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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

NCT07218809

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
  • + 269 more on CT.gov