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
Kennewick, Washington 99336
Principal Investigator: Ying Zhuo, MD
1236
mi
from
Kennewick, WA
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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...
676
mi
from
Birmingham, AL
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Cesar Castro, MD
1443
mi
from
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
724
mi
from
Cincinnati, OH
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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...
898
mi
from
Cleveland, OH
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Vallejo, California 94589
Principal Investigator: Ramey Littell, MD
1327
mi
from
Vallejo, CA
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Albuquerque, New Mexico 87131
Principal Investigator: Carolyn Muller, MD
522
mi
from
Albuquerque, NM
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?
mi
from
Augusta, GA
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Austin, Texas 78731
Principal Investigator: Michael Teneriello, MD
511
mi
from
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...
1444
mi
from
Boston, MA
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Brussels,
Principal Investigator: Jean-Francois Baurain, MD
4719
mi
from
Brussels,
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1 Cooper Plaza
Camden, New Jersey 08103
Principal Investigator: David Warshal, MD
1227
mi
from
Camden, NJ
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Charleston, South Carolina 29425
Principal Investigator: Whitney Graybill, MD
1063
mi
from
Charleston, SC
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Charlotte, North Carolina 28204
Principal Investigator: Erine Crane, MD
957
mi
from
Charlotte, NC
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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...
608
mi
from
Chicago, IL
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889
mi
from
Cleveland, OH
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Columbus, Ohio 43210
Principal Investigator: David M O'Malley, MD
810
mi
from
Columbus, OH
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Covington, Louisiana 70433
Principal Investigator: Patricia Braly, MD
668
mi
from
Covington, LA
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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...
349
mi
from
Dallas, TX
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Detroit, Michigan 48201
Principal Investigator: Shelly Seward, MD
841
mi
from
Detroit, MI
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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...
841
mi
from
Detroit, MI
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Fort Worth, Texas 76104
Principal Investigator: Noelle G Cloven, MD
346
mi
from
Fort Worth, TX
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Hinsdale, Illinois
Principal Investigator: Sudarshan Sharma, MD
594
mi
from
Hinsdale, IL
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Indianapolis, Indiana 46256
Principal Investigator: Michael Method, MD
651
mi
from
Indianapolis, IN
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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...
643
mi
from
Indianapolis, IN
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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...
1393
mi
from
Lebanon, NH
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?
mi
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Los Angeles, CA
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Louisville, Kentucky 40207
Principal Investigator: Mary Gordinier, MD
663
mi
from
Louisville, KY
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Mayfield, Ohio 44124
?
mi
from
Mayfield, OH
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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...
630
mi
from
Milwaukee, WI
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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...
1344
mi
from
New Haven, CT
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New Orleans, Louisiana 70121
Principal Investigator: Katrina Wade, MD
694
mi
from
New Orleans, LA
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New York, New York 10016
Principal Investigator: Bhavana Pothuri, MD
1288
mi
from
New York, NY
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500 Westchester Avenue
New York, New York 10065
Principal Investigator: Jason Konner, MD
1301
mi
from
New York, NY
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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...
?
mi
from
New York, NY
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34 Maple St
Norwalk, Connecticut 06856
Principal Investigator: George Zahrah, MD
1318
mi
from
Norwalk, CT
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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...
153
mi
from
Oklahoma City, OK
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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...
1223
mi
from
Philadelphia, PA
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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...
974
mi
from
Pittsburgh, PA
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100 Dudley Street
Providence, Rhode Island 02905
Principal Investigator: Paul DiSilvestro, MD
1424
mi
from
Providence, RI
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75 Pringle Way
Reno, Nevada 89502
Principal Investigator: Peter Lim, MD
1189
mi
from
Reno, NV
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San Diego, California 92103
Principal Investigator: Michael McHale, MD
1142
mi
from
San Diego, CA
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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,...
1340
mi
from
San Francisco, CA
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Sarasota, Florida
Principal Investigator: James Fiorica, MD
1142
mi
from
Sarasota, FL
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1202 Louisiana Avenue
Shreveport, Louisiana 71101
Principal Investigator: Destin Black, MD
429
mi
from
Shreveport, LA
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Silver Spring, Maryland 20910
Principal Investigator: James Barter, MD
1126
mi
from
Silver Spring, MD
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2055 South Fremont Avenue
Springfield, Missouri 65804
Principal Investigator: Jay Carlson, MD
252
mi
from
Springfield, MO
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Summit, New Jersey 07901
1268
mi
from
Summit, NJ
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7695 South Research Drive
Tempe, Arizona 85284
Principal Investigator: Snehalkumar Bhoola, MD
846
mi
from
Tempe, AZ
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The Woodlands, Texas 77380
Principal Investigator: Christine M Lee, MD
543
mi
from
The Woodlands, TX
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Tucson, Arizona 85704
Principal Investigator: Joseph Buscema, MD
832
mi
from
Tucson, AZ
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Tulsa, Oklahoma 74146
Principal Investigator: Michael A Gold, MD
158
mi
from
Tulsa, OK
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Tyler, Texas 75702
Principal Investigator: Donald Richards, MD
398
mi
from
Tyler, TX
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Worcester, Massachusetts 01655
Principal Investigator: Susan Zweizig, MD
1408
mi
from
Worcester, MA
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