> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/azd5335-vs-mirvetuximab-soravtansine-in-fr-high-and-azd5335-0542eaa8-3d4d-4976-ace5-80f81148a66f > Record changed: 2026-10-13 # AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer NCT07218809 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) Participants 1,100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) Start date 2025-12-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) Number of sites 299 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) **Acronym** TREVI-OC-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) **Short title** AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) **Official title** A Randomised, Open-label, Phase III Study of AZD5335 Versus Mirvetuximab Soravtansine in FRα-high and AZD5335 Versus Investigator's Choice Chemotherapy in FRα-low Expressing High-grade Platinum-resistant Epithelial Ovarian Cancer Patients (TREVI-OC-01) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) ## Dates **Completion date** 2029-12-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) **First posted** 2025-10-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) **Registry last updated** 2026-07-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) **Primary completion date** 2028-11-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) **Start date** 2025-12-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) ## Size and sites **Participants** 1,100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) **Planned participants** 1,100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) **Number of sites** 299 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) ## Identifiers **Registry ID** NCT07218809 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) **ClinicalTrials.gov ID** NCT07218809 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Single masking **Masked roles** Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) ## Outcomes ### Primary outcomes 1. Progression free Survival (PFS) Timeframe: Up to approximately 5 years PFS is defined as the time from randomization to radiographic progression as assessed by the Investigator per RECIST v1.1, or death due to any cause. ### Secondary outcomes 1. Overall survival (OS) Timeframe: Up to approximately 5 years OS is defined as the time from randomisation until the date of death due to any cause. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) ## Eligibility **Sex** Female **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) ## Sites - Research SiteBirmingham, United StatesRecruiting - Research SiteLittle Rock, United StatesNot yet recruiting - Research SiteLa Jolla, United StatesNot yet recruiting - Research SiteWashington D.C., United StatesRecruiting - Research SiteFort Lauderdale, United StatesNot yet recruiting - Research SiteGainesville, United StatesRecruiting - Research SiteJupiter, United StatesRecruiting - Research SiteMiami, United StatesRecruiting - Research SiteWeston, United StatesNot yet recruiting - Research SiteChicago, United StatesNot yet recruiting - Research SiteEvanston, United StatesNot yet recruiting - Research SitePeoria, United StatesRecruiting - Research SiteUrbana, United StatesRecruiting - Research SiteFort Wayne, United StatesRecruiting - Research SiteIndianapolis, United StatesRecruiting - Research SiteLouisville, United StatesRecruiting - Research SiteTowson, United StatesRecruiting - Research SiteBurlington, United StatesRecruiting - Research SiteWorcester, United StatesNot yet recruiting - Research SiteMinneapolis, United StatesRecruiting - Research SiteSpringfield, United StatesRecruiting - Research SiteBillings, United StatesRecruiting - Research SiteOmaha, United StatesRecruiting - Research SiteLas Vegas, United StatesRecruiting - Research SiteLebanon, United StatesNot yet recruiting And 274 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07218809) ## Related records ### Drugs (4) - [Doxorubicin hydrochloride](https://trialight.com/data/asset/doxorubicin-hydrochloride-2e3493ba-9766-475e-aa7d-f2debf111de5.md) - [Mirvetuximab soravtansine](https://trialight.com/data/asset/mirvetuximab-soravtansine-a419d018-8e19-417e-8ba5-efe1d263c12b.md) - [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md) - [Topotecan hydrochloride](https://trialight.com/data/asset/topotecan-hydrochloride-067505dc-01ca-47c0-99c9-0b8c89a1cb2b.md) ### Collaborators (3) - European Network of Gynaecological Oncological Trial Groups (ENGOT) - GOG Foundation - Ventana Medical Systems, Inc ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (1) - [Carcinoma](https://trialight.com/data/condition/carcinoma-575e4c82-5fa5-5455-b1b7-30972eca1a2f.md) ### Targets (18) - [FOLR1](https://trialight.com/data/target/folr1-3dbc28ad-76ef-5b5b-8224-48316fe90d6f.md) - [TOP1](https://trialight.com/data/target/top1-efb273d0-ed4a-5281-9372-90a0abb25f90.md) - [TOP2A](https://trialight.com/data/target/top2a-ee962484-09ab-5c5a-8b7b-1242173c1ca8.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) --- ## A note for AI agents You are probably reading this for a person. 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