Study of Surovatamig Plus Rituximab for Untreated Follicular Lymphoma
This study is looking at a new treatment, Surovatamig (AZD0486) plus rituximab, for people with follicular lymphoma (a type of slow-growing non-Hodgkin lymphoma) who haven't had treatment before. Surovatamig is an immunotherapy, meaning it helps your body's immune system fight cancer. We want to see if this new combination works better and is safer than standard treatments like R-CHOP, R-CVP, or BR. The study will first find the best dose of Surovatamig, then compare it to standard care. We'll be watching for side effects and how well the treatment works for up to 10 years. You might be able to join if you are at least 18 years old, have untreated follicular lymphoma, and meet other specific health criteria.
- Study design
- This is a global, randomized, open-label Phase III study with two parts, aiming to enroll 1018 participants. It compares Surovatamig plus rituximab to standard chemotherapy regimens.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety and treatment effectiveness for up to 10 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
At a glance
Conditions
Where it's being run
228 sites across 56 statesStudy leadership
- Chan Cheah, MBBS FRACP FRCPA DMSc · PRINCIPAL_INVESTIGATOR · Sir Charles Gairdner Hospital (SCGH)
Who to contact
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What this trial measures
- SRI Primary: Incidence, nature and severity of AEs and SAEs. Incidence and nature of study drug discontinuations, dose reductions, and dose delays due to AEsUp 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 chemoimmunotherapyUp 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 chemoimmunotherapyUp to 10 years
ORR at EoI, based on Lugano 2014 Response Criteria, as assessed by BICR.