Mirvetuximab soravtansine combined with bevacizumab or carboplatin for FRα‑positive ovarian cancer
A Phase 2, Open-Label, Randomized, Master Protocol Dose Optimization Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Mirvetuximab Soravtansine in Subjects With Ovarian Cancer
This Phase 2 trial tests whether giving intravenous mirvetuximab soravtansine with bevacizumab or carboplatin is safe and can change disease activity in adults with folate receptor alpha (FRα)–positive high‑grade ovarian, fallopian tube, or primary peritoneal cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | bevacizumab, mirvetuximab, chemotherapy |
| Locations | 10 sites (Kogarah, New South Wales and 9 other locations) |
| Trial ID | NCT07059845 on ClinicalTrials.gov |
What this trial studies
About 320 adults with medium or high FRα expression (by the Ventana FOLR1 assay) will be assigned to one of two substudies and into specific treatment arms. Substudy 1 compares two doses of mirvetuximab soravtansine plus bevacizumab versus bevacizumab alone in FIGO stage III/IV HRP patients, while substudy 2 gives two doses of mirvetuximab soravtansine with carboplatin followed by mirvetuximab soravtansine alone in platinum‑sensitive relapsed patients. Treatments are given intravenously and participants are monitored for adverse events and changes in disease activity. The trial enrolls at multiple international sites, including several Australian oncology centers.
Who should consider this trial
Good fit: Ideal candidates are adults with high‑grade ovarian (or fallopian tube/primary peritoneal) cancer who are FRα‑positive by Ventana FOLR1, have ECOG performance status 0–1, and either are newly diagnosed FIGO stage III/IV HRP (substudy 1) or have platinum‑sensitive relapse after 1–2 prior platinum regimens (substudy 2).
Not a fit: Patients who are FRα‑negative, have ECOG ≥2, are platinum‑resistant, or do not meet the substudy‑specific criteria (for example HRD‑positive frontline disease) are unlikely to benefit from these treatment combinations.
Why it matters
Potential benefit: If successful, these combinations could provide a more effective targeted treatment option with manageable side effects for FRα‑positive ovarian cancer patients.
How similar studies have performed: Mirvetuximab soravtansine has shown single‑agent activity in other FRα‑positive ovarian cancer trials, but combining it with bevacizumab or carboplatin is still being tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Substudy 1 and 2: Confirmed high or medium folate receptor alpha (FRa) expression by Ventana folate receptor 1 (FOLR1) Assay. * Substudy 1 and 2: Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1. * Substudy 1: Participants must have a confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) Stage III or IV high-grade serous ovarian, primary peritoneal, or fallopian tube cancer. * Substudy 1: Tumor must be confirmed HRD test negative (HRP), determined by a local homologous recombination deficient (HRD) test. * Substudy 2: Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer. * Substudy 2: Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy. * Substudy 2: Participants must have platinum-sensitive disease defined as radiographic progression greater than 6 months from the last dose of platinum-based chemotherapy. * Substudy 2: Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline. Exclusion Criteria: * Substudy 1: Participants with progressive disease (PD) while on triplet therapy or after the first day of their last triplet therapy cycle and before randomization. * Substudy 1: Participants who receive an intervening dose of bevacizumab after the first day of their last triplet therapy cycle and before randomization. * Substudy 1: Participants who received prior treatment with mirvetuximab soravtansine, any FRα-targeting agent, or any investigational agent. * Substudy 2: More than 2 prior lines of chemotherapy. Lines of prior anticancer therapy are counted with the following considerations: * Neoadjuvant +/- adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens. * Maintenance therapy (e.g., bevacizumab, PARP inhibitor) will be considered part of the preceding line of therapy (i.e., not counted independently). * If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the proceeding line of therapy * Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen) * Substudy 2: Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents.
Where this trial is running
Kogarah, New South Wales and 9 other locations
- St. George Private Hospital /ID# 276570 — Kogarah, New South Wales, Australia (Recruiting)
- Icon Cancer Centre Wesley /ID# 277199 — Auchenflower, Queensland, Australia (Recruiting)
- Burnside War Memorial Hospital /ID# 277602 — Adelaide, South Australia, Australia (Recruiting)
- Icon Cancer Centre Hobart /ID# 277688 — Hobart, Tasmania, Australia (Recruiting)
- Monash Health - Monash Medical Centre /ID# 276984 — Clayton, Victoria, Australia (Recruiting)
- Austin Hospital /ID# 276534 — Melbourne, Victoria, Australia (Recruiting)
- Seoul National University Hospital /ID# 276182 — Seoul, Seoul Teugbyeolsi, South Korea (Recruiting)
- Yonsei University Health System Severance Hospital /ID# 276266 — Seoul, Seoul Teugbyeolsi, South Korea (Recruiting)
- Samsung Medical Center /ID# 276261 — Seoul, Seoul Teugbyeolsi, South Korea (Recruiting)
- Korea University Guro Hospital /ID# 276194 — Seoul, Seoul Teugbyeolsi, South Korea (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.