← Back to Search

Monoclonal Antibodies

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

Phase 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Measurable disease

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

Must not have

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

Prior treatment with mosunetuzumab or other CD-20-directed bispecific antibodies, or R-GemOx or Gem-Ox

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare the effectiveness of mosunetuzumab+polatuzumab vedotin to rituximab+gemcitabine+oxaliplatin in people with relapsed or refractory DLBCL, high-grade B-cell lymphoma, transformed follicular lymphoma, and FL3B.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include allergic reactions related to infusion, liver problems due to hepatitis infection risk increase, nerve damage symptoms like numbness or tingling (peripheral neuropathy), blood disorders leading to increased bleeding or infection risk, fatigue from anemia or general drug effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer can be measured by tests.

Select...

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

Select...

I have had one treatment for my condition and cannot have a stem cell transplant.

Select...

My lymphoma is aggressive and CD20 positive.

Select...

My aggressive non-Hodgkin's lymphoma didn't respond to at least one treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have not been treated with mosunetuzumab, CD-20 bispecific antibodies, R-GemOx, or Gem-Ox.

Select...

I have not had major surgery in the last 4 weeks.

Select...

I have not had radiotherapy in the last 2 weeks.

Select...

I have received a solid organ transplant.

Select...

I have not received a live vaccine in the last 4 weeks and do not plan to during the study.

Select...

I have or might have had HLH.

Select...

I have or might have a long-term active Epstein-Barr virus infection.

Select...

I have a serious lung condition that is currently active.

Select...

I have moderate to severe numbness, tingling, or pain in my hands or feet.

Select...

My lymphoma has affected or is affecting my brain or spinal cord.

Select...

I had a stem cell transplant less than 100 days ago.

Select...

I am not allergic or unable to tolerate any part of the study treatment.

Select...

I do not have any current infections or recent major infections that required IV antibiotics or hospitalization.

Select...

I have hepatitis C.

Select...

I have been diagnosed with progressive multifocal leukoencephalopathy.

Select...

I have had a stem cell transplant from a donor.

Select...

I have a significant history of liver disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mosunetuzumab

2019

Completed Phase 2

~140

Tocilizumab

2012