Platinum-sensitive Relapsed Epithelial Ovarian CancerPhase 3TREVI-OC-03NCT07816666

Torvutatug Samrotecan With or Without Bevacizumab as Maintenance Treatment of Platinum-sensitive Relapsed Epithelial Ovarian Cancer

A Phase 3 study testing Torvutatug samrotecan and Bevacizumab in people with Platinum-sensitive Relapsed Epithelial Ovarian Cancer and Platinum-sensitive Relapsed Fallopian Tube Cancer, run by AstraZeneca at 124 sites in 13 countries.

Recruiting

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

Sites and contacts

Official record

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Trial summary

The purpose of this study is to measure the efficacy and safety of torvutatug samrotecan (torvu-sam) with or without bevacizumab compared to standard of care (SoC) as maintenance treatment in participants with platinum-sensitive relapsed ovarian cancer (PSR OC) Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Platinum-sensitive Relapsed Epithelial Ovarian Cancer, Platinum-sensitive Relapsed Fallopian Tube Cancer, Platinum-sensitive Relapsed Primary Peritoneal 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: 600 participants
Where: 124 sitesin 13 countries
Study dates: 24 Sep 2026to 30 Oct 2031
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 histology of high-grade epithelial serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer.
Provision of an archival FFPE tumour sample
Participants who received at least one, and no more than 2 lines of prior systemic anticancer therapy.
Participants with radiologically confirmed disease relapse ≥ 6 months after their last platinum chemotherapy infusion in the previous line of treatment
Participants who received 4-6 cycles of PBC during the induction phase of their current line of treatment.
Participants assigned to bevacizumab must have received a minimum of 3 cycles of bevacizumab with 3 cycles of PBC prior to randomisation.
Participants with non-progressive disease upon completion of PBC in their current line of treatment.
Participants with documented BRCA mutation 1/2 must have received prior PARP inhibitor (unless ineligible due to contraindications, precautions, or intolerance).

Who cannot join

Participants with tumours of non-epithelial origin, borderline tumours, clear cell OC, mucinous OC, carcinosarcoma, or low-grade epithelial tumours.
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 (not applicable if not receiving bevacizumab)
Participants with evidence of active or ongoing bowel obstruction (not applicable if not receiving bevacizumab)
Participants with prior exposure to any FRα-targeted therapy, including MIRV, or any TOP1i Antibody-drug Conjugate (ADC)

Trial locations and contacts

124 sites in 13 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

124 sites in 13 countries

United States26 sites, 20 recruiting

Research Site
Albany, New York, 12206
Not yet recruiting
Research Site
Anchorage, Alaska, 99508
Not yet recruiting
Research Site
Ann Arbor, Michigan, 48109
Not yet recruiting
Research Site
Bay Shore, New York, 11706
Withdrawn
Research Site
Buffalo, New York, 14263
Not yet recruiting
Research Site
Cleveland, Ohio, 44111
Not yet recruiting
Research Site
Cleveland, Ohio, 44195
Not yet recruiting
Research Site
Columbia, Maryland, 21044
Not yet recruiting
Research Site
Columbus, Ohio, 43210
Withdrawn
Research Site
Detroit, Michigan, 48201
Not yet recruiting
Research Site
Greenlawn, New York, 11740
Withdrawn
Research Site
Houston, Texas, 77030
Not yet recruiting
Research Site
Indianapolis, Indiana, 46260
Not yet recruiting
Research Site
Mayfield Heights, Ohio, 44124
Not yet recruiting
Research Site
Miami, Florida, 33133
Not yet recruiting
Research Site
Morgantown, West Virginia, 26506
Not yet recruiting
Research Site
New Hyde Park, New York, 11042
Withdrawn
Research Site
New York, New York, 10011
Not yet recruiting
Research Site
New York, New York, 10029
Not yet recruiting
Research Site
Norfolk, Virginia, 23502
Not yet recruiting
Research Site
Oklahoma City, Oklahoma, 73104
Withdrawn
Research Site
Philadelphia, Pennsylvania, 19107
Not yet recruiting
Research Site
Rego Park, New York, 11374
Withdrawn
Research Site
Salt Lake City, Utah, 84112
Not yet recruiting
Research Site
Shreveport, Louisiana, 71103
Not yet recruiting
Research Site
Willow Grove, Pennsylvania, 19090
Not yet recruiting

Other trials in United States

Japan18 sites, 18 recruiting

Research Site
Chiba, 260-8677
Not yet recruiting
Research Site
Fukuoka, 812-8582
Not yet recruiting
Research Site
Fukushima, 960-1295
Not yet recruiting
Research Site
Gifu, 501-1194
Not yet recruiting
Research Site
Hidaka-shi, 350-1298
Not yet recruiting
Research Site
Ichihara, 299-0111
Not yet recruiting
Research Site
Kagoshima, 890-8520
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
Natori-shi, 981-1293
Not yet recruiting
Research Site
Sagamihara-shi, 252-0375
Not yet recruiting
Research Site
Shinjuku-ku, 160-0023
Not yet recruiting
Research Site
Suita-shi, 565-0871
Not yet recruiting
Research Site
Toyoake-shi, 470-1192
Not yet recruiting
Research Site
Yokohama, 236-0004
Not yet recruiting

Other trials in Japan

Germany17 sites, 17 recruiting

Research Site
Bad Homburg, 61352
Not yet recruiting
Research Site
Bonn, 53127
Not yet recruiting
Research Site
Brandenburg, 14770
Not yet recruiting
Research Site
Dresden, 01307
Not yet recruiting
Research Site
Düsseldorf, 40225
Not yet recruiting
Research Site
Essen, 45136
Not yet recruiting
Research Site
Gütersloh, 33332
Not yet recruiting
Research Site
Halle, 06120
Not yet recruiting
Research Site
Hamburg, 20246
Not yet recruiting
Research Site
Homburg, 66421
Not yet recruiting
Research Site
Kassel, 34125
Not yet recruiting
Research Site
Mainz, 55131
Not yet recruiting
Research Site
Mannheim, 68167
Not yet recruiting
Research Site
Münster, 48149
Not yet recruiting
Research Site
Schweinfurt, 97422
Not yet recruiting
Research Site
Wiesbaden, 65189
Not yet recruiting
Research Site
Wuppertal, 42283
Not yet recruiting

Other trials in Germany

China12 sites, 11 recruiting

Research Site
Beijing, 100210
Not yet recruiting
Research Site
Chengdu, 610041
Not yet recruiting
Research Site
Chengdu, 610066
Not yet recruiting
Research Site
Guangdong Province, 510060
Not yet recruiting
Research Site
Guangzhou, 510060
Not yet recruiting
Research Site
Hangzhou, 310006
Not yet recruiting
Research Site
Hangzhou, 310022
Not yet recruiting
Research Site
Nanchang, 330000
Not yet recruiting
Research Site
Wuhan, 430030
Withdrawn
Research Site
Wuhan, 430030
Not yet recruiting
Research Site
Wuhan, 430048
Not yet recruiting
Research Site
Zhengzhou, 450008
Not yet recruiting

Other trials in China

India9 sites, 8 recruiting

Research Site
Ahmedabad, 380060
Not yet recruiting
Research Site
Bangalore, 560004
Not yet recruiting
Research Site
Gūrgaon, 122002
Not yet recruiting
Research Site
Kottayam, 686008
Not yet recruiting
Research Site
Madurai, 625107
Not yet recruiting
Research Site
Nashik, 422 009
Withdrawn
Research Site
Nashik, 422002
Not yet recruiting
Research Site
New Delhi, 11029
Not yet recruiting
Research Site
Vadodara, 391760
Not yet recruiting

Other trials in India

Brazil7 sites, 7 recruiting

Research Site
Porto Alegre, 90035903
Not yet recruiting
Research Site
São Caetano do Sul, 09541-270
Not yet recruiting
Research Site
São José do Rio Preto, 15090-000
Not yet recruiting
Research Site
São José dos Campos, 12210-030
Not yet recruiting
Research Site
São Paulo, 01327-001
Not yet recruiting
Research Site
Teresina, 64049-200
Not yet recruiting
Research Site
Vitória, 29043-260
Not yet recruiting

Other trials in Brazil

Italy7 sites, 7 recruiting

Research Site
Milan, 20121
Not yet recruiting
Research Site
Milan, 20159
Not yet recruiting
Research Site
Monza, 20090
Not yet recruiting
Research Site
Naples, 80131
Not yet recruiting
Research Site
Rome, 00168
Not yet recruiting
Research Site
Torino, 10128
Not yet recruiting
Research Site
Treviso, 31100
Not yet recruiting

Other trials in Italy

Spain6 sites, 6 recruiting

Research Site
A Coruña, 15009
Not yet recruiting
Research Site
Barakaldo, 48903
Not yet recruiting
Research Site
Barcelona, 8035
Not yet recruiting
Research Site
Granollers, 08400
Not yet recruiting
Research Site
Madrid, 28033
Not yet recruiting
Research Site
Madrid, 28040
Not yet recruiting

Other trials in Spain

South Korea5 sites, 5 recruiting

Research Site
Goyang-si, 10408
Not yet recruiting
Research Site
Seoul, 03080
Not yet recruiting
Research Site
Seoul, 03722
Not yet recruiting
Research Site
Seoul, 135-710
Recruiting
Research Site
Seoul, 5505
Not yet recruiting

Other trials in South Korea

Taiwan5 sites, 5 recruiting

Research Site
Kaohsiung City, 81362
Not yet recruiting
Research Site
Taichung, 40447
Not yet recruiting
Research Site
Taichung, 40705
Recruiting
Research Site
Tainan, 70403
Recruiting
Research Site
Taipei, 10449
Not yet recruiting

Other trials in Taiwan

Thailand5 sites, 5 recruiting

Research Site
Bangkok, 10210
Not yet recruiting
Research Site
Bangkok, 10330
Not yet recruiting
Research Site
Bangkok, 10700
Not yet recruiting
Research Site
Hat Yai, 90110
Not yet recruiting
Research Site
Muang, 50200
Not yet recruiting

Other trials in Thailand

Australia4 sites, 4 recruiting

Research Site
Auchenflower, 4066
Not yet recruiting
Research Site
Blacktown, 2148
Not yet recruiting
Research Site
Clayton, 3168
Not yet recruiting
Research Site
Liverpool, 2170
Not yet recruiting

Other trials in Australia

Canada3 sites, 3 recruiting

Research Site
Abbotsford British Columbia, British Columbia, V2S0C2
Not yet recruiting
Research Site
Montreal, Quebec, H2X 0A9
Not yet recruiting
Research Site
Montreal, Quebec, H3A 1A1
Not yet recruiting

Other trials in Canada

About this study

Official title: A Randomised, Open-label, Phase III Study of Torvutatug Samrotecan With or Without Bevacizumab Versus Standard of Care as Second- or Third-Line Maintenance Treatment in Participants With Platinum-sensitive Relapsed Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (TREVI-OC-03)

Conditions: Platinum-sensitive Relapsed Epithelial Ovarian Cancer, Platinum-sensitive Relapsed Fallopian Tube Cancer, Platinum-sensitive Relapsed Primary Peritoneal Cancer
Being tested: Torvutatug samrotecan, Bevacizumab
Keywords: Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Platinum-sensitive Relapsed, Torvutatug samrotecan, AZD5335, Bevacizumab, Maintenance Treatment, Folate receptor alpha, Epithelial Ovarian Cancer, Torvu-sam, Trevi-OC-03, Folate receptor alpha antibody-drug
Medical subject headings: Ovarian Neoplasms, Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

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

Torvutatug samrotecanDrug
Also called AZD5335
FRa targeting antibody drug conjugate Topoisomerase I inhibitor
BevacizumabDrug
Monoclonal antibody inhibitor of Vascular Endothelial Growth Factor

Study groups in NCT07816666
Study group	Role	What they receive
Torvutatug samrotecan monotherapy or in combination with bevacizumab	Experimental	Torvutatug samrotecan monotherapy intravenous (IV) or Torvutatug samrotecan IV with bevacizumab IV. Receives: Drug: Torvutatug samrotecan; Drug: Bevacizumab
Observation or bevacizumab	Active comparator	Observation or 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 time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review, or death due to any cause.
Measured: Up to approximately 5 years

Secondary outcomes (6)

Overall Survival (OS)
OS is defined as time from randomisation until the date of death due to any cause.
Measured: Up to approximately 5 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 5 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 5 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 5 years

Timeline

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

24 Sep 202630 Oct 2031

First posted14 Sep 2026
Study start24 Sep 2026
Primary completion29 Sep 2028 (estimated)
Study completion30 Oct 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Platinum-sensitive Relapsed 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: None (open label)
Enrolment: 600 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07816666
Sponsor's protocol ID: D8992C00001
Other IDs: 2026-526776-23-00
Acronym: TREVI-OC-03
Status last verified: Oct 2026
First submitted: 7 Sep 2026
Last updated: 16 Oct 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.