Torvutatug Samrotecan + Bevacizumab for Ovarian Cancer
(TREVI-OC-02 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for individuals with advanced ovarian cancer. It compares the effects of a drug combination, Torvutatug samrotecan (an experimental treatment) plus bevacizumab, against bevacizumab alone. The goal is to determine if the combination is safer and more effective as a first maintenance treatment. Individuals who have recently completed chemotherapy for stage III or IV ovarian, fallopian tube, or primary peritoneal cancer, and are not BRCA positive, might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that bevacizumab is generally well-tolerated by patients with ovarian cancer. In one study, about six out of 13 patients showed a partial response to the treatment, indicating that many experience manageable side effects. Another study found that even older patients can use bevacizumab safely, suggesting its suitability for a wide range of ages.
Regarding torvutatug samrotecan, specific information about its safety with bevacizumab remains limited. However, advanced trials are testing the combination, indicating that earlier tests likely deemed it safe enough for further study. This ongoing research suggests that any side effects are probably manageable, but more detailed results will provide a clearer picture of its safety as more data becomes available.12345Why do researchers think this study treatment might be promising for ovarian cancer?
Torvutatug samrotecan is unique because it offers a novel approach to treating ovarian cancer by combining with Bevacizumab, a known anti-cancer agent. Unlike most treatments for ovarian cancer that primarily target the blood supply to tumors, Torvutatug samrotecan introduces a new mechanism by directly attacking cancer cells through its innovative chemotherapy compound. Researchers are excited about this combination as it has the potential to enhance the effectiveness of Bevacizumab, potentially leading to better outcomes for patients.
What evidence suggests that this trial's treatments could be effective for ovarian cancer?
Research has shown that bevacizumab, a drug commonly used in cancer treatment, can slow ovarian cancer by cutting off the blood supply to tumors. In this trial, some participants will receive bevacizumab alone, while others will receive a combination of bevacizumab and torvutatug samrotecan. Torvutatug samrotecan is a newer drug, and although limited data exists, early studies suggest it targets cancer cells directly. This combination might enhance bevacizumab's effectiveness. Using these two treatments together aims to improve outcomes by attacking the cancer in two ways: stopping its blood supply and directly killing cancer cells. This two-pronged approach holds promise for people with advanced ovarian cancer.678910
Are You a Good Fit for This Trial?
This trial is for adults with advanced ovarian, fallopian tube, or primary peritoneal cancer that does not have HRD (homologous recombination deficiency). Participants should have completed initial treatment and be healthy enough to continue maintenance therapy.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 in combination with Bevacizumab or Bevacizumab monotherapy 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 two treatments as first-line maintenance: one group receives both torvutatug samrotecan and bevacizumab, while the other gets only bevacizumab. Patients are randomly assigned to each group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Torvutatug samrotecan IV (intravenous) + Bevacizumab IV
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
GOG Foundation
Collaborator
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Collaborator
Citations
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clinical-trials-search.canada.ca
clinical-trials-search.canada.ca/en/clinical-trial/503891-fallopian-tube-cancer-epithelial-ovarian-cancer-primary-peritoneal-cancer503891-FALLOPIAN TUBE CANCER,PRIMARY ...
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Homologous Recombination Deficiency (HRD) Negative Advanced Epithelial ...
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