Study of Mirvetuximab Soravtansine in Comb. With Bevacizumab, Carboplatin, PLD, Pembrolizumab, or Bevacizumab + Carboplatin in Adults With FRa + Adv. EOC, Primary Peritoneal or Fallopian Tube Cancer



Status:Recruiting
Conditions:Ovarian Cancer, Cervical Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Endometrial Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/9/2018
Start Date:December 2015
End Date:July 2021
Contact:ImmunoGen Clinical Operations
Email:IMGN0402@immunogen.com
Phone:781-895-0600

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A Phase 1b/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Mirvetuximab Soravtansine (IMGN853) in Combination With Bevacizumab, Carboplatin, Pegylated Liposomal Doxorubicin, Pembrolizumab, or Bevacizumab+Carboplatin in Adults With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer

This is a phase 1b/2 study to assess the safety, tolerability, and preliminary anti-tumor
activity of IMGN853 when administered with chemotherapy. Patients will be assigned to one of
four regimens: IMGN853 administered with bevacizumab, IMGN853 administered with carboplatin,
IMGN853 administered with pegylated liposomal doxorubicin, IMGN853 administered with
pembrolizumab, or IMGN853 administered with bevacizumab+carboplatin

The dose escalation part of the study will assess safety and tolerability and determine the
maximum tolerated dose (MTD) for each regimen. The dose expansion of the MTD will assess
safety, tolerability and preliminary anti-tumor activity.

Inclusion Criteria:

- Diagnosed with advanced epithelial ovarian cancer, primary peritoneal cancer, or
fallopian tube cancer

- Folate receptor alpha positive tumor expression as defined in the protocol

- Willing to undergo tumor biopsy

- Measurable disease

Exclusion Criteria:

- Primary platinum refractory

- Diagnosis of clear cell or low grade ovarian cancer

- Serious concurrent illness or clinically relevant active infection, including known
diagnosis of HIV and hepatitis B or C, as defined in the protocol

- Active autoimmune disease requiring systemic therapy in past 2 years (IMGN853 and
pembrolizumab only)

- Women who are pregnant or breastfeeding

- Male patients
We found this trial at
6
sites
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Oklahoma City, OK
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Hilliard, Ohio 43026
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Hilliard, OH
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Leuven,
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Philadelphia, Pennsylvania 19111
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Philadelphia, PA
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