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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
AZD5335 in FRa-high cohort 		AZD5335 IV (intravenous) in FRa-high cohort
  • Drug: AZD5335
    antibody drug conjugate
Active Comparator
Mirvetuximab Soravtansine (MIRV) in FRa-high cohort 		MIRV AIBW IV in FRa-high cohort
  • Drug: Mirvetuximab Soravtansine (MIRV)
    antibody drug conjugate
    Other names:
    • Elahere
Experimental
AZD5335 in FRa-low cohort 		AZD5335 IV (intravenous) in FRa-low cohort
  • Drug: AZD5335
    antibody drug conjugate
Active Comparator
Investigator´s choice chemotherapy in FRa-low cohort 		Investigator's choice of chemotherapy Paclitaxel IV Pegylated liposomal Doxorubicin (PLD) IV or Topotecan IV in FRa-low cohor
  • Drug: Paclitaxel
    chemotherapy
    Other names:
    • Taxol; Onxol
  • Drug: Pegylated liposomal Doxorubicin (PLD)
    chemotherapy
    Other names:
    • Doxil; Caelyx
  • Drug: Topotecan
    chemotherapy
    Other names:
    • Hycamtin

Recruiting Locations

Research Site
Birmingham, Alabama 35223

Research Site
Washington D.C., District of Columbia 20010

Research Site
Gainesville, Florida 32608

Research Site
Jupiter, Florida 33458

Research Site
Miami, Florida 33176

Research Site
Peoria, Illinois 61637

Research Site
Urbana, Illinois 61801

Research Site
Fort Wayne, Indiana 46845

Research Site
Indianapolis, Indiana 46202

Research Site
Louisville, Kentucky 40241

Research Site
Towson, Maryland 21204

Research Site
Burlington, Massachusetts 01805

Research Site
Minneapolis, Minnesota 55404

Research Site
Springfield, Missouri 65807

Research Site
Billings, Montana 59106

Research Site
Omaha, Nebraska 68114

Research Site
Las Vegas, Nevada 89106

Research Site
Chapel Hill, North Carolina 27599

Research Site
Blue Ash, Ohio 45242

Research Site
Dayton, Ohio 45459

Research Site
Portland, Oregon 97213

Research Site
Germantown, Tennessee 38138

Research Site
San Antonio, Texas 78229

Research Site
Tyler, Texas 75702

Research Site
Fairfax, Virginia 22031

Research Site
Roanoke, Virginia 24016

Research Site
Seattle, Washington 98104

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Detailed Description

Approximately 1100 adult participants will be enrolled after central FRα testing into two independent cohorts (about 550 FRα-high and 550 FRα-low) and randomized 1:1 within each cohort to receive AZD5335 or the relevant standard of care (mirvetuximab soravtansine in FRα-high; investigator's choice single-agent chemotherapy in FRα-low). Participants will remain on assigned treatment and undergo regular tumor evaluations per RECIST v1.1 until disease progression or another reason for treatment discontinuation. All participants will be followed for overall survival. An independent data monitoring committee (IDMC) of external experts will periodically review unblinded safety and interim efficacy to confirm participant safety and study integrity.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.