Epithelial Ovarian CancerPhase 3TREVI-OC-02NCT07851025

Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer

A Phase 3 study testing Torvutatug samrotecan and Bevacizumab in people with Epithelial Ovarian Cancer, run by AstraZeneca at 220 sites in 29 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

This study will evaluate the efficacy, safety and tolerability of Torvutatug samrotecan (torvu-sam) in combination with bevacizumab compared with bevacizumab monotherapy as first line maintenance treatment in patients with non-Homologous Recombination Deficient (non-HRD) positive advanced ovarian cancer. 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?: Torvutatug samrotecan and Bevacizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 950 participants
Where: 220 sitesin 29 countries
Study dates: 16 Sep 2026to 29 Aug 2033
Phase: Phase 3
Are there results?: Not yet: the study is under way

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 newly diagnosed FIGO Stage III/IV, histologically confirmed epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma
Provision of an archival FFPE tumour sample
Participants who have completed at least 6 cycles and a maximum of 8 cycles of first-line Platinum-based chemotherapy (PBC) prior to randomisation
Participants must have received a minimum of 3 cycles of bevacizumab in combination with the 3 last cycles of PBC, prior to randomisation
Participants who have completed cytoreductive surgery or have inoperable disease
Participants with non-progressive disease upon completion of front-line induction therapy

Who cannot join

Participants with tumours of non-epithelial origin, borderline tumours, or low-grade epithelial tumours
BRCA1/2 mutation (germline or somatic) or HRD positive, unknown, or inconclusive tumour status
Participants with history of (non-infectious) ILD/pneumonitis that required steroids or supplemental oxygen, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
Participants with non-healing wound, active ulcer, or bone fracture
Participants with evidence of active or ongoing bowel obstruction
Prior exposure to any FRα-targeted therapy, including MIRV, or any TOP1i Antibody-drug Conjugate (ADC)

Trial locations and contacts

220 sites in 29 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Country

City, postcode or hospital

Sites recruiting now only

220 sites in 29 countries

China40 sites, 40 recruiting

Research Site
Anyang, 455000
Not yet recruiting
Research Site
Beijing, 100034
Not yet recruiting
Research Site
Beijing, 100036
Not yet recruiting
Research Site
Beijing, 100210
Not yet recruiting
Research Site
Beijing, 100730
Not yet recruiting
Research Site
Binzhou Shi, 256603
Not yet recruiting
Research Site
Changchun, 130021
Not yet recruiting
Research Site
Changsha, 410013
Not yet recruiting
Research Site
Chengdu, 610072
Not yet recruiting
Research Site
Chongqing, 400030
Not yet recruiting
Research Site
Fuzhou, 350014
Not yet recruiting
Research Site
Guangzhou, 510080
Not yet recruiting
Research Site
Haikou, 570311
Not yet recruiting
Research Site
Hangzhou, 310003
Not yet recruiting
Research Site
Hangzhou, 310022
Not yet recruiting
Research Site
Hangzhou, 310052
Not yet recruiting
Research Site
Hefei, 230031
Not yet recruiting
Research Site
Huangpu District, 200025
Not yet recruiting
Research Site
Jinan, 250021
Not yet recruiting
Research Site
Jinan, 250117
Not yet recruiting
Research Site
Linyi, 276001
Not yet recruiting
Research Site
Luoyang, 471003
Not yet recruiting
Research Site
Luzhou, 646000
Not yet recruiting
Research Site
Nanchang, 330006
Not yet recruiting
Research Site
Nanjing, 210000
Not yet recruiting
Research Site
Nanjing, 210009
Not yet recruiting
Research Site
Nanning, 530021
Not yet recruiting
Research Site
Neijiang, 641000
Not yet recruiting
Research Site
Shanghai, 200011
Not yet recruiting
Research Site
Shanghai, 200032
Not yet recruiting
Research Site
Shantou
Not yet recruiting
Research Site
Shenzhen, 518039
Not yet recruiting
Research Site
Shijiazhuang, 050000
Not yet recruiting
Research Site
Suzhou, 215004
Not yet recruiting
Research Site
Taiyuan, 030013
Not yet recruiting
Research Site
Weifang, 261000
Not yet recruiting
Research Site
Wenzhou, 325015
Not yet recruiting
Research Site
Wuhan, 430060
Not yet recruiting
Research Site
Xinxiang, 453100
Not yet recruiting
Research Site
Xuzhou, 221009
Not yet recruiting

