AZD5335 versus mirvetuximab or chemotherapy for FRα-high and FRα-low platinum-resistant ovarian, fallopian tube, or peritoneal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

About 1,100 adults with high-grade, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer will be centrally tested for folate receptor alpha (FRα) and placed into two cohorts (approximately 550 FRα-high and 550 FRα-low). Within each cohort participants are randomized 1:1 to receive AZD5335 or the relevant standard of care (mirvetuximab soravtansine in the FRα-high cohort; investigator-choice single-agent chemotherapy in the FRα-low cohort). Participants remain on assigned treatment with tumor assessments per RECIST v1.1 until progression or discontinuation, and all are followed for overall survival. An independent data monitoring committee will periodically review unblinded safety and interim efficacy data to protect participants and study integrity.

Why it matters

Who can join: the full rules

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

Where it's running

• Research Site
  Birmingham, Alabama, United States Recruiting
• Research Site
  Washington D.C., District of Columbia, United States Recruiting
• Research Site
  Gainesville, Florida, United States Recruiting
• Research Site
  Jupiter, Florida, United States Recruiting
• Research Site
  Miami, Florida, United States Recruiting
• Research Site
  Peoria, Illinois, United States Recruiting

+249 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining carboplatin with mirvetuximab soravtansine before surgery for FRα-positive advanced serous ovarian, fallopian tube, or primary peritoneal cancer

  This will test whether giving mirvetuximab soravtansine with carboplatin before surgery helps people with newly diagnosed FRα-positive advanced-stage serous ovarian, fallopian tube, or primary peritoneal cancer.

  Recruiting at 71 sites Phase 2 AbbVie · Birmingham, Alabama and 72 other locations · NCT06890338

• VT-101 in Advanced Ovarian Cancer: early safety study in adults

  This early-phase trial tests VT-101 in adult women with advanced, recurrent, or relapsed epithelial ovarian cancer to see if it is safe, how the body handles it, and whether there are any initial signs of activity.

  Recruiting Phase 1 University of Iowa · Iowa City, Iowa · NCT07905677

• Real-world use of mirvetuximab soravtansine in FRα-positive platinum-resistant ovarian, fallopian tube, and peritoneal cancer

  This study tests how mirvetuximab soravtansine works in real-world adults with FRα-positive platinum-resistant ovarian, fallopian tube, or peritoneal cancer.

  Recruiting AbbVie · Vienna · NCT07896421

• Torvutatug samrotecan plus bevacizumab as first-line maintenance in non-HRD advanced epithelial ovarian cancer

  This trial tests whether adding torvu-samrotecan to bevacizumab after standard chemotherapy helps people with non-HRD advanced epithelial ovarian cancer live longer without the cancer worsening compared with bevacizumab alone.

  Recruiting at 4 sites Phase 3 AstraZeneca · Tamarac, Florida and 219 other locations · NCT07851025

• Whole-body metabolic activity as a predictor of chemotherapy response in epithelial ovarian cancer

  This study tests whether whole-body metabolic activity can predict how well epithelial ovarian cancer responds to chemotherapy.

  Recruiting University of Tennessee Graduate School of Medicine · Knoxville, Tennessee · NCT07764133

• [68Ga]BED003 PET imaging to see fibroblast activity in selected cancers

  This study tests a PET imaging agent, [68Ga]BED003, to see how well it detects tumors in colorectal, gastric, pancreatic, ovarian, and invasive lobular breast cancers.

  Recruiting at 5 sites Phase 2 Blue Earth Diagnostics · Bergamo, Lombardy and 5 other locations · NCT07702292

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.