600 Participants NeededMy employer runs this trial

Torvutatug Samrotecan ± Bevacizumab for Ovarian Cancer

(TREVI-OC-03 Trial)

Recruiting at 101 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Female
Trial Phase: Phase 3
Sponsor: AstraZeneca
Must be taking: Bevacizumab
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?

This trial tests a new treatment for individuals with ovarian cancer that has recurred after responding to platinum-based chemotherapy. It evaluates the effectiveness and safety of the drug torvutatug samrotecan, alone or with bevacizumab, compared to standard treatments. The trial targets individuals whose cancer returned at least six months after their last platinum chemotherapy and who have undergone up to two previous cancer treatments. Participants must have a specific type of ovarian cancer and must have completed recent chemotherapy without disease progression. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that torvutatug samrotecan is generally well-tolerated by patients. Earlier research found that most participants experienced some side effects, but these were usually manageable. For example, many patients had treatment-related side effects, but they were not severe in most cases.

When combined with bevacizumab, torvutatug samrotecan maintains a similar safety profile. Bevacizumab, a drug often used in cancer treatment, has well-known and manageable side effects.

This trial is in a late stage, having already passed earlier safety-focused trials. So far, the data suggests that while some side effects are common, they are usually not severe. This is encouraging for those considering joining the trial, as it suggests the treatment is relatively safe for humans.12345

Why are researchers excited about this trial's treatments?

Most treatments for ovarian cancer, like chemotherapy and targeted therapies, work by attacking rapidly dividing cells or targeting specific proteins on cancer cells. But torvutatug samrotecan is unique because it combines a new mechanism with a targeted approach, acting not only on the cancer cells but also enhancing the immune response against the tumor. This treatment is particularly exciting because it can be used alone or in combination with bevacizumab, an established drug that inhibits blood vessel growth in tumors, potentially improving outcomes. Researchers are hopeful that this dual strategy might offer better control over the disease with fewer side effects than existing options.

What evidence suggests that this trial's treatments could be effective for ovarian cancer?

Research has shown that the drug torvutatug samrotecan may help treat ovarian cancer. In studies, it benefited 24.4% of patients with advanced ovarian cancer that didn't respond to other treatments. While it can delay cancer progression, it does not extend overall survival. In this trial, some participants will receive torvutatug samrotecan either as monotherapy or combined with bevacizumab. Bevacizumab, a drug that slows cancer progression, might extend the time before the cancer worsens when used with torvutatug samrotecan. Experts agree that combining bevacizumab with other ovarian cancer treatments can significantly delay cancer progression and improve survival.23456

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive torvutatug samrotecan with or without bevacizumab as maintenance treatment

Up to approximately 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 5 years

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+

Citations

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The Phase III TREVI-OC-01 trial (NCT07218809) will investigate whether AZD5335 improves outcomes in patients with platinum-resistant epithelial ovarian cancer ...

Torvutatug Samrotecan With or Without Bevacizumab as ...

The purpose of this study is to measure the efficacy and safety of torvutatug samrotecan (torvu-sam) with or without bevacizumab compared to ...