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Torvutatug Samrotecan ± Bevacizumab for Ovarian Cancer

(TREVI-OC-03 Trial)

Not yet recruiting at 69 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Female
Trial Phase: Phase 3
Sponsor: AstraZeneca
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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)

Are You a Good Fit for This Trial?

This trial is for people with ovarian or fallopian tube cancer that has come back after responding to platinum-based chemotherapy. Participants should be in generally good health and able to carry out daily activities.

Inclusion Criteria

I have completed at least 6 cycles of platinum-based chemotherapy.
My disease has not worsened after finishing my current chemotherapy.
I have a BRCA mutation and have tried a PARP inhibitor or could not take it for medical reasons.
See 5 more

Exclusion Criteria

I do not have any non-healing wounds, active ulcers, or bone fractures.
My tumor is not a high-grade epithelial ovarian cancer.
I do not have an active or ongoing bowel obstruction.
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • Bevacizumab
  • Torvutatug samrotecan

Trial Overview

The study compares the effectiveness and safety of a new drug, torvutatug samrotecan, given alone or with bevacizumab, versus standard maintenance treatments for patients whose ovarian cancer returned but still responds to platinum chemo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Torvutatug samrotecan monotherapy or in combination with bevacizumabExperimental Treatment2 Interventions
Group II: Observation or bevacizumabActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Collaborator

Trials
41
Recruited
19,200+

Ventana Medical Systems, Inc

Collaborator

Trials
1
Recruited
240+

GOG Foundation

Collaborator

Trials
48
Recruited
18,500+

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