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Monoclonal Antibodies
Mosunetuzumab + Polatuzumab Vedotin for Aggressive B-Cell Lymphoma (SUNMO Trial)
Phase 3
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.5 years
Awards & highlights
SUNMO 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.Check my eligibility
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.See study design
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.
SUNMO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer can be measured by tests.
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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.
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My lymphoma is aggressive and CD20 positive.
Select...
My aggressive non-Hodgkin's lymphoma didn't respond to at least one treatment.
SUNMO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR) as determined by an independent review facility (IRF)
Progression-free survival (PFS)
Secondary outcome measures
Change from baseline in peripheral neuropathy as measured by the functional assessment of cancer therapy/gynecologic oncology group - neurotoxicity (FACT/GOG-NTX)
Change from baseline in the EuroQol 5-dimension, 5-level questionnaire (EuroQol EQ 5D-5L) index-based scores
Change from baseline in the EuroQol EQ 5D-5L visual analog scale (VAS) scores
+13 moreSUNMO 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
Completed Phase 4
~1840
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,090,001 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,718 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My cancer can be measured by tests.I haven't had treatments like monoclonal antibodies for my lymphoma in the last 4 weeks.I have not been treated with mosunetuzumab, CD-20 bispecific antibodies, R-GemOx, or Gem-Ox.You have had serious allergic reactions in the past to treatments called monoclonal antibodies or similar drugs.I have not had major surgery in the last 4 weeks.I can take care of myself and am up and about more than half of my waking hours.I have not had radiotherapy in the last 2 weeks.I have received a solid organ transplant.My liver, blood, and kidney functions are all within normal ranges.I do not have HIV, or if I do, it's well-controlled with treatment.I have hepatitis C.I haven't taken any cancer drugs within the last 4 weeks or 5 half-lives of the drug.I have had one treatment for my condition and cannot have a stem cell transplant.I have a serious lung condition that is currently active.You have a past or current autoimmune disease.I have moderate to severe numbness, tingling, or pain in my hands or feet.My lymphoma has affected or is affecting my brain or spinal cord.I had a stem cell transplant less than 100 days ago.I am not allergic or unable to tolerate any part of the study treatment.I do not have any current infections or recent major infections that required IV antibiotics or hospitalization.I have not had CAR T cell therapy in the last 30 days.My lymphoma is aggressive and CD20 positive.I have or might have a long-term active Epstein-Barr virus infection.I've had polatuzumab vedotin before but either responded well or used it briefly before CAR-T therapy without disease progression.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.I have or might have had HLH.I have had cancer before, but it's unlikely to interfere with this study.My aggressive non-Hodgkin's lymphoma didn't respond to at least one treatment.I have been diagnosed with progressive multifocal leukoencephalopathy.I have had a stem cell transplant from a donor.I have a significant history of liver disease.
Research Study Groups:
This trial has the following groups:- Group 1: R-GemOx (Arm B)
- Group 2: M+P (Arm A)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is R-GemOx (Arm B) a new medication?
"As of right now, 1225 different clinical studies are running that involve R-GemOx (Arm B). 342 of those active studies are in Phase 3. The majority of studies for R-GemOx (Arm B) are based in Guangzhou, Guangdong; however, 52797 total locations across the globe are conducting these sorts of trials."
Answered by AI
Does R-GemOx (Arm B) have FDA approval?
"R-GemOx (Arm B) has undergone Phase 3 clinical trials, meaning that there is available data supporting both its efficacy and safety. Our team at Power rates the safety of R-GemOx highly, with a score of 3."
Answered by AI
What is the total size of the study's test group?
"That is correct. The clinicaltrial.gov website shows that this trial, which was originally posted on April 25th, 2022, is still recruiting patients. They are looking for 222 participants at 1 site."
Answered by AI
What is the standard treatment that R-GemOx (Arm B) is used to manage?
"R-GemOx (Arm B) is the standard of care for diffuse large b-cell lymphoma (dlbcl). This treatment option is also effective for small cell lung cancer (sclc), systemic juvenile idiopathic arthritis (sjia), and head and neck carcinoma."
Answered by AI
Is it possible to sign up for this research program at the present time?
"The clinical trial, which is currently seeking 222 patients from 1 site, was originally posted on 4/25/2022 and last edited on 11/1/2022 according to information found on clinicaltrials.gov"
Answered by AI
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