At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- AZD5335 (drug), Mirvetuximab Soravtansine (MIRV) (drug), Paclitaxel (drug), Pegylated liposomal Doxorubicin (PLD) (drug)
- How long the study runs
- Study runs about 48 months (dates as stated)
- About the drug or intervention
- AZD5335 — drug: antibody drug conjugate · Mirvetuximab Soravtansine (MIRV) — drug: antibody drug conjugate · Paclitaxel — drug: chemotherapy · Pegylated liposomal Doxorubicin (PLD) — drug: chemotherapy · Topotecan — drug: chemotherapy
- Patient visit burden
- Not specified by the sponsor
In plain English
This AstraZeneca study looks at a drug called AZD5335 in people with epithelial ovarian cancer that has stopped responding to platinum chemotherapy. In people whose cancer has high levels of a protein called FRα, AZD5335 is compared with mirvetuximab soravtansine. In people whose cancer has low FRα levels, AZD5335 is compared with chemotherapy.
Who can take part
- Confirmed diagnosis of high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- Cancer is resistant to platinum chemotherapy (for example, the cancer came back or got worse within 6 months of the last platinum dose, with extra rules if you had only one course)
- Cancer has got worse on or after your most recent treatment, shown on a scan
- You have had at least 1 but no more than 3 previous courses of anti-cancer treatment, and single-drug treatment is suitable as your next option
- If you have a BRCA gene change, you must have already had a PARP inhibitor (a type of targeted drug) if you were suitable for it, unless there was a medical reason not to
- You can provide a stored tumour tissue sample
Who may not be able to
- Certain cancer types: endometrioid, clear cell, mucinous or sarcomatous; mixed tumours containing these; or low-grade or borderline ovarian tumours
- Cancer that never responded to the first platinum chemotherapy or got worse within 3 months of it
- Active or long-term cornea (front of the eye) problems, past cornea transplant, or eye conditions needing ongoing treatment or monitoring
- Current signs or tests suggesting a blocked bowel
- Non-infectious lung inflammation (ILD/pneumonitis), now or in the past needing steroid tablets or injections or extra oxygen, or if it cannot be ruled out on a scan
- Previous treatment targeting FRα, including mirvetuximab soravtansine, or any drug that delivers a TOP1 inhibitor (a chemotherapy-type drug) attached to an antibody
- Major surgery within 4 weeks of the first study dose
What taking part involves
- • Taking the study drug AZD5335, or the comparison treatment (mirvetuximab soravtansine or chemotherapy, depending on your FRα level) — details of how the drugs are given are not stated; ask the trial team
Time commitment: Not stated — ask the trial team about number of visits, how long the trial lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Female
- Number of participants
- 1,100
- Started
- 2025-12-29
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for epithelial ovarian cancer
- • Phase3 - 1,100 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with epithelial ovarian cancer
- • Female only
Where?
- • Barrow in Furness - Research Site
- • Birmingham - Research Site
- • Cambridge - Research Site
- • Canterbury - Research Site
- • +8 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Female only
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ platinum-resistant disease:
- ✓ of platinum-based therapy must have received at least 4 cycles of platinum
- ✓ progressed ≤ 6 months after the date of the last dose of platinum
- ✓ radiologically progressed on or after their most recent line of therapy
What the study is looking for
- ✓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 received 2 or 3 lines of platinum therapy must have progressed ≤ 6 months after the date of...
- ✓Participants must have radiologically progressed on or after their most recent line of therapy.
See the full criteria
Where Is This Study? (12 UK sites)
Research Site
Barrow in Furness LA14 4LF, United Kingdom
Research Site
Birmingham B152GW, United Kingdom
Research Site
Cambridge CB2 0QQ, United Kingdom
Research Site
Canterbury CT1 3NG, United Kingdom
Research Site
Cardiff CF15 7QZ, United Kingdom
Research Site
Edinburgh EH4 2XU, United Kingdom
Research Site
Greater London SW3 6JJ, United Kingdom
Research Site
London EC1A 7BE, United Kingdom
Research Site
London SE1 9RT, United Kingdom
Research Site
Nottingham NG5 1PB, United Kingdom
Research Site
Sutton SM2 5PT, United Kingdom
Research Site
Swansea SA12 7BR, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
