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
Epithelial Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
About this trial
This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring Epithelial ovarian cancer, Fallopian tube cancer, Primary peritoneal cancer, IMGN853, ADC, Antibody drug conjugate, ImmunoGen, Antibody, Phase 1, Folate receptor alpha
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with advanced epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- FRα positive tumor expression as defined in the protocol
- Willing to provide an archival tumor tissue block or slides or undergo tumor biopsy. New tumor biopsy (Cycle 2 Day 8) is required for Regimen D.
- Measurable disease
Exclusion Criteria:
- Primary platinum-refractory disease
- Diagnosis of clear cell, low grade ovarian cancer or mixed tumors
- Serious concurrent illness or clinically relevant active infection, including but not limited to known diagnosis of human immunodeficiency virus (HIV) and hepatitis B or C, as defined in the protocol
- Active autoimmune disease requiring systemic therapy in past 2 years (for Regimen D only)
- Women who are pregnant or breastfeeding
- Male participants
Sites / Locations
- University of Alabama
- University of California at Los Angeles
- Massachusetts General Hospital
- Dana-Farber Cancer Institute
- City of Hope
- The Ohio State University
- Peggy and Charles Stephenson Oklahoma Cancer Center
- Fox Chase Cancer Center
- Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg - Leuvens Kankerinstituut
- Juravinski Cancer Center
- Tom Baker Cancer Center
- Centre Hospitalier de l'universite de Montreal (CHUM)
- McGill University Health Center
- Princess Margaret Cancer Center
- Hospital Vall D'Hebron
- MD Anderson
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Regimen A (Mirvetuximab soravtansine + Bevacizumab)
Regimen B (Mirvetuximab soravtansine + Carboplatin)
Regimen C (Mirvetuximab soravtansine + Pegylated liposomal doxorubicin)
Regimen D (Mirvetuximab soravtansine + Pembrolizumab)
Regimen E (Mirvetuximab soravtansine + Bevacizumab + Carboplatin)
Mirvetuximab soravtansine + Bevacizumab administered on Day 1 of each 21-day cycle in Dose Escalation and Dose Expansion phase.
Mirvetuximab soravtansine + Carboplatin administered on Day 1 of each 21-day cycle in Dose Escalation phase.
Mirvetuximab soravtansine + Pegylated liposomal doxorubicin administered on Day 1 of each 28-day cycle in Dose Escalation Phase.
Mirvetuximab soravtansine + Pembrolizumab administered on Day 1 of each 21-day cycle in Dose Escalation and Dose Expansion phase.
Mirvetuximab soravtansine + Bevacizumab + Carboplatin administered on Day 1 of each 21-day cycle in Dose Expansion phase.