Other trials in China

Japan29 sites, 29 recruiting

Research Site
Fukushima, 960-1295
Not yet recruiting
Research Site
Ginowan-shi, 901-2725
Not yet recruiting
Research Site
Hidaka-shi, 350-1298
Not yet recruiting
Research Site
Isehara-shi, 259-1193
Not yet recruiting
Research Site
Kashiwa-shi, 277-8567
Not yet recruiting
Research Site
Kawasaki-shi, 216-8511
Not yet recruiting
Research Site
Kobe, 650-0047
Not yet recruiting
Research Site
Kōtoku, 135-8550
Not yet recruiting
Research Site
Kurume-shi, 830-0011
Not yet recruiting
Research Site
Kyoto, 612-8555
Not yet recruiting
Research Site
Minatoku, 105-8471
Not yet recruiting
Research Site
Nagoya, 464-8681
Not yet recruiting
Research Site
Nagoya, 466-8560
Not yet recruiting
Research Site
Niigata, 951-8520
Not yet recruiting
Research Site
Osaka, 541-8567
Not yet recruiting
Research Site
Osaka, 545-8586
Not yet recruiting
Research Site
Ota-shi, 373-8550
Not yet recruiting
Research Site
Sagamihara-shi, 252-0375
Not yet recruiting
Research Site
Sapporo, 003-0804
Not yet recruiting
Research Site
Sapporo, 060-8543
Not yet recruiting
Research Site
Sendai, 980-8574
Not yet recruiting
Research Site
Shinjuku-ku, 160-8582
Not yet recruiting
Research Site
Shiwa-gun, 028-3695
Not yet recruiting
Research Site
Suita, 565-0871
Not yet recruiting
Research Site
Sunto-gun, 411-8777
Not yet recruiting
Research Site
Toon-Shi, 791-0295
Not yet recruiting
Research Site
Tsu, 514-8507
Not yet recruiting
Research Site
Yokohama, 236-0004
Not yet recruiting
Research Site
Yokohama, 241-8515
Not yet recruiting

Other trials in Japan

Argentina12 sites, 12 recruiting

Research Site
Buenos Aires, C1122AAL
Not yet recruiting
Research Site
Buenos Aires, C1125ABD
Not yet recruiting
Research Site
Capital Federal, 1118
Not yet recruiting
Research Site
Ciudad de Buenos Aires, 1015
Not yet recruiting
Research Site
Ciudad de Buenos Aires, 1426
Not yet recruiting
Research Site
Córdoba, X5000AAW
Not yet recruiting
Research Site
Córdoba, X5000HXK
Not yet recruiting
Research Site
Córdoba, X5008HHW
Not yet recruiting
Research Site
Rosario, S2000KZE
Not yet recruiting
Research Site
Salta, A4400EMI
Not yet recruiting
Research Site
Santa Fe, S2002RE
Not yet recruiting
Research Site
Viedma, R8500ACE
Not yet recruiting

Other trials in Argentina

South Korea12 sites, 12 recruiting

Research Site
Busan, 49241
Not yet recruiting
Research Site
Daegu, 42601
Not yet recruiting
Research Site
Goyang-si, 10408
Not yet recruiting
Research Site
Gyeonggi-do, 13620
Not yet recruiting
Research Site
Seongnam-si, 13496
Not yet recruiting
Research Site
Seoul, 03080
Not yet recruiting
Research Site
Seoul, 03722
Not yet recruiting
Research Site
Seoul, 06273
Not yet recruiting
Research Site
Seoul, 06351
Not yet recruiting
Research Site
Seoul, 06591
Not yet recruiting
Research Site
Seoul, 5505
Not yet recruiting
Research Site
Yangsan, 50612
Not yet recruiting

