GOG 3096: Dose Optimization and Phase 3 Study of R-DXd versus Investigators Choice of Chemotherapy in Platinum-resistant Ovarian Cancer
Brief description of study
Phase 2: To evaluate BICR-assessed objective response rate at each dose level of R-DXd.
Phase 3:To evaluate BICR-assessed objective response rate with R-DXd treatment compared with investigator's choice of paclitaxel, PLD, gemcitabine, or topotecan.
Objectives, outcome measures, and endpoints are located in Tables 3.1 and 3.2 of the protocol. Phase 2: The primary outcome measure is objective response rate as assessed by BICR based on RECIST version 1.1. This will be assessed at the time of interim and primary dose-optimization analysis.
Phase 3: The primary outcome measure is objective response rate as assessed by BICR based on RECIST version 1.1 for R-DXd treatment compared with investigator's choice of standard of care chemotherapy. This will be assessed at the time of interim and primary dose-optimization analysis.
Objectives, outcome measures, and endpoints are located in Tables 3.1 and 3.2 of the protocol. Phase 2: The secondary outcome measure is objective response rate as assessed by the investigator based on RECIST version 1.1. This will be assessed at the time of interim and primary dose-optimization analysis.
Phase 3: The secondary outcome measure is overall survival time from randomization.
Objectives, outcome measures, and endpoints are located in Tables 3.1 and 3.2 of the protocol.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
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Age: - 99 Years
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Gender: All
TBD
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