This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) in combination with bevacizumab works in treating platinum-sensitive ovarian cancer compared to standard treatments by checking whether it makes cancers smaller or disappear completely and if it helps participants live longer. The study also assesses whether Mo-Rez in combination with bevacizumab is safe and tolerated well by participants compared to standard treatments and aims to provide a better understanding of the main side effects of Mo-Rez.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
690
Mocertatug rezetecan will be administered
Carboplatin will be administered
Paclitaxel will be administered
Gemcitabine will be administered
PLD will be administered
Bevacizumab will be administered
GSK Investigational Site
Hokkaido, Japan
Progression Free Survival (PFS) by BICR
PFS is defined as the time from the date of randomization to the date of first documented disease progression (PD) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by Blinded independent central review (BICR) assessment or death from any cause, whichever occurs first.
Time frame: Up to approximately 191 weeks
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
Time frame: Up to approximately 343 weeks
PFS by investigator assessment
PFS is defined as the time from the date of randomization to the date of first documented PD per RECIST 1.1 by investigator assessment or death from any cause, whichever occurs first.
Time frame: Up to approximately 343 weeks
Time to Second Progression (PFS2)
PFS2 is defined as the time from the date of randomization to the date of first documented investigator-assessed clinical or radiographical progression following the first subsequent anticancer therapy and after the progression event used for the primary variable PFS, or death from any cause, whichever occurs first.
Time frame: Up to approximately 343 weeks
Objective response rate (ORR) by investigator assessment
ORR is defined as the percentage of participants with a complete response (CR) or partial response (PR) per RECIST 1.1 by investigator assessment.
Time frame: Up to approximately 343 weeks
Duration of Response (DOR) by investigator assessment
DOR is defined as the time from the date of first documented objective response (CR or PR) per RECIST 1.1 by investigator assessment to the date of first documented PD per RECIST 1.1 by investigator assessment or death due to any cause, whichever occurs first.
Time frame: Up to approximately 343 weeks
ORR by BICR
ORR is defined as the percentage of participants with a CR or PR per RECIST 1.1 by BICR.
Time frame: Up to approximately 343 weeks
DOR by BICR
DOR is defined as the time from the date of first documented objective response (CR or PR) per RECIST 1.1 by BICR assessment to the date of first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first.
Time frame: Up to approximately 343 weeks
Time to first subsequent therapy (TFST)
TFST is defined as the time from the date of randomization to the date of initiation of subsequent therapy or death from any cause, whichever occurs first.
Time frame: Up to approximately 343 weeks
Time to second subsequent therapy (TSST)
TSST is defined as the time from the date of randomization to the date of initiation of second subsequent therapy or death from any cause, whichever occurs first.
Time frame: Up to approximately 343 weeks
Number of participants with Treatment-emergent adverse event (TEAEs), Adverse event of special interest (AESIs) and Treatment-emergent serious adverse event (TESAEs)
Time frame: Up to approximately 343 weeks
Number of participants with TEAEs leading to dose modifications or study intervention discontinuation
Time frame: Up to approximately 343 weeks
Number of participants with changes in vital signs, laboratory tests (hematology and clinical chemistry), and Electrocardiogram (ECG)
Time frame: Up to approximately 343 weeks
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score
The EORTC QLQ-C30 includes 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. The following domains will be measured: Global health status (GHS)/ Quality of Life (QoL), physical functioning, role functioning. Participants responses on these items are averaged and then transformed to scores, ranging from 0 to 100. Higher score indicates better functioning or a better . overall state of health.
Time frame: Up to approximately 343 weeks
Change from baseline in EORTC QLQ-Ovarian Cancer Module (OV28) score
The EORTC QLQ-OV28 includes a 28-item questionnaire for evaluating ovarian cancer-specific symptoms and concerns in participants of cancer clinical studies. These include items that assess symptoms in the abdominal/gastrointestinal domain. Scores are averaged and transformed to a 0 to 100 scale; higher scores indicate a greater symptom burden, while lower scores reflect fewer symptoms.
Time frame: Up to approximately 343 weeks
Time to deterioration (TTD) of EORTC QLQ-C30
TTD is defined as the time from the date of randomization to the first confirmed clinically meaningful deterioration on any of the following EORTC QLQ-C30 domains: physical functioning, role functioning and Global Health Status (GHS)/ Quality of Life (QoL).
Time frame: Up to approximately 343 weeks
Time to deterioration (TTD) of EORTC QLQ-OV28
TTD is defined as the time from the date of randomization to the first confirmed clinically meaningful deterioration on the abdominal /gastrointestinal symptom domain of the EORTC QLQ-OV28.
Time frame: Up to approximately 343 weeks
Serum concentration of Mo-Rez
Time frame: Up to approximately 343 weeks
Number of participants with Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Mo-Rez
Time frame: Up to approximately 343 weeks
Titers of ADA against Mo-Rez
Time frame: Up to approximately 343 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.