Study of Mirvetuximab Soravtansine in Combination With Bevacizumab, Carboplatin, Pegylated Liposomal Doxorubicin, Pembrolizumab, or Bevacizumab + Carboplatin in Participants With Folate Receptor Alpha (FRα) Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal, or Fallopian Tube Cancer

Study Identifier
IMGN853-0402
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English

Study Details

Medical Condition
  • Ovarian Cancer
  • Gynecologic Cancer - Other
  • Gynecologic Cancer - Fallopian Tube Cancer
  • Study Drug
  • Mirvetuximab soravtansine
  • Bevacizumab
  • Carboplatin
  • Pegylated Liposomal Doxorubicin
  • Pembrolizumab
  • Phase
    Phase 1/Phase 2
    Sex
    Female
    Age
    18+ years

    Protocol Summary

    This study comprises a Dose Escalation phase followed by a Dose Expansion phase. Dose Escalation part of the study will assess the safety and tolerability and determine the maximum tolerated dose (MTD) as the recommended Phase 2 (RP2D) dose for each regimen. Participants will be assigned to one of the 4 regimens in Dose Escalation phase: Regimen A: mirvetuximab soravtansine administered with bevacizumab; Regimen B: mirvetuximab soravtansine administered with carboplatin; Regimen C: mirvetuximab soravtansine administered with pegylated liposomal doxorubicin; or Regimen D: mirvetuximab soravtansine administered with pembrolizumab. Dose Expansion of the study will further assess safety, tolerability and preliminary anti-tumor activity of mirvetuximab soravtansine. A Dose Expansion phase is planned for Regimen A and Regimen D and will open pending Sponsor decision; participants enrolled in the Dose Expansion phase will receive study treatment at the MTD or RP2D determined during Dose Escalation. For Regimen A, participants in the Dose Expansion phase may be enrolled according to prior exposure to bevacizumab into 3 Dose Expansion Cohorts as follows: 1) Dose Expansion Cohort 1: bevacizumab naïve; 2) Dose Expansion Cohort 2: bevacizumab pretreated; and 3) Dose Expansion Cohort 3: one to three prior treatments, one of which could have been bevacizumab. A triplet Regimen (Regimen E: mirvetuximab soravtansine + bevacizumab + carboplatin) will be opened to evaluate the safety and tolerability and to assess any early signs of activity in participants dosed with the combination regimen. All mirvetuximab soravtansine doses were calculated according to adjusted ideal body weight.

    Study Locations

    Location
    Status
    Location
    University of California at Los Angeles
    Los Angeles, California, United States
    Status
    Not applicable
    Location
    Massachusetts General Hospital
    Boston, Massachusetts, United States, 02114
    Status
    Not applicable
    Location
    Dana-Farber Cancer Institute
    Boston, Massachusetts, United States, 02215
    Status
    Not applicable
    Location
    City of Hope
    Reno, Nevada, United States
    Status
    Not applicable
    Location
    The Ohio State University
    Hilliard, Ohio, United States, 43026
    Status
    Not applicable
    Location
    Peggy and Charles Stephenson Oklahoma Cancer Center
    Oklahoma City, Oklahoma, United States, 73104
    Status
    Not applicable
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