A Phase 3 Randomized Placebo-controlled Multicenter Study of Upifitamab Rilsodotin (UpRi) as Post-Platinum Maintenance Therapy for Participants with Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT).
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Ovarian Cancer
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Age: Between 18 years - 100 years
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Gender: Female
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Other Inclusion Criteria:
1. Participant must have a histological diagnosis of high grade serous ovarian cancer, which includes fallopian tube and primary peritoneal cancer, that is metastatic or recurrent. 2. Participant must have platinum-sensitive recurrent disease, defined as having achieved either a partial or complete response to 4 or more cycles in their penultimate platinum- containing regimen and their disease progressing more than 6 months after completion of the last dose of platinum containing therapy in the penultimate regimen. 3. Participant must have had 4 to 8 cycles of platinum-based chemotherapy in 2nd to 4th line setting in their most recent treatment regimen. 4. Participant must receive first study treatment infusion between 4 and 12 weeks after completing final dose of platinum in the most recent platinum-based regimen.
You may not be eligible for this study if the following are true:
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1. Participant has received prior treatment with mirvetuximab soravtansine or another ADC containing an auristatin or maytansinoid payload. 2. Participant has received bevacizumab in combination with last platinum-based regiment or plans to receive maintenance therapy outside the study intervention. 3. Participant has clinical signs or symptoms of gastrointestinal obstruction and/or requirement for parenteral hydration or nutrition. 4. Participant has ascites or pleural effusion managed with therapeutic paracentesis or thoracentesis within 28 days prior to signing the principal study consent form.
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.