Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase3

A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients

Sponsor: AstraZeneca

NCT ID: NCT06549595

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Surovatamig (drug), R-CHOP (drug), R-CVP (drug), BR (drug)
How long the study runs
Study runs about 87 months (dates as stated)
About the drug or intervention
Surovatamig — drug: a fully human bispecific monoclonal IgG4 antibody · R-CHOP — drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone · R-CVP — drug: Rituximab, Cyclophosphamide, Vincristine and Prednisone · BR — drug: Bendamustine, Rituximab
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 130 Years
Who
All
Number of participants
1,018
Started
2024-08-07
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for untreated follicular lymphoma
  • • Phase3 - 1,018 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 130 Years
  • • Diagnosed with untreated follicular lymphoma

Where?

  • • London - Research Site
  • • London - Research Site
  • • Newcastle upon Tyne - Research Site
  • • Norwich - Research Site
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

The study consists of 2 sequential parts. 1. Safety Run-in - this part will compare dose levels of Surovatamig (AZD0486) in combination with rituximab in order to establish the RP3D. 2. Phase III - The Phase III part will assess the superiority of Surovatamig (AZD0486) at RP3D in combination with rituximab, compared to Investigator's choice between 3 standard chemoimmunotherapy regimens. Phase 3 consists of 3 arms 1. Arm A: treatment with Surovatamig plus rituximab Schedule A 2. Arm B: treatment with Surovatamig plus rituximab Schedule B 3. Arm C (Comparator arm): one of the following standard regimens per Investigator's choice: R-CVP + rituximab maintenance, R-CHOP + rituximab maintenance or B-R + rituximab maintenance

Untreated Follicular Lymphoma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 130 Years
  • Who can join: All genders
  • How fit you need to be: ECOG 0 or better

Biomarkers mentioned

consecutive negative

What the study is looking for

  • ✓Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.
  • ✓confirmed by a biopsy diagnosis of classic FL per WHO 2022 classification
  • ✓Fit enough for normal activity (ECOG 0) to 2
  • ✓No prior systemic lymphoma-directed therapy
  • ✓Need for systemic treatment meeting at least 1 GELF criteria

Who cannot take part

  • ✗Follicular large B-cell lymphoma (WHO 2022 classification), formerly Follicular lymphoma Grade 3B (WHO 2016...
  • ✗Contra-indication to BR, RCVP, and R-CHOP
  • ✗Participants with or history of CNS lymphoma
  • ✗Presence of \>5000 circulating lymphoma cells
  • ✗Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)
See the full criteria
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

Where Is This Study? (7 UK sites)

Research Site

London EC1M6BQ, United Kingdom

Recruiting

Research Site

London SE5 9RS, United Kingdom

Recruiting

Research Site

Newcastle upon Tyne NE7 7DN, United Kingdom

Recruiting

Research Site

Norwich NR4 7UY, United Kingdom

Recruiting

Research Site

Nottingham NG5 1PB, United Kingdom

Recruiting

Research Site

Plymouth PL6 8DH, United Kingdom

Recruiting

Research Site

Southampton SO16 6YD, United Kingdom

WITHDRAWN

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09