Recruiting NCT06549595

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

Phase III Interventional Untreated Follicular Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Surovatamig, R-CHOP, R-CVP, BR.
Who it may be relevant to: Registry conditions: Untreated Follicular Lymphoma. Basic parameters: 18 years — 130 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Belgium, Brazil, Canada +18
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase III, Multicentre, Randomised, Open-label Study to Compare the Efficacy and Safety of AZD0486 Plus Rituximab Versus Chemotherapy Plus Rituximab in Previously Untreated Participants With Follicular Lymphoma (SOUNDTRACK-F1)

Overview

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.

Detailed description

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

Interventions

Drug Surovatamig
a fully human bispecific monoclonal IgG4 antibody
Drug R-CHOP
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
Drug R-CVP
Rituximab, Cyclophosphamide, Vincristine and Prednisone
Drug BR
Bendamustine, Rituximab

Primary outcome 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 AEs [Time frame: Up to 10 years]
SRI Primary: Determination of the recommended Phase III dose (RP3D) [Time frame: Up to 1 year]
Phase 3 Dual Primary: To demonstrate the superiority of Surovatamig plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy [Time frame: Up to 10 years]
Phase 3 Dual Primary: To demonstrate the superiority of Surovatamig plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy [Time frame: Up to 10 years]

Secondary outcome measures (9)

Safety Run in and Phase 3: ORR at EoI (Investigator assessed) [Time frame: Up to 10 years]
Safety Run In and Phase 3: CR Rate [Time frame: Up to 10 years]
Safety Run In and Phase 3: CR at EoI [Time frame: Up to 10 years]
Safety Run In and Phase 3: DoR [Time frame: up to 10 years]
Safety Run In and Phase 3: PFS (Investigator assessed) [Time frame: Up to 10 years]
Safety Run In and Phase 3: OS [Time frame: Up to 10 years]
Phase 3: CR rate at 30 months (CR30) [Time frame: Up to 30 months]
Phase 3: Time to First Subsequent Therapy or Death (TFST) [Time frame: Up to 10 Years]
Phase 3: Time from randomisation to second progression or death (PFS2) [Time frame: Up to 10 Years]

Eligibility criteria

Inclusion criteria

Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.
Histologically confirmed diagnosis of classic FL per WHO 2022 classification
ECOG performance status of 0 to 2
No prior systemic lymphoma-directed therapy
Need for systemic treatment meeting at least 1 GELF criteria
FDG-avid and measurable disease
Stage II to IV and FLIPI 2-5 \[Phase III only\]
Adequate liver, hematological, renal and cardiac function.

The above is a summary, other inclusion criteria details may apply

Exclusion criteria

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
Contra-indication to BR, RCVP, and R-CHOP
Participants with or history of CNS lymphoma
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
Presence of >5000 circulating lymphoma cells
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
Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)

The above is a summary, other exclusion criteria details may apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 55 centers

Research Site — Huntsville
Research Site — Anchorage
Research Site — Phoenix
Research Site — Clovis
Research Site — Los Alamitos
Research Site — San Diego
Research Site — Santa Monica
Research Site — Aurora
… and 47 more centers

China · 34 centers

Research Site — Beijing
Research Site — Beijing
… and 32 more centers

Japan · 19 centers