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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02631876
Recruitment Status : Active, not recruiting
First Posted : December 16, 2015
Last Update Posted : May 2, 2018
Gynecologic Oncology Group
Information provided by (Responsible Party):
ImmunoGen, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Cancer Ovarian Cancer Drug: IMGN853 Drug: Paclitaxel Drug: Doxorubicin Drug: Topotecan Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 333 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : February 2019

Arm Intervention/treatment
Experimental: Arm 1
IMGN853 administered at 6 mg/kg AIBW once every three weeks (Q3W)
Drug: IMGN853
Other Name: mirvetuximab soravtansine

Experimental: Arm 2
Paclitaxel, Pegylated Liposomal Doxorubicin, or Topotecan
Drug: Paclitaxel
Drug: Doxorubicin
Other Name: Pegylated Liposomal Doxorubicin

Drug: Topotecan

Primary Outcome Measures :
  1. Progression free survival in all patients randomized to the study and in patients with high folate receptor alpha expression [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) per RECIST1.1 [ Time Frame: Up to 2 years ]
  2. Overall survival (OS) as measured from the date of randomization until the date of death. [ Time Frame: Up to 2 years ]
  3. Quality of life [ Time Frame: Up to 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02631876

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Sponsors and Collaborators
ImmunoGen, Inc.
Gynecologic Oncology Group
Study Director: Karim Malek, MD ImmunoGen, Inc.

Responsible Party: ImmunoGen, Inc. Identifier: NCT02631876     History of Changes
Other Study ID Numbers: IMGN853-0403
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: March 2018

Keywords provided by ImmunoGen, Inc.:
Epithelial ovarian cancer
Fallopian tube cancer
Primary peritoneal cancer
Antibody drug conjugate
Folate receptor alpha
mirvetuximab soravtansine
Phase 3

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Fallopian Tube Diseases
Liposomal doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs