Epithelial Ovarian CancerPhase 3TREVI-OC-01NCT07218809
AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer
A Phase 3 study testing AZD5335, Mirvetuximab Soravtansine (MIRV) and Paclitaxel in people with Epithelial Ovarian Cancer, run by AstraZeneca at 299 sites in 24 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- AZD5335, Mirvetuximab Soravtansine (MIRV) and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 299 sitesin 24 countries
- Study dates
- 29 Dec 2025to 27 Dec 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
299 sites in 24 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
299 sites in 24 countries
United States40 sites, 39 recruiting
- Recruiting
Research Site
Billings, Montana, 59106
- Recruiting
Research Site
Birmingham, Alabama, 35223
- Recruiting
Research Site
Blue Ash, Ohio, 45242
- Recruiting
Research Site
Burlington, Massachusetts, 01805
- Not yet recruiting
Research Site
Camden, New Jersey, 08103
- Recruiting
Research Site
Chapel Hill, North Carolina, 27599
- Not yet recruiting
Research Site
Chicago, Illinois, 60612
- Recruiting
Research Site
Dayton, Ohio, 45459
- Not yet recruiting
Research Site
Evanston, Illinois, 60201
- Recruiting
Research Site
Fairfax, Virginia, 22031
- Not yet recruiting
Research Site
Fort Lauderdale, Florida, 33316
- Recruiting
Research Site
Fort Wayne, Indiana, 46845
- Recruiting
Research Site
Gainesville, Florida, 32608
- Recruiting
Research Site
Germantown, Tennessee, 38138
- Recruiting
Research Site
Indianapolis, Indiana, 46202
- Recruiting
Research Site
Jupiter, Florida, 33458
- Not yet recruiting
Research Site
La Jolla, California, 92037
- Recruiting
Research Site
Las Vegas, Nevada, 89106
- Not yet recruiting
Research Site
Lebanon, New Hampshire, 03756
- Not yet recruiting
Research Site
Little Rock, Arkansas, 72205
- Recruiting
Research Site
Louisville, Kentucky, 40241
- Recruiting
Research Site
Miami, Florida, 33176
- Recruiting
Research Site
Minneapolis, Minnesota, 55404
- Recruiting
Research Site
Omaha, Nebraska, 68114
- Recruiting
Research Site
Peoria, Illinois, 61637
- Recruiting
Research Site
Portland, Oregon, 97213
- Recruiting
Research Site
Roanoke, Virginia, 24016
- Withdrawn
Research Site
Salt Lake City, Utah, 84106
- Recruiting
Research Site
San Antonio, Texas, 78229
- Recruiting
Research Site
Seattle, Washington, 98104
- Recruiting
Research Site
Springfield, Missouri, 65807
- Not yet recruiting
Research Site
Sylvania, Ohio, 43560
- Not yet recruiting
Research Site
The Bronx, New York, 10461
- Recruiting
Research Site
Towson, Maryland, 21204
- Recruiting
Research Site
Tyler, Texas, 75702
- Recruiting
Research Site
Urbana, Illinois, 61801
- Recruiting
Research Site
Washington D.C., District of Columbia, 20010
- Not yet recruiting
Research Site
Weston, Florida, 33331
- Not yet recruiting
Research Site
Worcester, Massachusetts, 01655
- Not yet recruiting
Research Site
York, Pennsylvania, 17403
China39 sites, 39 recruiting
- Not yet recruiting
Research Site
Beijing, 100021
- Not yet recruiting
Research Site
Beijing, 100142
- Not yet recruiting
Research Site
Beijing, 102600
- Not yet recruiting
Research Site
Bengbu, 233004
- Not yet recruiting
Research Site
Changchun, 130012
- Not yet recruiting
Research Site
Changsha, 410008
- Not yet recruiting
Research Site
Changsha, 410013
- Not yet recruiting
Research Site
Chengdu, 610041
- Not yet recruiting
Research Site
Chongqing, 400030
- Not yet recruiting
Research Site
Fuzhou, 350011
- Not yet recruiting
Research Site
Guangzhou, 510000
- Not yet recruiting
Research Site
Guangzhou, 510060
- Not yet recruiting
Research Site
Guangzhou, 510080
- Not yet recruiting
Research Site
Hangzhou, 310003
- Not yet recruiting
Research Site
Hangzhou, 310006
- Not yet recruiting
Research Site
Hangzhou, 310022
- Not yet recruiting
Research Site
Harbin, 150049
- Not yet recruiting
Research Site
Jinan, 250012
- Not yet recruiting
Research Site
Jinan, 250117
- Not yet recruiting
Research Site
Lanzhou, 730000
- Not yet recruiting
Research Site
Linyi, 276000
- Not yet recruiting
Research Site
Nanchang, 330029
- Not yet recruiting
Research Site
Nanjing, 2100008
- Not yet recruiting
Research Site
Nanjing, 210009
- Not yet recruiting
Research Site
Nanning, 530021
- Not yet recruiting
Research Site
Shanghai, 200025
- Not yet recruiting
Research Site
Shanghai, 200032
- Not yet recruiting
Research Site
Shenyang, 110004
- Not yet recruiting
Research Site
Shenyang, 110042
- Not yet recruiting
Research Site
Shijiazhuang, 050020
- Not yet recruiting
Research Site
Taiyuan, 030000
- Not yet recruiting
Research Site
Tianjin, 300060
- Not yet recruiting
Research Site
Wuhan, 430022
- Recruiting
Research Site
Wuhan, 430030
- Not yet recruiting
Research Site
Wuhan, 430079
- Not yet recruiting
Research Site
Xi'an, 710061
- Not yet recruiting
Research Site
Zhanjiang, 524001
- Not yet recruiting
Research Site
Zhengzhou, 450008
- Not yet recruiting
Research Site
Zhengzhou, 450052
Japan20 sites, 20 recruiting
- Not yet recruiting
Research Site
Akashi-shi, 673-8558
- Not yet recruiting
Research Site
Chūōku, 104-0045
- Recruiting
Research Site
Hidaka-shi, 350-1298
- Not yet recruiting
Research Site
Kashiwa, 227-8577
- Recruiting
Research Site
Kobe, 650-0047
- Recruiting
Research Site
Kōtoku, 135-8550
- Recruiting
Research Site
Kurume-shi, 830-0011
- Not yet recruiting
Research Site
Nagoya, 464-8681
- Recruiting
Research Site
Niigata, 951-8566
- Not yet recruiting
Research Site
Okayama, 700-8558
- Recruiting
Research Site
Osaka, 541-8567
- Recruiting
Research Site
Sagamihara-shi, 252-0375
- Recruiting
Research Site
Sapporo, 003-0804
- Recruiting
Research Site
Sendai, 980-8574
- Recruiting
Research Site
Shinjuku-ku, 160-0023
- Recruiting
Research Site
Shinjuku-ku, 160-8582
- Recruiting
Research Site
Shiwa-gun, 028-3694
- Not yet recruiting
Research Site
Sunto-gun, 411-8777
- Recruiting
Research Site
Toon-Shi, 791-0295
- Recruiting
Research Site
Tsu, 514-8507
Germany17 sites, 17 recruiting
- Not yet recruiting
Research Site
Berlin, 13353
- Not yet recruiting
Research Site
Bonn, 53127
- Not yet recruiting
Research Site
Detmold, 32756
- Not yet recruiting
Research Site
Dresden, 01307
- Not yet recruiting
Research Site
Düsseldorf, 40225
- Not yet recruiting
Research Site
Essen, 45130
- Not yet recruiting
Research Site
Essen, 45147
- Not yet recruiting
Research Site
Frankfurt am Main, 60487
- Not yet recruiting
Research Site
Hamburg, 20246
- Not yet recruiting
Research Site
Hamburg, 22457
- Not yet recruiting
Research Site
Hanover, 30625
- Not yet recruiting
Research Site
Leipzig, 4103
- Not yet recruiting
Research Site
Mannheim, 68167
- Not yet recruiting
Research Site
Schwäbisch Hall, 74523
- Not yet recruiting
Research Site
Tübingen, 72076
- Not yet recruiting
Research Site
Ulm, 89075
- Not yet recruiting
Research Site
Wiesbaden, 65199
Australia14 sites, 14 recruiting
- Recruiting
Research Site
Adelaide, 5037
- Recruiting
Research Site
Auchenflower, 4066
- Recruiting
Research Site
Campbelltown, 2560
- Not yet recruiting
Research Site
Camperdown, 2050
- Not yet recruiting
Research Site
Clayton, 3168
- Not yet recruiting
Research Site
Cudgen, 2487
- Recruiting
Research Site
Garran, 2605
- Recruiting
Research Site
Gosford, 2250
- Recruiting
Research Site
Heidelberg, 3084
- Recruiting
Research Site
Kogarah, 2217
- Recruiting
Research Site
Melbourne, 3000
- Recruiting
Research Site
Richmond, 3121
- Recruiting
Research Site
St Leonards, 2065
- Recruiting
