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USClinicalTrials.govClinical trialPhase 3Recruiting

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

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Official record

Identifier
NCT07851025
Recruiting locations

countries

United StatesArgentinaAustraliaBrazilBulgariaCanadaChileChinaColombiaGermanyGreeceIndiaIsraelItalyJapanMalaysiaPeruPhilippinesSlovakiaSloveniaSouth KoreaSpainTaiwanThailand
Interventions studied
Torvutatug samrotecanBevacizumab
Lead sponsor
AstraZeneca
Target enrolment
950 participants
Study type
INTERVENTIONAL
Phase
Phase 3
Status
Recruiting
First posted
Oct 1, 2026
Last updated on the registry
Oct 1, 2026
Age
18 Years
Sex
FEMALE
Study contact
The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.
Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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)
Indexed under
Ovarian Cancer