Other trials in South Korea

Taiwan12 sites, 12 recruiting

Research Site
Kaohsiung City, 81362
Not yet recruiting
Research Site
Kaohsiung City, 833401
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, 70403
Not yet recruiting
Research Site
Tainan, 73657
Not yet recruiting
Research Site
Taipei, 100
Not yet recruiting
Research Site
Taipei, 10449
Not yet recruiting
Research Site
Taipei, 11217
Not yet recruiting
Research Site
Taipei, 11259
Not yet recruiting
Research Site
Taoyuan, 333
Not yet recruiting

Other trials in Taiwan

Australia11 sites, 11 recruiting

Research Site
Auchenflower, 4066
Recruiting
Research Site
Benowa, 4217
Not yet recruiting
Research Site
Hobart, 7000
Not yet recruiting
Research Site
Kingswood, 2747
Not yet recruiting
Research Site
Nedlands, 6009
Not yet recruiting
Research Site
Port Macquarie, 2444
Not yet recruiting
Research Site
Randwick, 2031
Not yet recruiting
Research Site
Richmond, 3121
Not yet recruiting
Research Site
Toorak Gardens, 5065
Not yet recruiting
Research Site
Wollongong, 2500
Not yet recruiting
Research Site
Woodville, 5011
Not yet recruiting

Other trials in Australia

India11 sites, 11 recruiting

Research Site
Ansārinagar, 110 029
Not yet recruiting
Research Site
Bhubaneswar, 751007
Not yet recruiting
Research Site
Hyderabad, 500004
Not yet recruiting
Research Site
Mumbai, 400012
Not yet recruiting
Research Site
Mumbai, 400016
Not yet recruiting
Research Site
Nagpur, 440001
Not yet recruiting
Research Site
Nashik, 422 009
Not yet recruiting
Research Site
New Delhi, 110 085
Not yet recruiting
Research Site
New Delhi, 110029
Not yet recruiting
Research Site
Pune, 411004
Not yet recruiting
Research Site
Thiruvananthapuram, 695011
Not yet recruiting

Other trials in India

Brazil10 sites, 10 recruiting

Research Site
Fortaleza, 60336-045
Not yet recruiting
Research Site
Itajaí, 88301-220
Not yet recruiting
Research Site
Jaú, 17210-080
Not yet recruiting
Research Site
Natal, 59075-740
Not yet recruiting
Research Site
Porto Alegre, 90020-090
Not yet recruiting
Research Site
Rio de Janeiro, 20230-130
Not yet recruiting
Research Site
Salvador, 41253-190
Not yet recruiting
Research Site
São Paulo, 01317-000
Not yet recruiting
Research Site
São Paulo, 01409-902
Not yet recruiting
Research Site
São Paulo, 04014-002
Not yet recruiting

Other trials in Brazil

Israel8 sites, 8 recruiting

Research Site
Hadera, 38100
Recruiting
Research Site
Haifa, 31096
Recruiting
Research Site
Haifa, 34362
Not yet recruiting
Research Site
Holon, 5822012
Not yet recruiting
Research Site
Jerusalem, 9103102
Recruiting
Research Site
Kfar Saba, 44281
Not yet recruiting
Research Site
Nahariya, 22100
Not yet recruiting
Research Site
Tel Aviv, 6423906
Not yet recruiting

Other trials in Israel

France7 sites, 7 recruiting

Research Site
Brest, 29200
Not yet recruiting
Research Site
Dijon, 21000
Not yet recruiting
Research Site
Lyon, 69008
Not yet recruiting
Research Site
Marseille, 13009
Not yet recruiting
Research Site
Paris, 75014
Not yet recruiting
Research Site
Saint-Priest-en-Jarez, 42270
Not yet recruiting
Research Site
Toulouse, 31059
Not yet recruiting

Other trials in France

United States6 sites, 6 recruiting

Research Site
Baltimore, Maryland, 21201
Not yet recruiting
Research Site
Baton Rouge, Louisiana, 70808
Not yet recruiting
Research Site
Billings, Montana, 59106
Not yet recruiting
Research Site
Cleveland, Ohio, 44195
Not yet recruiting
Research Site
Tamarac, Florida, 33321
Not yet recruiting
Research Site
Tampa, Florida, 33606
Not yet recruiting

