FLORENZA (substudy 1)

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

Planned
Grade
High grade
Prior lines
Frontline, 1
Biomarkers
⍺FR
Histology
Serous
Phase
II
IMP
Mirvetuximab
principal investigator
Prof. Dr. Toon Van Gorp

Treatment

  • Mirvetuximab + bevacizumab versus bevacizumab alone (randomization 2:1).
  • Mirvetuximab is given IV every 3 weeks.

 

Treatment duration

The treatment is given as maintenance therapy and up to 16 cycles can be given or until disease progression, unacceptable toxicity or withdrawal of consent.

Eligibility

Main inclusion criteria:

  • Confirmed high or medium folate receptor alpha (FRa) expression by Ventana folate receptor 1 (FOLR1) Assay
  • Participants must have a confirmed diagnosis of FIGO Stage III or IV high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
  • Tumor must be confirmed HRD test negative (HRP), determined by a local homologous recombination deficient (HRD) test

 

Main exclusion criteria:

  • Participants with progressive disease (PD) while on triplet therapy or after the first day of their last triplet therapy cycle and before randomization

Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT07059845). 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