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)
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.
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
Arms & interventions
- DrugSurovatamig
a fully human bispecific monoclonal IgG4 antibody
- DrugR-CHOP
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
- DrugR-CVP
Rituximab, Cyclophosphamide, Vincristine and Prednisone
- DrugBR
Bendamustine, Rituximab
Outcome measures
Primary
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
Frequency, severity, and relationship to study drug of AEs and SAEs; dose modifications; changes in physical examination and safety procedures.
Time frame: Up to 10 years
SRI Primary: Determination of the recommended Phase III dose (RP3D)
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
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
PFS, based on Lugano 2014 Response Criteria, as assessed by BICR.
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
ORR at EoI, based on Lugano 2014 Response Criteria, as assessed by BICR.
Time frame: Up to 10 years
Secondary
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
Study locations (51)
Research Site
Huntsville, Alabama, 35805
Research Site
Anchorage, Alaska, 99508
Research Site
Phoenix, Arizona, 85054
Research Site
Clovis, California, 93611
Research Site
Los Alamitos, California, 90720
Research Site
San Diego, California, 92121
Research Site
Santa Monica, California, 90404
Research Site
Aurora, Colorado, 80045
Research Site
New Haven, Connecticut, 06510
Research Site
Newark, Delaware, 19713
Research Site
Jacksonville, Florida, 32224
Research Site
Atlanta, Georgia, 30322
Research Site
Macon, Georgia, 31201
Research Site
Evanston, Illinois, 60201
Research Site
Peoria, Illinois, 61615
Research Site
Fort Wayne, Indiana, 46804
Research Site
Des Moines, Iowa, 50309
Research Site
Iowa City, Iowa, 52242
Research Site
Lexington, Kentucky, 40536
Research Site
Louisville, Kentucky, 40207
Research Site
Baton Rouge, Louisiana, 70808
Research Site
Baltimore, Maryland, 21201
Research Site
Bethesda, Maryland, 20817
Research Site
Columbia, Maryland, 21044
Research Site
Boston, Massachusetts, 02114
Research Site
Boston, Massachusetts, 02215
Research Site
Ann Arbor, Michigan, 48109
Research Site
Detroit, Michigan, 48201
Research Site
Ypsilanti, Michigan, 48197
Research Site
Saint Paul, Minnesota, 55102
Research Site
Springfield, Missouri, 65807
Research Site
Hackensack, New Jersey, 07601
Research Site
New Brunswick, New Jersey, 08901
Research Site
New Hyde Park, New York, 11042
Research Site
New York, New York, 10016
Research Site
New York, New York, 10032
Research Site
New York, New York, 10065
Research Site
Charlotte, North Carolina, 28204
Research Site
Winston-Salem, North Carolina, 27103
Research Site
Blue Ash, Ohio, 45242
Research Site
Columbus, Ohio, 43210
Research Site
Eugene, Oregon, 97401
Research Site
Pittsburgh, Pennsylvania, 15232
Research Site
Nashville, Tennessee, 37203
Research Site
Shenandoah, Texas, 77380
Research Site
Tyler, Texas, 75702
Research Site
Salt Lake City, Utah, 84112
Research Site
Fairfax, Virginia, 22031
Research Site
Richmond, Virginia, 23219
Research Site
Tacoma, Washington, 98405
Research Site
Madison, Wisconsin, 53792