The primary purpose of the study is to evaluate the efficacy of R-DXd with or without bevacizumab as maintenance therapy compared with standard of care (SOC) in participants with platinum-sensitive ovarian cancer (PSOC) as measured by progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
R-DXd will be administered as an intravenous (IV) infusion.
Bevacizumab will be administered as an IV infusion.
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
PFS is defined as the time (month) from the date of randomization to the earlier date of the first objective documentation of radiographic disease progression as assessed by BICR per RECIST v1.1 or death due to any cause.
Time frame: Up to approximately 6 years
Overall Survival (OS)
OS is defined as the time (month) from the date of randomization to the date of death due to any cause.
Time frame: Up to approximately 6 years
PFS as Assessed by Investigator per RECIST v1.1
PFS is defined as the time (month) from the date of randomization to the earlier date of the first objective documentation of radiological disease progression as assessed by the investigator per RECIST v1.1 or death due to any cause.
Time frame: Up to approximately 6 years
Progression Free Survival 2 (PFS2)
PFS2 is defined as the time (in months) from the date of randomization to the earlier date of the second disease progression, or death due to any cause.
Time frame: Up to approximately 6 years
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
TEAEs are defined as those adverse events (AEs) with a start or worsening date during the on-treatment period (from the first dose date to 70 days after the last dose date of study treatment).
Time frame: Up to approximately 6 years
Plasma Concentrations of R-DXd (Conjugated Antibody)
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Plasma Concentrations of Total Anti-Cadherin-6 (CDH6) Antibody
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Plasma Concentrations of DXd Payload
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Percentage of Participants Having Treatment-Emergent Antidrug Antibody (ADA)
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
CDH6 Protein Expression in Tumor Tissue as Determined by Immunochemistry Assay (Immunohistochemistry [IHC]) and Correlation with PFS and OS
Time frame: Up to approximately 6 years
Change From Baseline in Global Health Status/Quality of Life (QoL) Assessed by European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30 v3.0)
The EORTC QLQ-C30 assesses 5 functional scales, 3 symptom scales, a global health/QoL scale, and 6 single items. Change in QOLwill be assessed using 2 global health/QoL items scored on a 7-point scale ranging from 1 ("very poor") to 7 ("excellent"). Scores are linearly transformed on a scale 0 to 100. A high scale score represents a better QoL.
Time frame: Baseline up to approximately 6 years
Change From Baseline in Functional Sub-scales Scores Assessed by EORTC QLQ-C30 v3.0
The EORTC QLQ-C30 assesses 5 functional scales, 3 symptom scales, a global health/QoL scale, and 6 single items. The functional items are scored on a 4-point scale ranging from 1 ("not at all") to 4 ("very much"). Scores are linearly transformed on a scale 0 to 100. A high scale score represents a better functioning.
Time frame: Baseline up to approximately 6 years
Change From Baseline in Symptom Sub-scales Score Assessed by EORTC QLQ-C30 v3.0
The EORTC QLQ-C30 assesses 5 functional scales, 3 symptom scales, a global health/QoL scale, and 6 single items. The symptom items are scored on a 4-point scale ranging from 1 ("not at all") to 4 ("very much"). Scores are linearly transformed on a scale 0 to 100. A high scale score represents worst symptoms.
Time frame: Baseline up to approximately 6 years
Time to Deterioration (TTD) in Global Health Scale/QoL, Functioning and Symptoms as Measured by EORTC QLQ-C30 v3.0
The EORTC QLQ-C30 assesses 5 functional scales, 3 symptom scales, a global health/QoL scale, and 6 single items. The functional, symptom and single items are scored on a 4-point scale ranging from 1 ("not at all") to 4 ("very much"). The final 2 global health/QoL items are scored on a 7-point scale ranging from 1 ("very poor") to 7 ("excellent"). All of the scales and single-item measures scores are linearly transformed on a scale 0 to 100. A high scale score represents a higher response level and worst symptoms for the symptom scales.
Time frame: Up to approximately 6 years
Change From Baseline in Abdominal/Gastrointestinal (GI) Symptoms Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Ovarian Cancer Module (EORTC QLQ-OV28)
The EORTC QLQ-OV28 consists of 28 items assessing abdominal/GI symptoms (6 items), peripheral neuropathy (2 items), other chemotherapy side effects (5 items), hormonal symptoms (2 items), body image (2 items), attitudes to disease/treatment (3 items), sexuality (4 items), indigestion/heartburn (1 item), hair loss (2 items), and change in taste (1 item). All scores range from 0 to 100, with a higher score indicating a worse outcome, except for the sexuality domain, where this is reversed.
Time frame: Baseline up to approximately 6 years
Change From Baseline in Attitude to Disease/Treatment Assessed by EORTC QLQ-OV28
The EORTC QLQ-OV28 consists of 28 items assessing abdominal/GI symptoms (6 items), peripheral neuropathy (2 items), other chemotherapy side effects (5 items), hormonal symptoms (2 items), body image (2 items), attitudes to disease/treatment (3 items), sexuality (4 items), indigestion/heartburn (1 item), hair loss (2 items), and change in taste (1 item). All scores range from 0 to 100, with a higher score indicating a worse outcome, except for the sexuality domain, where this is reversed.
Time frame: Baseline up to approximately 6 years
TTD in Abdominal/GI Symptoms and Attitude to Disease/Treatment as Measured by EORTC QLQ-OV28
The EORTC QLQ-OV28 consists of 28 items assessing abdominal/GI symptoms (6 items), peripheral neuropathy (2 items), other chemotherapy side effects (5 items), hormonal symptoms (2 items), body image (2 items), attitudes to disease/treatment (3 items), sexuality (4 items), indigestion/heartburn (1 item), hair loss (2 items), and change in taste (1 item). All scores range from 0 to 100, with a higher score indicating a worse outcome, except for the sexuality domain, where this is reversed.
Time frame: Up to approximately 6 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.