Research Site
Waratah, 2298
Brazil14 sites, 14 recruiting
- Not yet recruiting
Research Site
Barretos, 14784-400
- Not yet recruiting
Research Site
Bela Vista, 1317
- Not yet recruiting
Research Site
Curitiba, 81520-060
- Not yet recruiting
Research Site
Goiânia, 74110-060
- Not yet recruiting
Research Site
Natal, 59075-740
- Not yet recruiting
Research Site
Porto Alegre, 90020-090
- Not yet recruiting
Research Site
Porto Alegre, 90035-903
- Not yet recruiting
Research Site
Porto Alegre, 90610-000
- Not yet recruiting
Research Site
Porto Alegre, 91350200
- Not yet recruiting
Research Site
Porto Velho, 76834-899
- Not yet recruiting
Research Site
Rio de Janeiro, 20230-130
- Not yet recruiting
Research Site
São José do Rio Preto, 15090-000
- Not yet recruiting
Research Site
São Paulo, 01401-002
- Not yet recruiting
Research Site
São Paulo, 01409-902
Italy14 sites, 14 recruiting
- Not yet recruiting
Research Site
Brescia, 25123
- Not yet recruiting
Research Site
Catania, 95126
- Not yet recruiting
Research Site
Florence, 50134
- Not yet recruiting
Research Site
Lecco, 23900
- Not yet recruiting
Research Site
Milan, 20133
- Not yet recruiting
Research Site
Milan, 20141
- Not yet recruiting
Research Site
Milan, 20159
- Not yet recruiting
Research Site
Milan, 20162
- Not yet recruiting
Research Site
Naples, 80131
- Not yet recruiting
Research Site
Parma, 43126
- Not yet recruiting
Research Site
Pisa, 56126
- Not yet recruiting
Research Site
Roma, 00161
- Not yet recruiting
Research Site
Roma, 00168
- Not yet recruiting
Research Site
Torino, 10100
Israel13 sites, 12 recruiting
- Not yet recruiting
Research Site
Afula, 1834111
- Recruiting
Research Site
Beersheba, 84101
- Recruiting
Research Site
Hadera, 38100
- Recruiting
Research Site
Haifa, 3109601
- Recruiting
Research Site
Haifa, 34362
- Recruiting
Research Site
Holon, 5822012
- Recruiting
Research Site
Jerusalem, 00000
- Recruiting
Research Site
Jerusalem, 91031
- Recruiting
Research Site
Kfar Saba, 4428164
- Recruiting
Research Site
Nahariya, 22100
- Not yet recruiting
Research Site
Ramat Gan, 52621
- Withdrawn
Research Site
Sofia, 1680
- Recruiting
Research Site
Tel Aviv, 64239
France12 sites, 12 recruiting
- Not yet recruiting
Research Site
Amiens, 80054
- Recruiting
Research Site
Avignon, 84000
- Not yet recruiting
Research Site
Nîmes, 30029
- Recruiting
Research Site
Paris, 75005
- Recruiting
Research Site
Pau, 64046
- Recruiting
Research Site
Pierre-Bénite, 69310
- Not yet recruiting
Research Site
Plerin SUR MER, 22190
- Not yet recruiting
Research Site
Reims, 51056
- Recruiting
Research Site
Saint-Herblain, 44805
- Recruiting
Research Site
Saint-Priest-en-Jarez, 42271
- Not yet recruiting
Research Site
Toulouse, 31300
- Recruiting
Research Site
Tours, 37044
South Korea12 sites, 12 recruiting
- Recruiting
Research Site
Busan, 49241
- Recruiting
Research Site
Daegu, 42601
- Recruiting
Research Site
Goyang-si, 10408
- Recruiting
Research Site
Seongnam-si, 13620
- Recruiting
Research Site
Seoul, 03080
- Recruiting
Research Site
Seoul, 03722
- Recruiting
Research Site
Seoul, 06273
- Recruiting
Research Site
Seoul, 06351
- Recruiting
Research Site
Seoul, 08308
- Recruiting
Research Site
Seoul, 5505
- Recruiting
Research Site
Suwon, 16499
- Recruiting
Research Site
Yangsan, 50612
United Kingdom12 sites, 12 recruiting
- Recruiting
Research Site
Barrow in Furness, LA14 4LF
- Not yet recruiting
Research Site
Birmingham, B152GW
- Not yet recruiting
Research Site
Cambridge, CB2 0QQ
- Not yet recruiting
Research Site
Canterbury, CT1 3NG
- Not yet recruiting
Research Site
Cardiff, CF15 7QZ
- Recruiting
Research Site
Edinburgh, EH4 2XU
- Recruiting
Research Site
Greater London, SW3 6JJ
- Recruiting
Research Site
London, EC1A 7BE
