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AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer (TREVI-OC-01)
EU CTIS ID: 2025-520466-22-00
What this study is testing
For the high FRα Cohort: To determine the efficacy of AZD5335 as compared to Mirvetuximab Soravtansine (MIRV) in participants with Platinum-resistant relapsed ovarian cancer (PRR OC) whose tumours have FRα-high expression by assessment of progression-free survival (PFS). For the low FRα Cohort: To determine the efficacy of AZD5335 as compared to Investigator’s choice chemotherapy in participants with PRR OC whose tumours have FRα-low expression by assessment of PFS.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Participants with confirmed diagnosis of high-grade serous EOC, primaryperitoneal cancer, or fallopian tube cancer.
- 2. Participants must have platinum-resistant disease: a) 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. b) 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.
- 3. Participants must have radiologically progressed on or after their most recent line of therapy.
- 4. 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
- 5. 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
- 6. Provision of an FFPE tumour tissue sample
You likely can't join if
- 1. Participants with endometrioid, clear cell, mucinous, or sarcomatous histology,mixed tumours containing any of the above histologies, or low-grade or borderline ovarian tumour.
- 2. 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-containingchemotherapy.
- 3. Participants with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring
- 4. Current signs, symptoms, or clinical investigations consistent with bowel obstruction, including sub-occlusive disease.
- 5. 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.
- 6. Prior treatment with any FRα-targeted therapy, including MIRV, or any TOP1i ADC.
See the full eligibility criteria
- 1. Participants with confirmed diagnosis of high-grade serous EOC, primaryperitoneal cancer, or fallopian tube cancer.
- 2. Participants must have platinum-resistant disease: a) 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. b) 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.
- 3. Participants must have radiologically progressed on or after their most recent line of therapy.
- 4. 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
- 5. 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
- 6. Provision of an FFPE tumour tissue sample
- 1. Participants with endometrioid, clear cell, mucinous, or sarcomatous histology,mixed tumours containing any of the above histologies, or low-grade or borderline ovarian tumour.
- 2. 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-containingchemotherapy.
- 3. Participants with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring
- 4. Current signs, symptoms, or clinical investigations consistent with bowel obstruction, including sub-occlusive disease.
- 5. 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.
- 6. Prior treatment with any FRα-targeted therapy, including MIRV, or any TOP1i ADC.
- 7. Major surgical procedure within 4 weeks of the first dose of study intervention
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- Chile
- India
- China
- Taiwan
- Israel
- United States
- Thailand
- Switzerland
- Korea, Republic of
- Canada
- Japan
- Australia
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; Chile; India; China; Taiwan; Israel and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.