 2.5 years
Secondary outcome [12] 0 0
Plasma concentration of polatuzumab vedotin
Timepoint [12] 0 0
Up to 2.5 years
Secondary outcome [13] 0 0
Change from baseline in the EuroQol 5-dimension, 5-level questionnaire (EuroQol EQ 5D-5L) index-based scores
Timepoint [13] 0 0
Up to 2.5 years
Secondary outcome [14] 0 0
Change from baseline in the EuroQol EQ 5D-5L visual analog scale (VAS) scores
Timepoint [14] 0 0
Up to 2.5 years
Secondary outcome [15] 0 0
Incidence of anti-drug antibodies (ADAs) to mosunetuzumab
Timepoint [15] 0 0
Up to 2.5 years
Secondary outcome [16] 0 0
Incidence of anti-drug antibodies (ADAs) to polatuzumab vedotin
Timepoint [16] 0 0
Up to 2.5 years

Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
* CD20+ aggressive lymphoma as determined by the local hemopathology laboratory from the following diagnoses by 2016 World Health Organization classification of lymphoid neoplasms: DLBCL, not otherwise specified (NOS); high-grade B-cell lymphoma (NOS or double/triple hit); transformed follicular lymphoma; follicular lymphoma Grade 3b
* Have disease relapsed or refractory to at least one prior systemic therapy for aggressive non-Hodgkin's lymphoma (aNHL)
* Participants who have received only one prior line of therapy must be ineligible for autologous stem cell transplant (ASCT)
* Measurable disease
* Adequate hepatic, hematologic, and renal function
* Estimated creatinine clearance (CrCl) = 30 mL/min by Cockroft-Gault method or other institutional standard methods
* Negative HIV test at screening. Participants with a positive HIV test at screening are eligible provided that, prior to enrollment, they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count of at least 200 microliters, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or breast feeding, or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab, 9 months after the final dose of polatuzumab vedotin, 12 months after the final dose of rituximab, 6 months after the final dose of gemcitabine, 9 months after the final dose of oxaliplatin, and 3 months after the final dose of tocilizumab, as applicable
* Inability to comply with protocol-mandated activity restrictions
* Prior treatment with mosunetuzumab or other CD-20-directed bispecific antibodies, or R-GemOx or Gem-Ox
* Prior treatment with polatuzumab vedotin, with the following exceptions: participants who have a documented response (partial response or complete response) to polatuzumab vedotin and an absence of PD within 12 months from the last dose of polatuzumab vedotin; participants who received up to 2 doses of a polatuzumab vedotin-containing regimen as bridging to CAR-T therapy, and either has a documented disease control (stable disease, partial response, or complete response), or were not assessed for response following treatment with polatuzumab vedotin
* Contraindication to any component of the study treatment
* Grade > 1 peripheral neuropathy
* Participants with Grade > 1 persistent toxicity related to prior anti-lymphoma treatment (except for alopecia and anorexia, or other toxicities not considered a safety risk for the participant per investigator's judgment)
* Received anti-lymphoma treatments with monoclonal antibodies, radio-immunoconjugates or antibody-drug conjugates (ADCs) within 4 weeks before the first dose of study treatment
* Treatment with any chemotherapeutic agent, or treatment with any other anti-lymphoma agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to the first dose of study treatment
* Treatment with radiotherapy within 2 weeks prior to the first dose of study treatment
* ASCT within 100 days prior to the first study treatment administration
* Prior treatment with chimeric antigen receptor (CAR) T cell therapy within 30 days before the first study treatment administration
* Prior allogenic stem cell transplant (SCT)
* Have had a solid organ transplantation
* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
* History of confirmed progressive multifocal leukoencephalopathy
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombination antibody-related fusion proteins)
* History of other malignancy that could affect compliance with the protocol or interpretation of results, with the exception of malignancies with a negligible risk of metastasis or death
* Currently have or have had a past history of central nervous system (CNS) involvement of lymphoma
* Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits as judged by the investigator, or with a history of epilepsy who have had no seizures in the past 2 years while not receiving any anti-epileptic medications, are allowed
* Significant cardiovascular disease such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina
* Significant active pulmonary disease
* Participants with active symptoms of interstitial lung disease and/or pneumonitis, or those with a history of interstitial lung disease and/or pneumonitis within 6 months prior to the first dose of study treatment
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of the nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 2 weeks prior to the first study treatment administration
* Known or suspected chronic active Epstein-Barr virus (EBV) infection
* Recent major surgery within 4 weeks prior to the first study treatment administration
* Positive test results for chronic hepatitis B infection
* Acute or chronic hepatitis C virus (HCV) infection
* Have been administered a live, attenuated vaccine within 4 weeks before the first dose of study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
* Participants who have positive SARS-CoV-2 test within 7 days prior to enrollment (rapid antigen test result is acceptable)
* History of autoimmune disease
* Received investigational therapy, whether or not intended for lymphoma treatment, within 7 days prior to initiation of study treatment
* Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2027
Actual
Sample size
Target
222
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alaska
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Florida
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United States of America
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Indiana
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United States of America
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Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Rhode Island
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Argentina
State/province [10] 0 0
Buenos Aires
Country [11] 0 0
Argentina
State/province [11] 0 0
Ciudad Autonoma Buenos Aires
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Argentina
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Ciudad Autónoma de Buenos Aires
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Brazil
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PR
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Brazil
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RS
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Brazil
State/province [15] 0 0
SP
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Canada
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Saskatchewan
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China
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Chengdu City
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China
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Fuzhou City
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China
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Guangzhou City
Country [22] 0 0
China
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Hangzhou
Country [23] 0 0
China
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Nanchang
Country [24] 0 0
China
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Tianjin
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China
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Wuhan
Country [26] 0 0
China
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Zhengzhou
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Israel
State/province [27] 0 0
Beer Sheva
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Israel
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Kfar Saba
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Israel
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Tel Aviv
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Kanagawa
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Japan
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Mie
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Japan
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Miyagi
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Japan
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Osaka
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Japan
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Tokyo
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Japan
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Yamagata
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Korea, Republic of
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Busan
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Seoul
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Mexico
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Mexico CITY (federal District)
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Mexico
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Nuevo LEON
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Mexico
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Mexico City
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Mexico
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Mexico
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New Zealand
State/province [46] 0 0
Auckland
Country [47] 0 0
Peru
State/province [47] 0 0
Arequipa
Country [48] 0 0
Peru
State/province [48] 0 0
Lima
Country [49] 0 0
Peru
State/province [49] 0 0
Trujillo
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Niznij Novgorod
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Penza
Country [52] 0 0
Thailand
State/province [52] 0 0
Bangkok
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Thailand
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Chiang Mai
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Thailand
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Khon Kaen
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
State/province [57] 0 0
Kocaeli
Country [58] 0 0
Turkey
State/province [58] 0 0
Lzmir
Country [59] 0 0
Turkey
State/province [59] 0 0
Samsun

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
Reference Study ID number: GO43643 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728
Fax 0 0
Email 0 0
[email protected]
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/NCT05171647