- Not yet recruiting
Research Site
London, SE1 9RT
- Recruiting
Research Site
Nottingham, NG5 1PB
- Recruiting
Research Site
Sutton, SM2 5PT
- Recruiting
Research Site
Swansea, SA12 7BR
Spain10 sites, 10 recruiting
- Not yet recruiting
Research Site
A Coruña, 15006
- Not yet recruiting
Research Site
Badalona, 08916
- Not yet recruiting
Research Site
Barcelona, 08036
- Not yet recruiting
Research Site
Córdoba, 14004
- Not yet recruiting
Research Site
Donostia / San Sebastian, 20014
- Not yet recruiting
Research Site
Girona, 17007
- Not yet recruiting
Research Site
L'Hospitalet de Llobregat, 08908
- Not yet recruiting
Research Site
Madrid, 28034
- Not yet recruiting
Research Site
Madrid, 28041
- Not yet recruiting
Research Site
Valencia, 46010
Chile9 sites, 9 recruiting
- Not yet recruiting
Research Site
Port Montt, 5480000
- Not yet recruiting
Research Site
Providencia, 7510032
- Not yet recruiting
Research Site
Santiago, 7500587
- Not yet recruiting
Research Site
Santiago, 7500653
- Not yet recruiting
Research Site
Santiago, 7520426
- Not yet recruiting
Research Site
Santiago, 8330032
- Not yet recruiting
Research Site
Santiago, 8331143
- Not yet recruiting
Research Site
Santiago, 8420383
- Not yet recruiting
Research Site
Viña del Mar, 2520000
India9 sites, 9 recruiting
- Not yet recruiting
Research Site
Bhubaneswar, 751007
- Not yet recruiting
Research Site
Chennai, 600113
- Not yet recruiting
Research Site
Delhi, 110029
- Not yet recruiting
Research Site
Dhanvantari Nagar, 605006
- Not yet recruiting
Research Site
Kolkata, 700017
- Not yet recruiting
Research Site
Nagpur, 440001
- Not yet recruiting
Research Site
Nashik, 422 009
- Not yet recruiting
Research Site
Surat, 395002
- Not yet recruiting
Research Site
Tiruchirappalli, 620008
Taiwan9 sites, 9 recruiting
- Not yet recruiting
Research Site
Changhua
- Not yet recruiting
Research Site
New Taipei City, 220
- Not yet recruiting
Research Site
Taichung, 40447
- Not yet recruiting
Research Site
Taichung, 40705
- Not yet recruiting
Research Site
Tainan, 704
- Not yet recruiting
Research Site
Tainan, 73657
- Recruiting
Research Site
Taipei, 100
- Not yet recruiting
Research Site
Taipei, 11259
- Not yet recruiting
Research Site
Taoyuan, 333
Greece8 sites, 8 recruiting
- Not yet recruiting
Research Site
Athens, 11528
- Not yet recruiting
Research Site
Athens, 12462
- Not yet recruiting
Research Site
Athens, 14564
- Not yet recruiting
Research Site
Athens, 15123
- Not yet recruiting
Research Site
Kalamata, 24100
- Not yet recruiting
Research Site
Pátrai, 26332
- Not yet recruiting
Research Site
Rio, 26504
- Not yet recruiting
Research Site
Thessaloniki, 55236
Canada7 sites, 7 recruiting
- Not yet recruiting
Research Site
Edmonton, Alberta, T6G 1Z2
- Not yet recruiting
Research Site
Hamilton, Ontario, L8V 5C2
- Not yet recruiting
Research Site
Kingston, Ontario, K7L 2V7
- Not yet recruiting
Research Site
Montreal, Quebec, H1T 2M4
- Not yet recruiting
Research Site
Montreal, Quebec, H3T 1E2
- Not yet recruiting
Research Site
Montreal, Quebec, H4A 3J1
- Not yet recruiting
Research Site
Québec, G1G 5X1
Czechia7 sites, 7 recruiting
- Not yet recruiting
Research Site
Brno, 625 00
- Not yet recruiting
Research Site
Hradec Králové, 500 05
- Not yet recruiting
Research Site
Nový Jičín, 741 01
- Not yet recruiting
Research Site
Olomouc, 77900
- Not yet recruiting
Research Site
Prague, 12808
- Not yet recruiting
Research Site
Prague, 150 06
- Not yet recruiting
Research Site
Prague, 18000
Thailand7 sites, 7 recruiting
- Not yet recruiting
Research Site
Bangkok, 10210
- Not yet recruiting
Research Site
Bangkok, 10400
- Recruiting
Research Site
Bangkok, 10700
- Not yet recruiting
Research Site
Chiang Mai, 50200
