Mosunetuzumab + Polatuzumab Vedotin for Aggressive B-Cell Lymphoma
(SUNMO Trial)

Recruiting in Palo Alto (17 mi)

+93 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

This trial is for adults with certain aggressive B-cell non-Hodgkin's lymphomas that have come back or didn't respond to previous treatments. They should be relatively active (ECOG 0-2), not eligible for stem cell transplant if only one prior therapy was received, and must have measurable disease. People with HIV can join if stable on treatment, but those with recent other cancer treatments, major infections, heart or lung issues, CNS involvement of lymphoma, severe allergies to monoclonal antibodies or autoimmune diseases cannot participate.

Inclusion Criteria

My cancer can be measured by tests.

I can take care of myself and am up and about more than half of my waking hours.

My liver, blood, and kidney functions are all within normal ranges.

+4 more

Exclusion Criteria

I have a history of CNS disease but have been stable for the past 2 years without medication.

I do not have severe heart problems like recent heart attacks or unstable heart rhythms.

I haven't had treatments like monoclonal antibodies for my lymphoma in the last 4 weeks.

+27 more

Participant Groups

The study tests the effectiveness and safety of mosunetuzumab combined with polatuzumab vedotin against a standard regimen of rituximab plus gemcitabine and oxaliplatin in participants with relapsed/refractory aggressive B-cell non-Hodgkin's lymphoma. It aims to see which combination works better for these conditions.

2Treatment groups

Experimental Treatment

Active Control

Group I: M+P (Arm A)Experimental Treatment3 Interventions

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.

Group II: R-GemOx (Arm B)Active Control3 Interventions

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.

Mosunetuzumab is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Lunsumio for: