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

NCT07851025
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
950
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Lead sponsor
AstraZeneca
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Start date
2026-09-16
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Number of sites
186
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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.
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Acronym
TREVI-OC-02
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Short title
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Homologous Recombination Deficiency (HRD) Negative Advanced Epithelial Ovarian Cancer
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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)
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2033-08-17
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First posted
2026-10-01
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Registry last updated
2026-10-01
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Primary completion date
2030-06-18
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Start date
2026-09-16
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Participants
950
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Participant count basis
Estimated
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Planned participants
950
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Number of sites
186
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
AstraZeneca
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07851025
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ClinicalTrials.gov ID
NCT07851025
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Single masking
Masking description
Open label
Masked roles
Outcome assessors
Sources for study design
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  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.

  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
clinicaltrials.gov

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
clinicaltrials.gov

  • 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
clinicaltrials.gov

  • 2026-526895-22-00
  • 180099
  • GOG-3149
  • ENGOT-ov110
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Collaborators (2)

Lead sponsors (1)

Conditions (2)

Targets (1)