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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,018
a fully human bispecific monoclonal IgG4 antibody
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
Rituximab, Cyclophosphamide, Vincristine and Prednisone
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
Safety Run in and Phase 3: ORR at EoI (Investigator assessed)
ORR defined as the proportion of participants achieving either a PR or CR at End of Induction based on Lugano 2014 Response Criteria
Time frame: Up to 10 years
Safety Run In and Phase 3: CR Rate
CR rate is defined as the proportion of participants achieving a CR at any time as based on Lugano 2014 Response Criteria
Time frame: Up to 10 years
AstraZeneca Clinical Study Information Center
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bendamustine, Rituximab
Research Site
Huntsville, Alabama, United States
RECRUITINGResearch Site
Anchorage, Alaska, United States
RECRUITINGResearch Site
Phoenix, Arizona, United States
NOT_YET_RECRUITINGResearch Site
Clovis, California, United States
NOT_YET_RECRUITINGResearch Site
Los Alamitos, California, United States
RECRUITINGResearch Site
San Diego, California, United States
NOT_YET_RECRUITINGResearch Site
Santa Monica, California, United States
NOT_YET_RECRUITINGResearch Site
Aurora, Colorado, United States
WITHDRAWNResearch Site
New Haven, Connecticut, United States
RECRUITINGResearch Site
Newark, Delaware, United States
NOT_YET_RECRUITING...and 225 more locations
Safety Run In and Phase 3: CR at EoI
Proportion of participants achieving CR at End of Induction based on Lugano 2014 Response Criteria
Time frame: Up to 10 years
Safety Run In and Phase 3: DoR
DoR will be defined from the time of first response until progression based on Lugano 2014 criteria, or death due to any cause
Time frame: up to 10 years
Safety Run In and Phase 3: PFS (Investigator assessed)
PFS (Investigator assessed) is defined as time from randomization until disease progression based on Lugano 2014 Response Criteria or death due to any cause
Time frame: Up to 10 years
Safety Run In and Phase 3: OS
OS is defined as time until the date of death
Time frame: Up to 10 years
Phase 3: CR rate at 30 months (CR30)
Proportion of participants in CR rate at 30 months (CR30) based on Lugano 2014 Response Criteria
Time frame: Up to 30 months
Phase 3: Time to First Subsequent Therapy or Death (TFST)
TFST will be defined as the time from randomization until the start date of first subsequent anti-lymphoma therapy or death due to any cause
Time frame: Up to 10 Years
Phase 3: Time from randomisation to second progression or death (PFS2)
PFS2 will be defined as the time from randomization until the earliest of the progression event, after first subsequent therapy, or death due to any cause
Time frame: Up to 10 Years