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 (FLORENZA)

NCT07059845 Phase 2 RECRUITING

Ovarian cancer is a lethal disease with an estimated 310,000 new cases and 200,000 deaths experienced worldwide in 2020. The purpose of this study is to assess the adverse events and change in disease activity of mirvetuximab soravtansine with carboplatin, or bevacizumab (Bev), or bev alone in participants with ovarian cancer (OC). Participants must have confirmation of folate receptor alpha (FRa) positivity by the Ventana folate receptor 1 (FOLR1) Assay. Mirvetuximab Soravtansine (MIRV) is an investigational drug for the treatment of OC. Participants will be assigned to 1 of 2 substudies and further into groups called treatment arms. In substudy 1, arms A-C, participants will receive 1 of 2 doses of MIRV with Bev, or Bev alone. In substudy 2, arms D and E, participants will receive 1 of 2 doses of MIRV with carboplatin, followed by MIRV alone. Approximately 320 participants will be enrolled in the study at 100 sites around the world. Participants will receive intravenously (IV) infused MIRV with IV infused carboplatin, or IV infused Bev, or IV infused Bev alone. The total study duration will be approximately 40 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Details

Lead sponsor	AbbVie
Phase	Phase 2
Status	RECRUITING
Enrolment	320
Start date	2025-11-13
Completion	2029-01

Conditions

• Ovarian Cancer

Interventions

• Mirvetuximab Soravtansine
• Bevacizumab
• Carboplatin

Primary outcomes

• Substudy 1 and 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (any grade, Grade >= 3) — Up to Approximately 40 Months
  TEAEs defined as any adverse event (AE) with the onset after the first dose of study drug until 30 days after the last dose of the study drug.
• Substudy 1 and 2: Number of Participants with TEAEs Leading to Discontinuation — Up to Approximately 40 Months
  TEAEs defined as any adverse event (AE) with the onset after the first dose of study drug until 30 days after the last dose of the study drug.
• Substudy 1 and 2: Number of Participants with Ocular Adverse Events (AEs) (any grade, Grade >= 2) — Up to Approximately 40 Months
  An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
• Substudy 1 and 2: Overall Response (OR) as Assessed by the Investigator per RECIST v1.1 — Up to Approximately 40 Months
  OR is defined as achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• Substudy 1: Progression free survival (PFS) as Assessed by the Investigator per RECIST v1.1 — Up to Approximately 40 Months
  PFS is defined as the time from the date of randomization to the first occurrence of radiographic progression based on RECIST version 1.1 or death from any cause, whichever occurs first.

Countries

Australia, South Korea