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AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer
AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer
RecruitingPhase 3
Sponsor: AstraZeneca
Conditions: Epithelial Ovarian Cancer
Interventions: AZD5335, Mirvetuximab Soravtansine (MIRV), Paclitaxel, Pegylated liposomal Doxorubicin (PLD), Topotecan
Countries: United States, Australia, Belgium, Brazil, Canada, Chile, China, Czechia
The intention of the study is to demonstrate superiority of AZD5335 versus standard of care by assessment of progression-free survival (PFS) in women with high-grade, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, expressing high or low FRα levels.
Eligibility overview
Sex: FEMALE
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Key Inclusion criteria * Participants with confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer. * Participants must have platinum-resistant disease: * Participants who have only had one prior line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response (CR or PR) and then progressed between \> 3 months and ≤ 6 months after the date of the last dose of platinum. * Participants who have received 2 or 3 lines of platinum therapy must have progressed ≤ 6 months after the date of the last dose of platinum. * Participants must have radiologically progressed on or after their most recent line of therapy. * Participants must have received at least one, but no more than 3, prior systemic lines of anti-cancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment * Participants with documented BRCA mutation (germline and/or somatic) must have received prior PARPi if the participant is eligible per approved label and standard-of-care institutional guidelines, except in cases of documented contraindication, precaution or intolerance. * Provision of an FFPE tumour tissue sample Key Exclusion criteria * Participants with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumours containing any of the above histologies, or low-grade or borderline ovarian tumour. * Primary platinum-refractory disease, defined as disease that did not respond to or has progressed ≤ 3 months after the last dose of first line platinum-containing chemotherapy. * Participants with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring * Current signs, symptoms, or clinical investigations consistent with bowel obstruction, including sub-occlusive disease. * Participant has non-infectious ILD/pneumonitis or has a history of non-infectious ILD/pneumonitis that required oral or IV steroids or supplemental oxygen, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. * Prior treatment with any FRα-targeted therapy, including MIRV, or any TOP1i ADC. * Major surgical procedure within 4 weeks of the first dose of study intervention
Locations (299)
- Birmingham, Alabama, United States
- Little Rock, Arkansas, United States
- La Jolla, California, United States
- Washington D.C., District of Columbia, United States
- Fort Lauderdale, Florida, United States
- Gainesville, Florida, United States
- Jupiter, Florida, United States
- Miami, Florida, United States
- Weston, Florida, United States
- Chicago, Illinois, United States
- Evanston, Illinois, United States
- Peoria, Illinois, United States
- Urbana, Illinois, United States
- Fort Wayne, Indiana, United States
- Indianapolis, Indiana, United States
- Louisville, Kentucky, United States
- Towson, Maryland, United States
- Burlington, Massachusetts, United States
- Worcester, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Springfield, Missouri, United States
- Billings, Montana, United States
- Omaha, Nebraska, United States
- Las Vegas, Nevada, United States
- Lebanon, New Hampshire, United States
- Camden, New Jersey, United States
- The Bronx, New York, United States
- Chapel Hill, North Carolina, United States
- Blue Ash, Ohio, United States
- Dayton, Ohio, United States
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