Other trials in United States

Bulgaria6 sites, 6 recruiting

Research Site
Dobrich, 9300
Not yet recruiting
Research Site
Plovdiv, 4000
Not yet recruiting
Research Site
Shumen, 9700
Not yet recruiting
Research Site
Sofia, 1330
Not yet recruiting
Research Site
Sofia, 1407
Not yet recruiting
Research Site
Sofia, 1797
Not yet recruiting

Other trials in Bulgaria

Germany6 sites, 6 recruiting

Research Site
Berlin, 12559
Not yet recruiting
Research Site
Berlin, 13353
Not yet recruiting
Research Site
Bonn, 53127
Not yet recruiting
Research Site
Düsseldorf, 40225
Not yet recruiting
Research Site
Hanover, 30625
Not yet recruiting
Research Site
Wiesbaden, 65199
Not yet recruiting

Other trials in Germany

Colombia5 sites, 5 recruiting

Research Site
Bogotá, 110221
Not yet recruiting
Research Site
Bogotá
Not yet recruiting
Research Site
Medellín, 050030
Not yet recruiting
Research Site
Medellín, 50018
Not yet recruiting
Research Site
Pasto, 520002
Not yet recruiting

Other trials in Colombia

Greece5 sites, 5 recruiting

Research Site
Athens, 11528
Not yet recruiting
Research Site
Athens, 155 62
Not yet recruiting
Research Site
Pátrai, 26332
Not yet recruiting
Research Site
Rio, 265 04
Not yet recruiting
Research Site
Thessaloniki, 55236
Not yet recruiting

Other trials in Greece

Italy5 sites, 5 recruiting

Research Site
Florence, 50134
Not yet recruiting
Research Site
Genova, 16132
Not yet recruiting
Research Site
Milan, 20141
Not yet recruiting
Research Site
Milan, 20121
Not yet recruiting
Research Site
Parma, 43126
Not yet recruiting

Other trials in Italy

Peru5 sites, 5 recruiting

Research Site
Arequipa, AREQUIPA01
Not yet recruiting
Research Site
Lima, 15036
Not yet recruiting
Research Site
Lima, 15038
Not yet recruiting
Research Site
Lima, LIMA 32
Not yet recruiting
Research Site
Wanchac, 8002
Not yet recruiting

Other trials in Peru

Chile4 sites, 4 recruiting

Research Site
Santiago, 7520426
Not yet recruiting
Research Site
Santiago
Not yet recruiting
Research Site
Temuco, 4780000
Not yet recruiting
Research Site
Viña del Mar, 2540364
Not yet recruiting

Other trials in Chile

Malaysia4 sites, 4 recruiting

Research Site
Kuala Lumpur, 59100
Not yet recruiting
Research Site
Kuala Selangor, 46050
Not yet recruiting
Research Site
Kuala Selangor, 62250
Not yet recruiting
Research Site
Petaling Jaya, 46300
Not yet recruiting

Other trials in Malaysia

Philippines4 sites, 4 recruiting

Research Site
Cebu, 6000
Not yet recruiting
Research Site
City of Muntinlupa, 1780
Not yet recruiting
Research Site
Manila, 1000
Not yet recruiting
Research Site
Quezon, 1102
Not yet recruiting

Other trials in Philippines

Spain4 sites, 4 recruiting

Research Site
Barcelona, 08003
Not yet recruiting
Research Site
Barcelona, 08025
Not yet recruiting
Research Site
Palma de Mallorca, 07120
Not yet recruiting
Research Site
Patraix, 46017
Not yet recruiting

Other trials in Spain

Georgia3 sites, 3 recruiting

Research Site
Batumi, 6000
Not yet recruiting
Research Site
Tbilisi, 0159
Not yet recruiting
Research Site
Tbilisi, 0186
Not yet recruiting

Other trials in Georgia

Thailand3 sites, 3 recruiting

Research Site
Bangkok, 10210
Not yet recruiting
Research Site
Bangkok, 10300
Not yet recruiting
Research Site
Bangkok, 10330
Not yet recruiting

Other trials in Thailand

Canada2 sites, 2 recruiting

Research Site
Montreal, Quebec, H4A 3J1
Not yet recruiting
Research Site
Toronto, Ontario, M5G 2M9
Not yet recruiting

Other trials in Canada

Slovakia2 sites, 2 recruiting

Research Site
Bratislava, 833 10
Not yet recruiting
Research Site
Trenčín, 81171
Not yet recruiting

Other trials in Slovakia

Estonia1 site, 1 recruiting

Research Site
Tartu, 51014
Not yet recruiting

Other trials in Estonia

Poland1 site, 1 recruiting

Research Site
Olsztyn, 10-561
Not yet recruiting

Other trials in Poland

Slovenia1 site, 1 recruiting

Research Site
Ljubljana, 1000
Not yet recruiting

Other trials in Slovenia

United Kingdom1 site, 1 recruiting

Research Site
Cambridge, CB2 0QQ
Not yet recruiting

Other trials in United Kingdom

About this study

Official title: A Randomised, Open-label, Phase III Study of Torvutatug Samrotecan in Combination With Bevacizumab Versus Bevacizumab Monotherapy as First-line Maintenance Treatment in Participants With Non-HRD Positive Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (TREVI-OC-02)

Read the detailed description

This study aims to see if maintenance treatment with torvu-sam in combination with bevacizumab allows patients to live longer without the cancer getting worse, compared to patients receiving bevacizumab.

Eligible patients will be those with advanced ovarian cancer who have not progressed following completion of first-line platinum-based chemotherapy (PBC) and bevacizumab.

Conditions: Epithelial Ovarian Cancer
Being tested: Torvutatug samrotecan, Bevacizumab
Keywords: Epithelial ovarian cancer, Fallopian tube cancer, Primary peritoneal cancer, Folate receptor alpha, Antibody-drug conjugate, TREVI-OC-02, Torvutatug samrotecan, Torvu-sam, Homologous recombination deficiency (HRD), Non-HRD positive
Medical subject headings: Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Torvutatug samrotecanDrug
Also called AZD5335, Torvu-sam
Antibody drug conjugate
BevacizumabDrug
Also called Avastin, Vegzelma
Monoclonal antibody inhibitor of Vascular Endothelial Growth Factor

Study groups in NCT07851025
Study group	Role	What they receive
Torvutatug samrotecan + Bevacizumab	Experimental	Torvutatug samrotecan IV (intravenous) + Bevacizumab IV Receives: Drug: Torvutatug samrotecan; Drug: Bevacizumab
Bevacizumab	Active comparator	Bevacizumab IV Receives: Drug: Bevacizumab

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 BICR per RECIST v1.1, or death due to any cause.
Measured: up to approximately 5 years

Secondary outcomes (6)

Overall Survival (OS)
OS is defined as the time from randomization until the date of death due to any cause.
Measured: up to approximately 7 years
Second progression free survival (PFS2)
PFS2 is defined as time from randomisation to the earliest of the progression event (following the initial investigator-assessed progression) after first subsequent therapy, or death.
Measured: up to approximately 5 years
Time to First Subsequent Therapy (TFST)
TFST is defined as time from randomisation until the start date of the first subsequent anti-cancer therapy after discontinuation of randomised treatment, or death due to any cause.
Measured: up to approximately 7 years
Time to Second Subsequent Therapy (TSST)
TSST is defined as time from randomisation until the start date of the second subsequent anti-cancer therapy after discontinuation of randomised treatment, or death due to any cause.
Measured: up to approximately 7 years
Health-related Quality of Life (HrQoL)
Change from baseline and time to deterioration in global health status/quality of life (GHS/QoL), physical functioning (PF), and ovarian cancer symptoms (EORTC IL433).
Measured: up to approximately 5 years
Number and percentage of participants with adverse events as graded by CTCAE v6 criteria
Adverse Event Incidence
Measured: up to approximately 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Sep 202629 Aug 2033

First posted1 Oct 2026
Study start16 Sep 2026
Primary completion28 Jun 2030 (estimated)
Study completion29 Aug 2033 (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: 950 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07851025
Sponsor's protocol ID: D8994C00001
Other IDs: 2026-526895-22-00, GOG-3149, ENGOT-ov110, 180099
Acronym: TREVI-OC-02
Status last verified: Nov 2026
First submitted: 15 Sep 2026
Last updated: 6 Nov 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.

Interested in taking part?

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor

All Epithelial Ovarian Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Open-label, Phase III Study of Torvutatug Samrotecan in Combination With Bevacizumab Versus Bevacizumab Monotherapy as First-line Maintenance Treatment in Participants With Non-HRD Positive Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (TREVI-OC-02)
ClinicalTrials.gov ID: NCT07851025
Acronym / sponsor ID: TREVI-OC-02 / D8994C00001
Conditions: Epithelial Ovarian Cancer
Keywords: Epithelial ovarian cancer, Fallopian tube cancer, Primary peritoneal cancer, Folate receptor alpha, Antibody-drug conjugate, TREVI-OC-02, Torvutatug samrotecan, Torvu-sam
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 950 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation
Study start: 16 Sep 2026 (actual)
Primary completion: 28 Jun 2030 (estimated)
Study completion: 29 Aug 2033 (estimated)
First posted: 1 Oct 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Eligible patients will be those with advanced ovarian cancer who have not progressed following completion of first-line platinum-based chemotherapy (PBC) and bevacizumab.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Torvutatug samrotecan + Bevacizumab	Experimental	Drug: Torvutatug samrotecan, Drug: BevacizumabTorvutatug samrotecan IV (intravenous) + Bevacizumab IV
Bevacizumab	Active comparator	Drug: BevacizumabBevacizumab IV

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Participants with newly diagnosed FIGO Stage III/IV, histologically confirmed epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma
Provision of an archival FFPE tumour sample
Participants who have completed at least 6 cycles and a maximum of 8 cycles of first-line Platinum-based chemotherapy (PBC) prior to randomisation
Participants must have received a minimum of 3 cycles of bevacizumab in combination with the 3 last cycles of PBC, prior to randomisation
Participants who have completed cytoreductive surgery or have inoperable disease

Key exclusion criteria (6 listed)

Participants with tumours of non-epithelial origin, borderline tumours, or low-grade epithelial tumours
BRCA1/2 mutation (germline or somatic) or HRD positive, unknown, or inconclusive tumour status
Participants with history of (non-infectious) ILD/pneumonitis that required steroids or supplemental oxygen, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
Participants with non-healing wound, active ulcer, or bone fracture
Participants with evidence of active or ongoing bowel obstruction

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Torvutatug samrotecanAlso: AZD5335, Torvu-samAntibody drug conjugate	Drug	Torvutatug samrotecan + Bevacizumab
BevacizumabAlso: Avastin, VegzelmaMonoclonal antibody inhibitor of Vascular Endothelial Growth Factor	Drug	Bevacizumab, Torvutatug samrotecan + Bevacizumab

Primary outcome

Progression Free Survival (PFS)
Time frame: up to approximately 5 years
PFS is defined as the time from randomization to radiographic progression as assessed by BICR per RECIST v1.1, or death due to any cause.

6 secondary outcomes

Overall Survival (OS)
Time frame: up to approximately 7 years
Second progression free survival (PFS2)
Time frame: up to approximately 5 years
Time to First Subsequent Therapy (TFST)
Time frame: up to approximately 7 years
Time to Second Subsequent Therapy (TSST)
Time frame: up to approximately 7 years
Health-related Quality of Life (HrQoL)
Time frame: up to approximately 5 years
Number and percentage of participants with adverse events as graded by CTCAE v6 criteria
Time frame: up to approximately 7 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
Individual participant dataSharing planned: 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.

Related trials for Epithelial Ovarian Cancer

Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

220 sites in 29 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Torvutatug samrotecan and Bevacizumab in people with Epithelial Ovarian Cancer, run by AstraZeneca at 220 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 220 sites in China, Japan, Argentina, South Korea, Taiwan and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: up to approximately 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07851025.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.