- Not yet recruiting
Research Site
Dusit, 10300
- Not yet recruiting
Research Site
Khon Kaen, 40002
- Not yet recruiting
Research Site
Songkhla, 90110
Belgium6 sites, 6 recruiting
- Not yet recruiting
Research Site
Charleroi, 6060
- Not yet recruiting
Research Site
Edegem, 2650
- Recruiting
Research Site
Ghent, 9000
- Recruiting
Research Site
Leuven, 3000
- Recruiting
Research Site
Libramont-Chevigny, 6800
- Recruiting
Research Site
Namur, 5000
Switzerland6 sites, 6 recruiting
- Not yet recruiting
Research Site
Basel, 4031
- Not yet recruiting
Research Site
Münsterlingen, 8596
- Not yet recruiting
Research Site
Sankt Gallen, 9007
- Not yet recruiting
Research Site
Thun, 3600
- Not yet recruiting
Research Site
Zollikerberg, CH-8125
- Not yet recruiting
Research Site
Zurich, 8091
Ireland5 sites, 5 recruiting
- Not yet recruiting
Research Site
Cork, T12 DV56
- Not yet recruiting
Research Site
Dublin, 7
- Not yet recruiting
Research Site
Dublin, D08 NHY1
- Not yet recruiting
Research Site
Dublin, DO4YN63
- Not yet recruiting
Research Site
Waterford, X91 ER8E
Sweden5 sites, 5 recruiting
- Not yet recruiting
Research Site
Linköping, 581 85
- Not yet recruiting
Research Site
Lund, 22242
- Not yet recruiting
Research Site
Solna, 171 64
- Not yet recruiting
Research Site
Umeå, 90737
- Not yet recruiting
Research Site
Uppsala, 751 85
Denmark4 sites, 4 recruiting
- Not yet recruiting
Research Site
Aalborg, 9000
- Not yet recruiting
Research Site
Aarhus, 8200
- Not yet recruiting
Research Site
Odense, 5000
- Not yet recruiting
Research Site
Vejle, 7100
About this study
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)
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.
Read the 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.
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- AZD5335, Mirvetuximab Soravtansine (MIRV), Paclitaxel, Pegylated liposomal Doxorubicin (PLD), Topotecan
- Keywords
- Epithelial Ovarian Cancer, Peritoneal Cancer, Follopian Tube Cancer, Platinum Resistant Ovarian Cancer
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5335Drug
antibody drug conjugate
Mirvetuximab Soravtansine (MIRV)Drug
Also called Elahere
antibody drug conjugate
PaclitaxelDrug
Also called Taxol; Onxol
chemotherapy
Pegylated liposomal Doxorubicin (PLD)Drug
Also called Doxil; Caelyx
chemotherapy
TopotecanDrug
Also called Hycamtin
chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| AZD5335 in FRa-high cohort | Experimental | AZD5335 IV (intravenous) in FRa-high cohort Receives: Drug: AZD5335 |
| Mirvetuximab Soravtansine (MIRV) in FRa-high cohort | Active comparator | MIRV AIBW IV in FRa-high cohort Receives: Drug: Mirvetuximab Soravtansine (MIRV) |
| AZD5335 in FRa-low cohort | Experimental | AZD5335 IV (intravenous) in FRa-low cohort Receives: Drug: AZD5335 |
| Investigator´s choice chemotherapy in FRa-low cohort | Active comparator | Investigator's choice of chemotherapy Paclitaxel IV Pegylated liposomal Doxorubicin (PLD) IV or Topotecan IV in FRa-low cohor Receives: Drug: Paclitaxel; Drug: Pegylated liposomal Doxorubicin (PLD); Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 5 years
Secondary outcomes (1)
Overall survival (OS)
OS is defined as the time from randomisation until the date of death due to any cause.
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start29 Dec 2025
- Primary completion17 Nov 2028 (estimated)
- Study completion27 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation, Ventana Medical Systems, Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218809
- Sponsor's protocol ID
- D8991C00001
- Acronym
- TREVI-OC-01
- Status last verified
- Jul 2026
- First submitted
- 16 Oct 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.