A Phase 3, Open-label, Multicenter, Randomized Trial of Trastuzumab Deruxtecan with Bevacizumab Verus Bevacizumab Monotherapy as First-line Maintenance Therapy in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01/ENGOT-ov89/GEICO144-O/GOG-3112)

Conditions

Ovarian Cancer

Brief summary

Progression Free Survival by Blinded Independent Central Review (BICR) in the HER2 IHC 3+/2+ population Time from randomization to time of objective radiographic disease progression as assessed by BICR based on RECIST v1.1 or death due to any cause.

Detailed description

Overall Survival in the HER2 IHC 3+/2+ population Time interval from the date of randomization to the date of death due to any cause., Progression Free Survival by BICR in the HER2 IHC 3+/2+/1+ population. Time from randomization to time of objective radiographic disease progression as assessed by BICR based on RECIST v1.1 or death due to any cause., Overall Survival in the HER2 IHC 3+/2+/1+ population Time interval from the date of randomization to the date of death due to any cause., Progression Free Survival by the investigator in HER2 IHC 3+/2+ population Time from randomization to time of objective radiographic disease progression as assessed by the investigator based on RECIST v1.1 or death due to any cause., Progression Free Survival by the investigator in HER2 IHC 3+/2+/1+ population Time from randomization to time of objective radiographic disease progression as assessed by the investigator based on RECIST v1.1 or death due to any cause.

Related papers

No related papers found yet.

Interventions

DRUGVEGZELMA 25 mg/mL concentrate for solution for infusion

DRUGDS-8201a

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression Free Survival by Blinded Independent Central Review (BICR) in the HER2 IHC 3+/2+ population Time from randomization to time of objective radiographic disease progression as assessed by BICR based on RECIST v1.1 or death due to any cause.	—

Secondary

Measure	Time frame
Overall Survival in the HER2 IHC 3+/2+ population Time interval from the date of randomization to the date of death due to any cause., Progression Free Survival by BICR in the HER2 IHC 3+/2+/1+ population. Time from randomization to time of objective radiographic disease progression as assessed by BICR based on RECIST v1.1 or death due to any cause., Overall Survival in the HER2 IHC 3+/2+/1+ population Time interval from the date of randomization to the date of death due to any cause., Progression Free Survival by the investigator in HER2 IHC 3+/2+ population Time from randomization to time of objective radiographic disease progression as assessed by the investigator based on RECIST v1.1 or death due to any cause., Progression Free Survival by the investigator in HER2 IHC 3+/2+/1+ population Time from randomization to time of objective radiographic disease progression as assessed by the investigator based on RECIST v1.1 or death due to any cause.	—

Measure

Time frame

Overall Survival in the HER2 IHC 3+/2+ population Time interval from the date of randomization to the date of death due to any cause., Progression Free Survival by BICR in the HER2 IHC 3+/2+/1+ population. Time from randomization to time of objective radiographic disease progression as assessed by BICR based on RECIST v1.1 or death due to any cause., Overall Survival in the HER2 IHC 3+/2+/1+ population Time interval from the date of randomization to the date of death due to any cause., Progression Free Survival by the investigator in HER2 IHC 3+/2+ population Time from randomization to time of objective radiographic disease progression as assessed by the investigator based on RECIST v1.1 or death due to any cause., Progression Free Survival by the investigator in HER2 IHC 3+/2+/1+ population Time from randomization to time of objective radiographic disease progression as assessed by the investigator based on RECIST v1.1 or death due to any cause.

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Countries

Austria, Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Poland, Romania, Spain, Sweden

Outcome results

None listed