Surovatamig: a fully human bispecific monoclonal IgG4 antibody
R-CHOP: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
R-CVP: Rituximab, Cyclophosphamide, Vincristine and Prednisone
BR: Bendamustine, Rituximab
Study summary
This is a global, randomised, Phase III, multicentre, open-label study evaluating the efficacy, safety and the degree of added benefit of the Surovatamig (AZD0486) plus rituximab combination compared to Investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated FL.
Eligibility
Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion Criteria:
1. Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.
2. Histologically confirmed diagnosis of classic FL per WHO 2022 classification
3. ECOG performance status of 0 to 2
4. No prior systemic lymphoma-directed therapy
5. Need for systemic treatment meeting at least 1 GELF criteria
6. FDG-avid and measurable disease
7. Stage II to IV and FLIPI 2-5 \[Phase III only\]
8. Adequate liver, hematological, renal and cardiac function.
The above is a summary, other inclusion criteria details may apply
Exclusion Criteria:
1. Follicular large B-cell lymphoma (WHO 2022 classification), formerly Follicular lymphoma Grade 3B (WHO 2016 classification) or suspicion for histologic transformation to high-grade/aggressive lymphoma
2. Contra-indication to BR, RCVP, and R-CHOP
3. Participants with or history of CNS lymphoma
4. History of a clinically relevant CNS medical condition or pathology that required treatment in the preceding year, is currently symptomatic or that which the treating investigator considers to have the potential to interfere with the evaluation of safety
5. Presence of \>5000 circulating lymphoma cells
6. Active or uncontrolled infection (including EBV) requiring systemic therapy and which places participant at unacceptable risk if he/she were to participate in the study. If a participant has a history of COVID-19 within 1 month of C1D1 or contracts COVID while on study treatment, participant must have 2 consecutive negative tests (PCR testing is preferable) performed at least 48 hours apart prior to resuming dosing. All symptoms related to COVID-19 infection should have fully resolved before initiating or resuming treatment
7. Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)
The above is a summary, other exclusion criteria details may apply
Primary outcome measure(s)
SRI Primary: Incidence, nature and severity of AEs and SAEs. Incidence and nature of study drug discontinuations, dose reductions, and dose delays due to AEs — Up to 10 years Frequency, severity, and relationship to study drug of AEs and SAEs; dose modifications; changes in physical examination and safety procedures.
SRI Primary: Determination of the recommended Phase III dose (RP3D) — Up to 1 year The RP3D will be the dose of Surovatamig selected for the Phase 3 part based on safety data compiled during the safety run-in part
Phase 3 Dual Primary: To demonstrate the superiority of Surovatamig plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy — Up to 10 years PFS, based on Lugano 2014 Response Criteria, as assessed by BICR.
Phase 3 Dual Primary: To demonstrate the superiority of Surovatamig plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy — Up to 10 years ORR at EoI, based on Lugano 2014 Response Criteria, as assessed by BICR.
Trial sites (228)
Facility
City
Region
Status
Research Site
Huntsville
Alabama
Not Yet Recruiting
Research Site
Anchorage
Alaska
Recruiting
Research Site
Phoenix
Arizona
Not Yet Recruiting
Research Site
Clovis
California
Not Yet Recruiting
Research Site
Los Alamitos
California
Not Yet Recruiting
Research Site
San Diego
California
Not Yet Recruiting
Research Site
Santa Monica
California
Not Yet Recruiting
Research Site
Aurora
Colorado
Withdrawn
Research Site
New Haven
Connecticut
Not Yet Recruiting
Research Site
Newark
Delaware
Not Yet Recruiting
Research Site
Jacksonville
Florida
Not Yet Recruiting
Research Site
Atlanta
Georgia
Not Yet Recruiting
Research Site
Macon
Georgia
Not Yet Recruiting
Research Site
Evanston
Illinois
Not Yet Recruiting
Research Site
Peoria
Illinois
Not Yet Recruiting
Research Site
Fort Wayne
Indiana
Not Yet Recruiting
Research Site
Des Moines
Iowa
Not Yet Recruiting
Research Site
Iowa City
Iowa
Not Yet Recruiting
Research Site
Lexington
Kentucky
Not Yet Recruiting
Research Site
Louisville
Kentucky
Not Yet Recruiting
Research Site
Baton Rouge
Louisiana
Not Yet Recruiting
Research Site
Baltimore
Maryland
Not Yet Recruiting
Research Site
Bethesda
Maryland
Not Yet Recruiting
Research Site
Columbia
Maryland
Not Yet Recruiting
Research Site
Boston
Massachusetts
Not Yet Recruiting
Research Site
Boston
Massachusetts
Not Yet Recruiting
Research Site
Ann Arbor
Michigan
Not Yet Recruiting
Research Site
Detroit
Michigan
Withdrawn
Research Site
Ypsilanti
Michigan
Not Yet Recruiting
Research Site
Saint Paul
Minnesota
Not Yet Recruiting
Research Site
Chesterfield
Missouri
Not Yet Recruiting
Research Site
Springfield
Missouri
Not Yet Recruiting
Research Site
Hackensack
New Jersey
Not Yet Recruiting
Research Site
New Brunswick
New Jersey
Not Yet Recruiting
Research Site
Albany
New York
Not Yet Recruiting
Research Site
New Hyde Park
New York
Not Yet Recruiting
Research Site
New York
New York
Not Yet Recruiting
Research Site
New York
New York
Not Yet Recruiting
Research Site
New York
New York
Not Yet Recruiting
Research Site
Charlotte
North Carolina
Not Yet Recruiting
+ 188 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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