> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/torvutatug-samrotecan-plus-bevacizumab-as-first-line-5eb0a1cc-25f7-4e21-abd1-9fef15f1a03a > Record changed: 2026-11-04 # Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Homologous Recombination Deficiency (HRD) Negative Advanced Epithelial Ovarian Cancer NCT07851025 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) Participants 950 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) Start date 2026-09-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) Number of sites 186 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) ## Title and summary **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 Homologous Recombination Deficient (HRD) negative advanced ovarian cancer. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) **Acronym** TREVI-OC-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) **Short title** Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Homologous Recombination Deficiency (HRD) Negative Advanced Epithelial Ovarian Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) **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 Homologous Recombination Deficiency (HRD) Negative Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (TREVI-OC-02) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) ## Dates **Completion date** 2033-08-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) **First posted** 2026-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) **Registry last updated** 2026-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) **Primary completion date** 2030-06-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) **Start date** 2026-09-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) ## Size and sites **Participants** 950 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) **Planned participants** 950 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) **Number of sites** 186 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) ## Identifiers **Registry ID** NCT07851025 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) **ClinicalTrials.gov ID** NCT07851025 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Single masking **Masking description** Open label **Masked roles** Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) ## Outcomes ### Primary outcomes 1. Progression Free Survival (PFS) Timeframe: 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. ### Secondary outcomes 1. Overall Survival (OS) Timeframe: up to approximately 7 years OS is defined as the time from randomization until the date of death due to any cause. 2. Second progression free survival (PFS2) Timeframe: up to approximately 5 years 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. 3. Time to First Subsequent Therapy (TFST) Timeframe: up to approximately 7 years 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. 4. Time to Second Subsequent Therapy (TSST) Timeframe: up to approximately 7 years 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. 5. Health-related Quality of Life (HrQoL) Timeframe: up to approximately 5 years 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). 6. Number and percentage of participants with adverse events as graded by CTCAE v6 criteria Timeframe: up to approximately 7 years Adverse Event Incidence Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) ## Eligibility **Sex** Female **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria: - 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 - HRD negative tumour Key Exclusion Criteria: - Participants with tumours of non-epithelial origin, borderline tumours, 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 - 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) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) ## Sites - Research SiteTampa, United StatesNot yet recruiting - Research SiteBaltimore, United StatesNot yet recruiting - Research SiteBillings, United StatesNot yet recruiting - Research SiteCleveland, United StatesNot yet recruiting - Research SiteBuenos Aires, ArgentinaNot yet recruiting - Research SiteBuenos Aires, ArgentinaNot yet recruiting - Research SiteCapital Federal, ArgentinaNot yet recruiting - Research SiteCiudad de Buenos Aires, ArgentinaNot yet recruiting - Research SiteCiudad de Buenos Aires, ArgentinaNot yet recruiting - Research SiteCórdoba, ArgentinaNot yet recruiting - Research SiteCórdoba, ArgentinaNot yet recruiting - Research SiteCórdoba, ArgentinaNot yet recruiting - Research SiteRosario, ArgentinaNot yet recruiting - Research SiteSalta, ArgentinaNot yet recruiting - Research SiteSanta Fe, ArgentinaNot yet recruiting - Research SiteViedma, ArgentinaNot yet recruiting - Research SiteAuchenflower, AustraliaNot yet recruiting - Research SiteBenowa, AustraliaNot yet recruiting - Research SiteHobart, AustraliaNot yet recruiting - Research SiteKingswood, AustraliaNot yet recruiting - Research SiteNedlands, AustraliaNot yet recruiting - Research SitePort Macquarie, AustraliaNot yet recruiting - Research SiteRandwick, AustraliaNot yet recruiting - Research SiteRichmond, AustraliaNot yet recruiting - Research SiteToorak Gardens, AustraliaNot yet recruiting And 161 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) ## References ### Other registry identifiers (4) - 2026-526895-22-00 - 180099 - GOG-3149 - ENGOT-ov110 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07851025) ## Related records ### Drugs (2) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Torvutatug samrotecan](https://trialight.com/data/asset/torvutatug-samrotecan-1e68c30b-46d4-51d4-9f13-7bffdbe4f1ac.md) ### Collaborators (2) - European Network of Gynaecological Oncological Trial Groups (ENGOT) - GOG Foundation ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (2) - [Fallopian tube neoplasm](https://trialight.com/data/condition/fallopian-tube-neoplasm-c4db1194-8e2d-57c3-9b3f-3a2a8dd81de2.md) - [Ovarian carcinoma](https://trialight.com/data/condition/ovarian-carcinoma-e5ec8fdc-01ec-5cd9-9507-107d23d3a30b.md) Primary condition ### Targets (1) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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