Platinum-sensitive Relapsed Epithelial Ovarian Cancer, Platinum-sensitive Relapsed Fallopian Tube Cancer, Platinum-sensitive Relapsed Primary Peritoneal Cancer
Conditions
Keywords
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Platinum-sensitive Relapsed, Torvutatug samrotecan, AZD5335, Bevacizumab, Maintenance Treatment, Folate receptor alpha, Epithelial Ovarian Cancer, Torvu-sam, Trevi-OC-03, Folate receptor alpha antibody-drug
Brief summary
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)
Interventions
FRa targeting antibody drug conjugate Topoisomerase I inhibitor
DRUGBevacizumab
Monoclonal antibody inhibitor of Vascular Endothelial Growth Factor
Sponsors
AstraZeneca
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Ventana Medical Systems, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with confirmed histology of high-grade epithelial serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer. * Provision of an archival FFPE tumour sample * Participants who received at least one, and no more than 2 lines of prior systemic anticancer therapy. * Participants with radiologically confirmed disease relapse ≥ 6 months after their last platinum chemotherapy infusion in the previous line of treatment * Participants who received at least 6 cycles of PBC during the induction phase of their current line of treatment. * Participants assigned to bevacizumab must have received a minimum of 3 cycles of bevacizumab with 3 cycles of PBC prior to randomisation. * Participants with non-progressive disease upon completion of PBC in their current line of treatment. * Participants with documented BRCA mutation 1/2 must have received prior PARP inhibitor (unless ineligible due to contraindications, precautions, or intolerance).
Exclusion criteria
* Participants with tumours of non-epithelial origin, borderline tumours, clear cell OC, mucinous OC, carcinosarcoma, 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 (not applicable if not receiving bevacizumab) * Participants with evidence of active or ongoing bowel obstruction (not applicable if not receiving bevacizumab) * Participants with prior exposure to any FRα-targeted therapy, including MIRV, or any TOP1i Antibody-drug Conjugate (ADC)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Up to approximately 5 years | PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review, or death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to approximately 5 years | OS is defined as time from randomisation until the date of death due to any cause. |
| Second Progression-Free Survival (PFS2) | Up to approximately 5 years | PFS2 is defined as time from randomisation to the earliest of the progression event (following the initial investigator-assessed progression) after first subsequent therapy, or death. |
| Time to First Subsequent Therapy (TFST) | Up to approximately 5 years | TFST is defined as time from randomisation until the start date of the first subsequent anti-cancer therapy after discontinuation of randomised treatment, or death due to any cause. |
| Time to Second Subsequent Therapy (TSST) | Up to approximately 5 years | TSST is defined as time from randomisation until the start date of the second subsequent anti-cancer therapy after discontinuation of randomised treatment, or death due to any cause. |
| Health-related Quality of Life (HrQoL) | Up to approximately 5 years | Change from baseline and time to deterioration in global health status/quality of life (GHS/QoL), physical functioning (PF), and ovarian cancer symptoms (EORTC IL433). |
| Number and percentage of participants with adverse events as graded by CTCAE v6 criteria | Up to approximately 5 years | Adverse Event Incidence |
Countries
Australia, Brazil, Canada, China, Germany, India, Japan, South Korea, Taiwan, Thailand, United States
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed