Torvutatug Samrotecan With or Without Bevacizumab as Maintenance Treatment of Platinum-sensitive Relapsed Epithelial Ovarian Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT07816666
This study evaluates the efficacy and safety of torvutatug samrotecan, a FRa-targeting antibody drug conjugate, with or without bevacizumab, a VEGF inhibitor, in PSR OC patients. Eligible participants have high-grade epithelial ovarian cancer, received 1-2 prior therapies, and show non-progressive disease post-platinum chemotherapy. BRCA mutation carriers must have prior PARP inhibitor exposure.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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)
Eligibility Criteria
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 4-6 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)
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 99508 | Anchorage | Alaska |
| Research Site | 33133 | Miami | Florida |
| Research Site | 46260 | Indianapolis | Indiana |
| Research Site | 71103 | Shreveport | Louisiana |
| Research Site | 21044 | Columbia | Maryland |
| Research Site | 48109 | Ann Arbor | Michigan |
| Research Site | 48201 | Detroit | Michigan |
| Research Site | 12206 | Albany | New York |
| Research Site | 11706 | Bay Shore | New York |
| Research Site | 14263 | Buffalo | New York |
Get This Program In Your Inbox
You can sign up and apply your patients for this program.
