Study on Mirvetuximab Soravtansine with Bevacizumab vs. Bevacizumab for Maintenance in Platinum-sensitive Ovarian, Fallopian Tube, or Peritoneal Cancer (GLORIOSA)

Sponsor: AbbVie

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05445778

Provider View

This clinical trial is testing whether adding the drug Mirvetuximab Soravtansine to Bevacizumab can improve treatment outcomes for patients with platinum-sensitive ovarian, fallopian tube, or peritoneal cancer that have high levels of a specific protein called folate receptor-alpha.

Patient Parameters

Program Overview

The GLORIOSA study is a Phase 3 trial conducted at multiple centers to evaluate the safety and effectiveness of Mirvetuximab Soravtansine as a maintenance treatment for patients with platinum-sensitive ovarian, primary peritoneal, or fallopian tube cancers that express high levels of folate receptor-alpha (FRα).

Description

Mirvetuximab Soravtansine (MIRV) is an experimental drug designed to target and kill cancer cells. It works by attaching to a protein called folate receptor alpha (FRα) found on certain tumor cells and delivering a cell-killing drug directly to them. This study is exploring its use as a maintenance therapy for patients with recurrent platinum-sensitive high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers that have high FRα expression. To participate, patients must have their FRα levels confirmed by a specific test called the Ventana FOLR1 Assay.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a good performance status, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have a confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.
  • Must provide a tumor sample for testing to confirm high levels of FRα.
  • Must have had BRCA genetic testing, and if positive, must have received prior treatment with a PARP inhibitor.
  • Cancer must have returned after one line of platinum-based chemotherapy and be sensitive to platinum, meaning it has not progressed for more than 6 months after the last treatment.
  • Must have completed a specific number of cycles of platinum-based chemotherapy with bevacizumab in the second line of treatment.
  • Must have achieved a complete response, partial response, or stable disease after second-line treatment.
  • Must have adequate blood counts and organ function.
  • Must agree to use effective contraception if of childbearing potential and have a negative pregnancy test before starting treatment.

Exclusion Criteria

  • Have certain types of ovarian cancer, such as endometrioid, clear cell, or mucinous.
  • Have had more than one line of chemotherapy before the current treatment.
  • Have disease progression while on or after platinum-based therapy.
  • Have received certain treatments like wide-field radiotherapy affecting bone marrow.
  • Have significant peripheral neuropathy or eye conditions.
  • Have active infections like hepatitis B, C, or HIV.
  • Have significant heart disease or recent stroke.
  • Have a history of severe lung disease or bowel obstruction.
  • Have significant protein in urine or history of severe blood clots.
  • Are not suitable for bevacizumab treatment.
  • Are pregnant or breastfeeding.
  • Have received prior treatment with MIRV or similar drugs.
  • Have untreated or symptomatic brain metastases.
  • Have had another cancer within the last 3 years, except for certain low-risk cancers.

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