PH3 Study of Mirvetuximab Soravtansine vs Investigator's Choice of Chemotherapy in Women With FRa+ Adv. EOC, Primary Peritoneal or Fallopian Tube Cancer



Status:Active, not recruiting
Conditions:Ovarian Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:November 2016
End Date:June 2020

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FORWARD I: A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Women With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer

This is a Phase 3, open label, randomized study designed to compare the safety and efficacy
of IMGN853 to that of selected single-agent chemotherapy (Investigator's choice) in women
with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal cancer and/or
fallopian tube cancer.

Patients will be randomized to either IMGN853 or Investigator's Choice chemotherapy.

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

- Patients must have platinum-resistant ovarian cancer, defined as progression within 6
months from completion of a minimum of four cycles of platinum-containing therapy.

- Patients must have received at least one but no more than three prior systemic
treatment regimens and for whom single-agent chemotherapy is appropriate as the next
line of treatment

- Patients must have at least one lesion that meets the definition of measurable disease
by RECIST 1.1

Exclusion Criteria:

- Diagnosis of clear cell or low grade ovarian cancer

- Patients with primary platinum-refractory disease

- Serious concurrent illness or clinically relevant active infection as defined in the
protocol

- Prior treatment with IMGN853

- Women who are pregnant or breast feeding
We found this trial at
54
sites
Charlotte, North Carolina 28204
Principal Investigator: Erine Crane, MD
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Michael Birrer, MD, PhD
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Cesar Castro, MD
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Boston, MA
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
Principal Investigator: Eric Eisenhauer, MD
University of Cincinnati Medical Center Opening in 1823 as the country
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Peter Rose, MD
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Vallejo, California 94589
Principal Investigator: Ramey Littell, MD
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Albuquerque, New Mexico 87131
Principal Investigator: Carolyn Muller, MD
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Augusta, GA
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Austin, Texas 78731
Principal Investigator: Michael Teneriello, MD
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Austin, TX
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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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Brussels,
Principal Investigator: Jean-Francois Baurain, MD
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1 Cooper Plaza
Camden, New Jersey 08103
Principal Investigator: David Warshal, MD
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Charleston, South Carolina 29425
Principal Investigator: Whitney Graybill, MD
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Lydia Usha, MD
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Columbus, Ohio 43210
Principal Investigator: David M O'Malley, MD
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Covington, Louisiana 70433
Principal Investigator: Patricia Braly, MD
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: David S Miller, MD
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Detroit, Michigan 48201
Principal Investigator: Shelly Seward, MD
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Thomas Buekers, MD
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Fort Worth, Texas 76104
Principal Investigator: Noelle G Cloven, MD
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Hinsdale, Illinois
Principal Investigator: Sudarshan Sharma, MD
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Indianapolis, Indiana 46256
Principal Investigator: Michael Method, MD
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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Kennewick, Washington 99336
Principal Investigator: Ying Zhuo, MD
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Kennewick, WA
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Leslie DeMars, MD
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Louisville, Kentucky 40207
Principal Investigator: Mary Gordinier, MD
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Mayfield, Ohio 44124
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9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
(414) 805-3666
Principal Investigator: William Bradley, MD
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Alessandro Santin, MD
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New Orleans, Louisiana 70121
Principal Investigator: Katrina Wade, MD
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New York, New York 10016
Principal Investigator: Bhavana Pothuri, MD
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500 Westchester Avenue
New York, New York 10065
Principal Investigator: Jason Konner, MD
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Monica Prasad Hayes, MD
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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34 Maple St
Norwalk, Connecticut 06856
Principal Investigator: George Zahrah, MD
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Kathleen Moore, MD
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Janos Tanyi, MD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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300 Halket St.
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Principal Investigator: Alexander Olawaiye, MD
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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100 Dudley Street
Providence, Rhode Island 02905
Principal Investigator: Paul DiSilvestro, MD
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75 Pringle Way
Reno, Nevada 89502
Principal Investigator: Peter Lim, MD
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San Diego, California 92103
Principal Investigator: Michael McHale, MD
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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Sarasota, Florida
Principal Investigator: James Fiorica, MD
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1202 Louisiana Avenue
Shreveport, Louisiana 71101
Principal Investigator: Destin Black, MD
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Silver Spring, Maryland 20910
Principal Investigator: James Barter, MD
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2055 South Fremont Avenue
Springfield, Missouri 65804
Principal Investigator: Jay Carlson, MD
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Summit, New Jersey 07901
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7695 South Research Drive
Tempe, Arizona 85284
Principal Investigator: Snehalkumar Bhoola, MD
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The Woodlands, Texas 77380
Principal Investigator: Christine M Lee, MD
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Tucson, Arizona 85704
Principal Investigator: Joseph Buscema, MD
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Tulsa, Oklahoma 74146
Principal Investigator: Michael A Gold, MD
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Tyler, Texas 75702
Principal Investigator: Donald Richards, MD
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Tyler, TX
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Worcester, Massachusetts 01655
Principal Investigator: Susan Zweizig, MD
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