Trial record 1 of 1 for:
NCT05171647
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 |
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Recruitment Status :
Recruiting
First Posted : December 29, 2021
Last Update Posted : May 23, 2023
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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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), high-grade B-cell lymphoma, 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 |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Lymphoma
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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.
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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 :
- 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 :
- Objective response rate (ORR) [ Time Frame: Up to 2 years ]
- 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) ]
- Overall survival (OS) [ Time Frame: From randomization to death from any cause (up to 2 years) ]
- 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) ]
- Complete response rate (CRR) [ Time Frame: Up to 2 years ]
- 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) ]
- 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 ]
- 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 ]
- Incidence of adverse events (AEs) [ Time Frame: Up to 2 years ]
- 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 ]
- Serum concentration of mosunetuzumab [ Time Frame: Up to 2 years ]
- Plasma concentration of polatuzumab vedotin [ Time Frame: Up to 2 years ]
- Change from baseline in the EuroQol 5-dimension, 5-level questionnaire (EuroQol EQ 5D-5L) index-based scores [ Time Frame: Up to 2 years ]
- Change from baseline in the EuroQol EQ 5D-5L visual analog scale (VAS) scores [ Time Frame: Up to 2 years ]
- Incidence of anti-drug antibodies (ADAs) to mosunetuzumab [ Time Frame: Up to 2 years ]
- Incidence of anti-drug antibodies (ADAs) to polatuzumab vedotin [ Time Frame: Up to 2 years ]
Information from the National Library of Medicine
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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
- 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
- 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 an AIDS-defining opportunistic infection within the past 12 months
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
- 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
- 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
- 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
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
| Contact: Reference Study ID number: GO43643 https://forpatients.roche.com/ | 888-662-6728 | global-roche-genentech-trials@gene.com |
Locations
Show 48 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
| 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: | May 23, 2023 |
| Last Verified: | May 2023 |
| 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). |
| 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 Rituximab Gemcitabine |
Oxaliplatin Polatuzumab vedotin Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunoconjugates |