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.
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
- 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 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
124 sites in 13 countries
United States26 sites, 20 recruiting
- Not yet recruiting
Research Site
Albany, New York, 12206
- Not yet recruiting
Research Site
Anchorage, Alaska, 99508
- Not yet recruiting
Research Site
Ann Arbor, Michigan, 48109
- Withdrawn
Research Site
Bay Shore, New York, 11706
- Not yet recruiting
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
- Withdrawn
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Columbus, Ohio, 43210
- Not yet recruiting
Research Site
Detroit, Michigan, 48201
- Withdrawn
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Greenlawn, New York, 11740
- Not yet recruiting
Research Site
Houston, Texas, 77030
- Not yet recruiting
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Indianapolis, Indiana, 46260
- Not yet recruiting
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Mayfield Heights, Ohio, 44124
- Not yet recruiting
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Miami, Florida, 33133
- Not yet recruiting
Research Site
Morgantown, West Virginia, 26506
- Withdrawn
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New Hyde Park, New York, 11042
- Not yet recruiting
Research Site
New York, New York, 10011
- Not yet recruiting
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New York, New York, 10029
- Not yet recruiting
Research Site
Norfolk, Virginia, 23502
- Withdrawn
Research Site
Oklahoma City, Oklahoma, 73104
- Not yet recruiting
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Philadelphia, Pennsylvania, 19107
- Withdrawn
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Rego Park, New York, 11374
- Not yet recruiting
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Salt Lake City, Utah, 84112
- Not yet recruiting
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Shreveport, Louisiana, 71103
- Not yet recruiting
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Willow Grove, Pennsylvania, 19090
Japan18 sites, 18 recruiting
- Not yet recruiting
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Chiba, 260-8677
- Not yet recruiting
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Fukuoka, 812-8582
- Not yet recruiting
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Fukushima, 960-1295
- Not yet recruiting
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Gifu, 501-1194
- Not yet recruiting
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Hidaka-shi, 350-1298
- Not yet recruiting
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Ichihara, 299-0111
- Not yet recruiting
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Kagoshima, 890-8520
- Not yet recruiting
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Kobe, 650-0047
- Not yet recruiting
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Kōtoku, 135-8550
- Not yet recruiting
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Kurume-shi, 830-0011
- Not yet recruiting
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Kyoto, 612-8555
- Not yet recruiting
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Minatoku, 105-8471
- Not yet recruiting
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Natori-shi, 981-1293
- Not yet recruiting
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Sagamihara-shi, 252-0375
- Not yet recruiting
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Shinjuku-ku, 160-0023
- Not yet recruiting
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Suita-shi, 565-0871
- Not yet recruiting
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Toyoake-shi, 470-1192
- Not yet recruiting
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Yokohama, 236-0004
Germany17 sites, 17 recruiting
- Not yet recruiting
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Bad Homburg, 61352
- Not yet recruiting
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Bonn, 53127
- Not yet recruiting
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Brandenburg, 14770
- Not yet recruiting
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Dresden, 01307
- Not yet recruiting
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Düsseldorf, 40225
- Not yet recruiting
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Essen, 45136
- Not yet recruiting
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Gütersloh, 33332
- Not yet recruiting
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Halle, 06120
- Not yet recruiting
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Hamburg, 20246
- Not yet recruiting
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Homburg, 66421
- Not yet recruiting
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Kassel, 34125
- Not yet recruiting
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Mainz, 55131
- Not yet recruiting
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Mannheim, 68167
- Not yet recruiting
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Münster, 48149
- Not yet recruiting
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Schweinfurt, 97422
- Not yet recruiting
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Wiesbaden, 65189
- Not yet recruiting
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Wuppertal, 42283
China12 sites, 11 recruiting
- Not yet recruiting
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Beijing, 100210
- Not yet recruiting
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Chengdu, 610041
- Not yet recruiting
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Chengdu, 610066
- Not yet recruiting
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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
- Withdrawn
Research Site
Wuhan, 430030
- Not yet recruiting
Research Site
Wuhan, 430030
- Not yet recruiting
Research Site
Wuhan, 430048
- Not yet recruiting
Research Site
Zhengzhou, 450008
India9 sites, 8 recruiting
- Not yet recruiting
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Ahmedabad, 380060
- Not yet recruiting
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Bangalore, 560004
- Not yet recruiting
Research Site
Gūrgaon, 122002
- Not yet recruiting
Research Site
Kottayam, 686008
- Not yet recruiting
Research Site
Madurai, 625107
- Withdrawn
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Nashik, 422 009
- Not yet recruiting
Research Site
Nashik, 422002
- Not yet recruiting
Research Site
New Delhi, 11029
- Not yet recruiting
Research Site
Vadodara, 391760
Brazil7 sites, 7 recruiting
- Not yet recruiting
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Porto Alegre, 90035903
- Not yet recruiting
Research Site
São Caetano do Sul, 09541-270
- Not yet recruiting
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São José do Rio Preto, 15090-000
- Not yet recruiting
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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
Italy7 sites, 7 recruiting
- Not yet recruiting
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Milan, 20121
- Not yet recruiting
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Milan, 20159
- Not yet recruiting
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Monza, 20090
- Not yet recruiting
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Naples, 80131
- Not yet recruiting
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Rome, 00168
- Not yet recruiting
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Torino, 10128
- Not yet recruiting
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Treviso, 31100
Spain6 sites, 6 recruiting
- Not yet recruiting
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A Coruña, 15009
- Not yet recruiting
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Barakaldo, 48903
- Not yet recruiting
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Barcelona, 8035
- Not yet recruiting
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Granollers, 08400
- Not yet recruiting
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Madrid, 28033
- Not yet recruiting
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Madrid, 28040
South Korea5 sites, 5 recruiting
- Not yet recruiting
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Goyang-si, 10408
- Not yet recruiting
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Seoul, 03080
- Not yet recruiting
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Seoul, 03722
- Recruiting
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Seoul, 135-710
- Not yet recruiting
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Seoul, 5505
Taiwan5 sites, 5 recruiting
- Not yet recruiting
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Kaohsiung City, 81362
- Not yet recruiting
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Taichung, 40447
- Recruiting
Research Site
Taichung, 40705
- Recruiting
Research Site
Tainan, 70403
- Not yet recruiting
Research Site
Taipei, 10449
Thailand5 sites, 5 recruiting
- Not yet recruiting
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Bangkok, 10210
- Not yet recruiting
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Bangkok, 10330
- Not yet recruiting
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Bangkok, 10700
- Not yet recruiting
Research Site
Hat Yai, 90110
- Not yet recruiting
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Muang, 50200
Australia4 sites, 4 recruiting
- Not yet recruiting
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Auchenflower, 4066
- Not yet recruiting
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Blacktown, 2148
- Not yet recruiting
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Clayton, 3168
- Not yet recruiting
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Liverpool, 2170
Canada3 sites, 3 recruiting
- Not yet recruiting
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Abbotsford British Columbia, British Columbia, V2S0C2
- Not yet recruiting
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Montreal, Quebec, H2X 0A9
- Not yet recruiting
Research Site
Montreal, Quebec, H3A 1A1
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)
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)
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT), Ventana Medical Systems, Inc
- Responsible party
- Sponsor
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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 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 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)
- ClinicalTrials.gov ID
- NCT07816666
- Acronym / sponsor ID
- TREVI-OC-03 / D8992C00001
- Conditions
- Platinum-sensitive Relapsed Epithelial Ovarian Cancer, Platinum-sensitive Relapsed Fallopian Tube Cancer, Platinum-sensitive Relapsed Primary Peritoneal Cancer
- Keywords
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Platinum-sensitive Relapsed, Torvutatug samrotecan, AZD5335, Bevacizumab, Maintenance Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT), Ventana Medical Systems, Inc
- Study start
- 24 Sep 2026 (actual)
- Primary completion
- 29 Sep 2028 (estimated)
- Study completion
- 30 Oct 2031 (estimated)
- First posted
- 14 Sep 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.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Torvutatug samrotecan monotherapy or in combination with bevacizumab | Experimental | Drug: Torvutatug samrotecan, Drug: BevacizumabTorvutatug samrotecan monotherapy intravenous (IV) or Torvutatug samrotecan IV with bevacizumab IV. |
| Observation or bevacizumab | Active comparator | Drug: BevacizumabObservation or bevacizumab IV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
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: AZD5335FRa targeting antibody drug conjugate Topoisomerase I inhibitor | Drug | Torvutatug samrotecan monotherapy or in combination with bevacizumab |
| BevacizumabMonoclonal antibody inhibitor of Vascular Endothelial Growth Factor | Drug | Observation or bevacizumab, Torvutatug samrotecan monotherapy or in combination with bevacizumab |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Up to approximately 5 years
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.
6 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 5 years
Second Progression-Free Survival (PFS2)
Time frame: Up to approximately 5 years
Time to First Subsequent Therapy (TFST)
Time frame: Up to approximately 5 years
Time to Second Subsequent Therapy (TSST)
Time frame: Up to approximately 5 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 5 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 16 Oct 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.
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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
124 sites in 13 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 Platinum-sensitive Relapsed Epithelial Ovarian Cancer and Platinum-sensitive Relapsed Fallopian Tube Cancer, run by AstraZeneca at 124 sites in 13 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 8 inclusion and 5 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 124 sites in United States, Japan, Germany, China, India and 8 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?
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 16 Oct 2026.