This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,097
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
The University of Arizona Cancer Center
Tucson, Arizona, United States
John Muir Clinical Research Center
Concord, California, United States
UCLA Women's Health Clinical Research Unit
Los Angeles, California, United States
Monotherapy Arm B and Arm D: Investigator Assessed Progression-free Survival (PFS)
PFS by investigator was defined as the time from randomization to disease progression, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
Time frame: From randomization until disease progression (up to the primary data analysis at approximately 39 months)
Monotherapy Arm B and Arm D: Investigator Assessed PFS
PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
Time frame: From randomization until disease progression (up to the primary data analysis at approximately 39 months)
Combination Therapy Arm A and Arm B: Investigator Assessed PFS
PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
Time frame: From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)
Monotherapy Arm B and Arm D: Blinded Independent Central Review (BICR) PFS
PFS was assessed by BICR per RECIST v1.1 as the time from randomization to disease progression, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
Time frame: From randomization until disease progression (up to the primary data analysis at approximately 39 months)
Monotherapy Arm B and Arm D: BICR PFS
PFS was assessed by BICR per RECIST v1.1 as the time from randomization to disease progression, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
Time frame: From randomization until disease progression (up to the primary data analysis at approximately 39 months)
Combination Therapy Arm A and Arm B: BICR PFS
PFS was assessed by BICR per RECIST v1.1 as the time from randomization to disease progression, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
Time frame: From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)
Monotherapy Arm B and Arm D: Overall Survival (OS)
OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause.
Time frame: From randomization until death due to any cause (up to the primary data analysis at approximately 36 months)
Monotherapy Arm B and Arm D: OS
OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause.
Time frame: From randomization until death due to any cause (up to the primary data analysis at approximately 40 months)
Combination Therapy Arm A and Arm B: OS
OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause.
Time frame: From randomization until death due to any cause (up to the combination therapy interim analysis at approximately 72 months)
Monotherapy Arm B and Arm D: Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) as assessed by the Investigator per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From randomization until disease progression (up to the primary data analysis at approximately 39 months)
Monotherapy Arm B and Arm D: ORR
ORR was defined as the percentage of participants with CR or PR as assessed by the Investigator per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From randomization until disease progression (up to the primary data analysis at approximately 39 months)
Combination Therapy Arm A and Arm B: ORR
ORR was defined as the percentage of participants with CR or PR as assessed by the Investigator per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)
Monotherapy Arm B and Arm D: Duration of Response (DOR)
DOR was assessed by the investigator and defined as the interval from the first documentation of objective response (CR or PR per RECIST v1.1) to the earlier of the first documentation of progressive disease (PD) or death from any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
Time frame: From first confirmed response until disease progression (up to the primary data analysis at approximately 30 months)
Monotherapy Arm B and Arm D: DOR
DOR was assessed by the investigator and defined as the interval from the first documentation of objective response (CR or PR per RECIST v1.1) to the earlier of the first documentation of PD or death from any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
Time frame: From first confirmed response until disease progression (up to the primary data analysis at approximately 33 months)
Combination Therapy Arm A and Arm B: DOR
DOR was assessed by the investigator and defined as the interval from the first documentation of objective response (CR or PR per RECIST v1.1) to the earlier of the first documentation of PD or death from any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
Time frame: From first confirmed response until disease progression (up to the combination therapy interim analysis at approximately 60 months)
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