Treatment
This trial consists of two different treatment options:
- Mirvetuximab soravtansine + Bevacizumab
- Bevacizumab
Both Mirvetuximab soravtansine and Bevacizumab are administered intravenously every three weeks.
Patients are randomized to one of either treatment groups.
Mirvetuximab soravtansine is a antibody drug conjugate (ADC) targeted to the α-folate receptor (αFR). Confirmation of αFR positivity is done via the Ventana FOLR1 assay.
Treatment duration
The treatment can continue until disease progression, unacceptable toxicity or withdrawal of consent
Eligibility
Main inclusion criteria:
- ECOG performance 0 or 1
- Histology: High-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
- Archival tumor tissue block or slides, or must undergo a new biopsy for central FRα testing
- Only FRα-high (PS2+ ≥ 75%)
- Known germline or somatic BRCA status. Somatic and germline BRCA-positive patients must have received prior treatment with a PARPi in maintenance following first-line treatment.
- First platinum sensitive relapse (platinum-free interval >6m)
- 4-8 cycles of platinum-based triplet therapy in 2nd line
- Triplet must contain paclitaxel, gemcitabine, or pegylated liposomal doxorubicin
- Triplet must contain bevacizumab:
- At least 3 cycles of bevacizumab in combination with platinum-based chemotherapy
- If the number of cycles received is less than 6 due to toxicity, this must be documented and toxicity assessed as unlikely related to bevacizumab
- In case of interval secondary cytoreductive surgery, patients are permitted to have received only 2 cycles of bevacizumab if given in combination with the last 3 cycles of platinum-based triplet therapy in the second line.
- In case of secondary cytoreductive surgery before 2nd line platinum-based triplet therapy, patients must have received no fewer than 3 cycles of bevacizumab in combination with platinum-based chemotherapy
- Randomized no later than 8 weeks from the last dose of platinum-based triplet therapy in the 2nd line
- CR, PR, or SD, in the 2nd line
Main exclusion criteria:
- Histology: endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors containing any of the above histologies; or low-grade/borderline ovarian tumor
- >1 line of prior chemotherapy. Lines of prior anticancer therapy are counted with the following considerations:
- Neoadjuvant ± adjuvant therapies = 1 line of therapy
- Maintenance therapy (eg, bevacizumab, PARPi) = part of the preceding line of therapy (ie, not counted independently)
- Change due to toxicity = considered as the same line
- After completion of triplet therapy and prior to randomization: Patients who receive an intervening dose of bevacizumab after the last dose of triplet therapy before randomization
- > Grade 1 peripheral neuropathy per CTCAE
- Ocular problems: Patients with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and/or monocular vision
Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT05445778). Criteria might change during the course of the study due to amendments. Inclusion in the trial remains the responsibility of the principal investigator of the trial and will depend on patient eligibility and slot availability.
Contact
In case you feel your patient might be eligible for this trial or in case you want to have more information about this trial, please feel free to contact us via: lgog@uzleuven.be