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Treatment for platinum-sensitive ovarian, fallopian tube, or peritoneal cancer

Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FRα-high Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-based Chemotherapy Plus Bevacizumab

Phase 3 Interventional AbbVie · NCT05445778

This study is testing a new treatment called mirvetuximab Soravtansine to see if it helps people with certain types of ovarian cancer feel better when combined with another drug called Bevacizumab.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment520 (estimated)
Ages18 Years and up
SexFemale
SponsorAbbVie Industry-sponsored
Drugs / interventionsbevacizumab, chemotherapy, mirvetuximab
Locations264 sites (Mobile, Alabama and 263 other locations)
Trial IDNCT05445778 on ClinicalTrials.gov

What this trial studies

This Phase 3 multicenter, open-label study evaluates the safety and efficacy of mirvetuximab Soravtansine as maintenance therapy for patients with platinum-sensitive ovarian, primary peritoneal, or fallopian tube cancers that express high levels of folate receptor-alpha. The investigational drug, an antibody-drug conjugate, targets cancer cells by delivering a cytotoxic agent specifically to those expressing the folate receptor alpha protein. Participants must have confirmed high FRα expression and may need to provide tumor tissue for testing. The study compares the combination of mirvetuximab Soravtansine with Bevacizumab against Bevacizumab alone.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer that is platinum-sensitive and has high folate receptor-alpha expression.

Not a fit: Patients with low folate receptor-alpha expression or those who have not previously received treatment with a PARP inhibitor may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective maintenance therapy option for patients with specific types of ovarian cancer.

How similar studies have performed: Other studies have shown promise with antibody-drug conjugates in treating similar cancers, indicating a potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Adult women \>/=18 years old
2. Confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
3. Confirmed high FRα expression by regulatory-agency approved Ventana FOLR1 (FOLR1-2.1)
4. Relapsed disease after frontline (first-line) platinum-based chemotherapy and must be plantinum-sensitive
5. Willing and able to sign the informed consent form (ICF) and adhere to protocol requirements
6. Negative pregnancy test and willing to use highly effective contraceptive method(s) while on study medication and for at least 7 months after the last dose of MIRV and 6 months after the last dose of bevacizumab

Exclusion Criteria:

1. Endometrioid, clear cell, mucinous, or sarconmatous histology; mixed tumors containing any of the above or low grade/borderline ovarian tumor
2. More than one line of prior chemotherapy before current/planned triplet therapy
3. PD (progressive disease) while on or following platinum-based therapy
4. Prior or whole-pelvis or wide-field radiotherapy
5. \> Grade 1 peripheral neuropathy
6. History of or concurrent ocular disorders
7. Grade 4 thromboembolic events
8. Not appropriate for bevacizumab treatment
9. Requiring use of folate-containing supplements
10. Prior hypersensitivity to monoclonal antibodies
11. Pregnant or breatfeeding women
12. Received prior MIRV or other FRα-targeting agents
13. Untreated or symptomatic central nervous system metastases
14. History of other malignancy within 3 years prior to signing study consent

Where this trial is running

Mobile, Alabama and 263 other locations

+214 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ovarian CancerPeritoneal CancerFallopian Tube CancerPlatinum-sensitiveFolate-receptor alpha expressionAntibody-drug conjugateCancerOvarian Neoplasma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.