A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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 (235)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Huntsville | Alabama | 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 | 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| Research Site | Aurora | Colorado | Withdrawn |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 | 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 | Recruiting |
| Research Site | Evanston | Illinois | Not Yet Recruiting |
| Research Site | Peoria | Illinois | Not Yet Recruiting |
| Research Site | Fort Wayne | Indiana | 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 | 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 | Recruiting |
| Research Site | Hackensack | New Jersey | Not Yet Recruiting |
| Research Site | New Brunswick | New Jersey | Not Yet Recruiting |
| Research Site | Albany | New York | Recruiting |
| Research Site | New Hyde Park | New York | Not Yet Recruiting |
| Research Site | New York | New York | Recruiting |
| Research Site | New York | New York | Not Yet Recruiting |
| Research Site | New York | New York | Recruiting |
| Research Site | Charlotte | North Carolina | Not Yet Recruiting |
+ 195 more sites — see the full list on the official registry below.
More AstraZeneca trials in South Korea
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.
View NCT06549595 on ClinicalTrials.gov ↗ ← All trials in South Korea