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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 (SUNMO)

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ClinicalTrials.gov Identifier: NCT05171647
Recruitment Status : Recruiting
First Posted : December 29, 2021
Last Update Posted : June 21, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will assess the efficacy and safety of mosunetuzumab in combination with polatuzumab vedotin (M+P) in participants with relapsed or refractory (R/R) diffuse-large B-cell lymphoma (DLBCL), transformed follicular lymphoma (trFL) and FL Grade 3B (FL3B) in comparison with a commonly used regimen in this participant population, rituximab, gemcitabine and oxaliplatin (R-GemOx).

Condition or disease Intervention/treatment Phase
Non-Hodgkin Lymphoma Drug: Mosunetuzumab Drug: Polatuzumab vedotin Drug: Tocilizumab Drug: Rituximab Drug: Gemcitabine Drug: Oxaliplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 25, 2022
Estimated Primary Completion Date : September 29, 2023
Estimated Study Completion Date : March 27, 2026


Arm Intervention/treatment
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.
Drug: 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).

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

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

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

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

Drug: Oxaliplatin
Participants will receive IV oxaliplatin on Day 1 of each cycle for 8 cycles (cycle length = 14 days).




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 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 years) ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Up to 2 years ]
  2. Duration of response (DOR) [ Time Frame: 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 years) ]
  3. Overall survival (OS) [ Time Frame: From randomization to death from any cause (up to 2 years) ]
  4. PFS [ Time Frame: 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 years) ]
  5. Complete response rate (CRR) [ Time Frame: Up to 2 years ]
  6. Duration of complete response (DOCR) [ Time Frame: 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 years) ]
  7. Time to deterioration in physical functioning and fatigue as measured by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 [ Time Frame: Up to 2 years ]
  8. Time to deterioration in lymphoma symptoms as measured by the functional assessment of cancer therapy lymphoma subscale (FACT-Lym LymS) [ Time Frame: Up to 2 years ]
  9. Incidence of adverse events (AEs) [ Time Frame: Up to 2 years ]
  10. Change from baseline in peripheral neuropathy as measured by the functional assessment of cancer therapy/gynecologic oncology group - neurotoxicity (FACT/GOG-NTX) [ Time Frame: Up to 2 years ]
  11. Serum concentration of mosunetuzumab [ Time Frame: Up to 2 years ]
  12. Plasma concentration of polatuzumab vedotin [ Time Frame: Up to 2 years ]
  13. Change from baseline in the EuroQol 5-dimension, 5-level questionnaire (EuroQol EQ 5D-5L) index-based scores [ Time Frame: Up to 2 years ]
  14. Change from baseline in the EuroQol EQ 5D-5L visual analog scale (VAS) scores [ Time Frame: Up to 2 years ]
  15. Incidence of anti-drug antibodies (ADAs) to mosunetuzumab [ Time Frame: Up to 2 years ]
  16. Incidence of anti-drug antibodies (ADAs) to polatuzumab vedotin [ Time Frame: Up to 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • Life expectancy of at least 12 weeks
  • 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); trFL R/R to standard therapies to trFL; FL3B
  • Received at least one prior systemic therapy for aggressive non-Hodgkin's lymphoma (aNHL)
  • Have either relapsed or have become refractory to a prior regimen must meet the following criteria: relapsed to prior regimen(s) after having a documented history of response (CR or PR) of at least 6 months in duration from completion of regimen(s); refractory to any prior regimen, defined as no response to the prior therapy, or progression within 6 months of completion of the last dose of therapy
  • Participants who have received only one prior line of therapy must be ineligible for autologous stem cell transplant (ASCT)
  • Measurable disease, defined as at least 1 bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or at least 1 bi-dimensionally measurable extra nodal lesion, defined as > 1.0 cm in its longest dimension
  • Have a pathology report for the initial histopathology diagnosis and the most recent histopathology diagnosis prior to entering the study
  • Representative tumor specimen and the corresponding pathology report available for confirmation of diagnosis as well as for biomarker analysis
  • Adequate hepatic, hematologic, and renal function

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, polatuzumab vedotin, or R-GemOx or Gem-Ox
  • Contraindication to any component of the study treatment
  • Grade > 1 peripheral neuropathy
  • 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-cancer 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 malignancy that has been treated with curative intent within >/= 2 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.. 5-year overall survival rate > 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage 1 uterine cancer
  • Currently have or have had a past history of central nervous system (CNS) involvement of lymphoma
  • History of CNS disease which was symptomatic or required treatment in the past 1 year, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
  • 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
  • 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
  • History of HIV 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
  • History of autoimmune disease
  • Received systemic immunosuppressive medications (including, but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents) with the exception of corticosteroid treatment </= 10 mg/day prednisone or equivalent within 2 weeks prior to first dose of study treatment
  • 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
  • Any serious medical condition or abnormality in clinical laboratory tests that precludes the participant's safe participation in and in the completion of the study, or which could affect compliance with the protocol or interpretation of results

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05171647


Contacts
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Contact: Reference Study ID number: GO43643 https://forpatients.roche.com/ 888-662-6728 global-roche-genentech-trials@gene.com

Locations
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Argentina
Instituto Alexander Fleming Recruiting
Buenos Aires, Argentina, 1426
Fundaleu; Haematology Recruiting
Buenos Aires, Argentina, C1114AAN
Israel
Ichilov Sourasky Medical Center; Heamatology Recruiting
Tel Aviv, Israel, 6423906
Korea, Republic of
Pusan National University Hospital Recruiting
Busan, Korea, Republic of, 49241
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of, 35015
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT05171647    
Other Study ID Numbers: GO43643
First Posted: December 29, 2021    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Rituximab
Oxaliplatin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents