Torvutatug Samrotecan ± Bevacizumab for Ovarian Cancer
(TREVI-OC-03 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.12345Why 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive torvutatug samrotecan with or without bevacizumab as maintenance treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Torvutatug samrotecan monotherapy intravenous (IV) or Torvutatug samrotecan IV with bevacizumab IV.
Observation or bevacizumab IV.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
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
Ventana Medical Systems, Inc
Collaborator
GOG Foundation
Collaborator
Citations
What does the future hold for antibody-drug conjugate ...
T-DXd has proven to be effective even in low HER2 expression in advanced breast cancer, but efficacy data of HER2 low ovarian cancers is lacking.
torvutatug samrotecan (AZD5335) / AstraZeneca
Data from this trial will inform future monotherapy. Platinum resistant • Oncology • Ovarian Cancer … preliminary signs of efficacy. Dose optimisation is ...
3.
onclive.com
onclive.com/view/puxitatug-samrotecan-elicits-high-response-rate-in-select-endometrial-cancersPuxitatug Samrotecan Elicits High Response Rate in ...
produced a confirmed objective response rate (ORR) of 47.1% and a median progression-free survival (PFS) of 7.2 months in patients ・ climbed ...
Expert Second Opinion
Torvutatug samrotecan (AZD5335) A progression-free survival (PFS) benefit but not an overall survival (OS) benefit. Neither a PFS benefit nor an OS benefit 3. ...
5.
gynecologiconcology-online.net
gynecologiconcology-online.net/article/S0090-8258(26)00174-5/abstractTorvutatug samrotecan (AZD5335) vs mirvetuximab ...
The Phase III TREVI-OC-01 trial (NCT07218809) will investigate whether AZD5335 improves outcomes in patients with platinum-resistant epithelial ovarian cancer ...
6.
ctv.veeva.com
ctv.veeva.com/study/torvutatug-samrotecan-with-or-without-bevacizumab-as-maintenance-treatment-of-platinum-sensitive-relTorvutatug 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 ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.