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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Sarasota Memorial Hospital /ID# 269526
  Sarasota, Florida, United States Recruiting
• US Oncology Research Investigational Products Center /ID# 278746
  Irving, Texas, United States Recruiting
• Cliniques Universitaires UCL Saint-Luc /ID# 269368
  Brussels, Brussels Capital, Belgium Recruiting
• Universitair Ziekenhuis Leuven /ID# 269370
  Leuven, Vlaams-Brabant, Belgium Recruiting
• Princess Margaret Cancer Centre /ID# 269390
  Toronto, Ontario, Canada Recruiting
• CHUM - Centre hospitalier de l'Universite de Montréal /ID# 269387
  Montreal, Quebec, Canada Recruiting

+214 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.