Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Homologous Recombination Deficiency (HRD) Negative Advanced Epithelial Ovarian Cancer (TREVI-OC-02)

At a glance

Phase

Phase 3

Study type

Interventional

Sponsor

AstraZeneca

Enrolment target

950

Started

16 September 2026

Main results due (estimated)

18 June 2030

Study ends (estimated)

17 August 2033

Allocation

Randomized

Design

Parallel

Purpose

Treatment

Masking

Single (outcomes assessor)

Sites

186 · 10 in India

First posted

1 October 2026

Registry updated

1 October 2026

Open label

Can you take part?

• Aged 18 years and over.
• Women only.
• You need the condition being studied. Healthy volunteers are not accepted.

Age groups: adult, older adult.

These are the headline rules. Every study has a longer list, and whether you are eligible is decided by the research team at the site, 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)

What this study is about

In the sponsor’s own words, from the registry.

Keywords: Epithelial ovarian cancer · Fallopian tube cancer · Primary peritoneal cancer · Folate receptor alpha · Antibody-drug conjugate · TREVI-OC-02 · Torvutatug samrotecan · Torvu-sam · Homologous recombination deficiency (HRD) · HRD negative

What participants receive

• Experimental

  Torvutatug samrotecan + Bevacizumab

  Torvutatug samrotecan IV (intravenous) + Bevacizumab IV

  Drug: Torvutatug samrotecan · Drug: Bevacizumab

• Active comparator

  Bevacizumab

  Bevacizumab IV

  Drug: Bevacizumab

What the study measures

Who is running it

Lead sponsor

AstraZeneca

Sponsor type

Industry

Responsible party

The sponsor

Organisation

AstraZeneca

Collaborators

European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation

Data monitoring committee

Yes

US FDA-regulated drug

Yes

US FDA-regulated device

No

Sponsor's study ID

D8994C00001

Other IDs

2026-526895-22-00, GOG-3149, ENGOT-ov110, 180099

Study sites(186)

References and data sharing

Participant data shared

Yes

What is shared

Study protocol, Sap

When

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Access

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Where

https://vivli.org/

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.