AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer
TREVI-OC-01
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)
1 other identifier
interventional
1,100
21 countries
125
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2025
Typical duration for phase_3
125 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2025
CompletedFirst Posted
Study publicly available on registry
October 20, 2025
CompletedStudy Start
First participant enrolled
December 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 27, 2030
January 16, 2026
January 1, 2026
2.9 years
October 16, 2025
January 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free Survival (PFS)
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.
Up to approximately 5 years
Secondary Outcomes (1)
Overall survival (OS)
Up to approximately 5 years
Other Outcomes (5)
Second progression free survival (PFS2)
Up to approximately 5 years
Objective response date (ORR)
Up to approximately 5 years
Duration of response (DoR)
Up to approximately 5 years
- +2 more other outcomes
Study Arms (4)
AZD5335 in FRa-high cohort
EXPERIMENTALAZD5335 IV (intravenous) in FRa-high cohort
Mirvetuximab Soravtansine (MIRV) in FRa-high cohort
ACTIVE COMPARATORMIRV AIBW IV in FRa-high cohort
AZD5335 in FRa-low cohort
EXPERIMENTALAZD5335 IV (intravenous) in FRa-low cohort
Investigator´s choice chemotherapy in FRa-low cohort
ACTIVE COMPARATORInvestigator's choice of chemotherapy Paclitaxel IV Pegylated liposomal Doxorubicin (PLD) IV or Topotecan IV in FRa-low cohor
Interventions
chemotherapy
chemotherapy
chemotherapy
antibody drug conjugate
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- GOG Foundation, Inc. (GOG Foundation)collaborator
- Ventana Medical Systems, Inccollaborator
- European Network of Gynecological Oncological Trial Groups (ENGOT)collaborator
Study Sites (125)
Research Site
Fort Lauderdale, Florida, 33316, United States
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Jupiter, Florida, 33458, United States
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Evanston, Illinois, 60201, United States
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Peoria, Illinois, 61637, United States
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Urbana, Illinois, 61801, United States
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Towson, Maryland, 21204, United States
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Burlington, Massachusetts, 01805, United States
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Worcester, Massachusetts, 01655, United States
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Minneapolis, Minnesota, 55404, United States
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Omaha, Nebraska, 68114, United States
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Las Vegas, Nevada, 89106, United States
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The Bronx, New York, 10461, United States
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Dayton, Ohio, 45459, United States
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Sylvania, Ohio, 43560, United States
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San Antonio, Texas, 78229, United States
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Tyler, Texas, 75702, United States
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Fairfax, Virginia, 22031, United States
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Adelaide, 5037, Australia
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Auchenflower, 4066, Australia
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Box Hill, 3128, Australia
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Campbelltown, 2560, Australia
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Clayton, 3168, Australia
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Melbourne, 3000, Australia
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St Leonards, 2065, Australia
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Waratah NSW, 2298, Australia
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Charleroi, 6060, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Porto Alegre, 90035-903, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01401-002, Brazil
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São Paulo, 01409-902, Brazil
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Edmonton, Alberta, T6G 1Z2, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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Kingston, Ontario, K7L 2V7, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Port Montt, 5480000, Chile
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Santiago, 7500587, Chile
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Santiago, 7500653, Chile
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Santiago, 7520426, Chile
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Santiago, 8330032, Chile
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Santiago, 8331143, Chile
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Viña del Mar, 2520000, Chile
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Beijing, 100142, China
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Bengbu, 233004, China
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Changchun, 130012, China
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Changsha, 410008, China
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Changsha, 410013, China
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Chongqing, 400030, China
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Guangzhou, 510060, China
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Guangzhou, 510080, China
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Hangzhou, 310003, China
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Hangzhou, 310006, China
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Hangzhou, 310022, China
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Jinan, 250012, China
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Jinan, 250117, China
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Nanchang, 330029, China
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Nanjing, 2100008, China
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Nanjing, 210009, China
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Nanning, 530021, China
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Shenyang, 110004, China
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Shenyang, 110042, China
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Shijiazhuang, 050020, China
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Tianjin, 300060, China
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Wuhan, 430022, China
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Wuhan, 430079, China
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Xi'an, 710061, China
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Zhengzhou, 450008, China
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Nový Jičín, 741 01, Czechia
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Olomouc, 77900, Czechia
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Prague, 12808, Czechia
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Prague, 150 06, Czechia
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Aarhus, 8200, Denmark
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Amiens, 80054, France
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Avignon, 84000, France
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Paris, 75005, France
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Pau, 64046, France
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Saint-Herblain, 44805, France
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Saint-Priest-en-Jarez, 42271, France
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Tours, 37044, France
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Bonn, 53127, Germany
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Dresden, 01307, Germany
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Schwäbisch Hall, 74523, Germany
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Tübingen, 72076, Germany
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Wiesbaden, 65199, Germany
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Athens, 11528, Greece
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Athens, 14564, Greece
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Pátrai, 26332, Greece
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Bhubaneswar, 751007, India
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Delhi, 110029, India
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Dhanvantari Nagar, 605006, India
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Kolkata, 700017, India
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Nagpur, 440001, India
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Nashik, 422 009, India
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Surat, 395002, India
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Cork, T12 DV56, Ireland
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Dublin, D08 NHY1, Ireland
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Hadera, 38100, Israel
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Haifa, 34362, Israel
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Jerusalem, 00000, Israel
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Jerusalem, 91031, Israel
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Kfar Saba, 4428164, Israel
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Ramat Gan, 52621, Israel
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Tel Aviv, 64239, Israel
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Brescia, 25123, Italy
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Catania, 95126, Italy
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Florence, 50134, Italy
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Lecco, 23900, Italy
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Milan, 20133, Italy
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Milan, 20141, Italy
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Milan, 20159, Italy
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Milan, 20162, Italy
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Parma, 43126, Italy
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Pisa, 56126, Italy
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Roma, 00161, Italy
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Roma, 00168, Italy
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Torino, 10100, Italy
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Sendai, 980-8574, Japan
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Sunto-gun, 411-8777, Japan
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Tsu, 514-8507, Japan
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A Coruña, 15006, Spain
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Uppsala, 751 85, Sweden
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Tainan, 704, Taiwan
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London, EC1A 7BE, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2025
First Posted
October 20, 2025
Study Start
December 29, 2025
Primary Completion (Estimated)
November 17, 2028
Study Completion (Estimated)
May 27, 2030
Last Updated
January 16, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.