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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 (FORWARD I)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by ImmunoGen, Inc.
Sponsor:
Collaborator:
Gynecologic Oncology Group
Information provided by (Responsible Party):
ImmunoGen, Inc.
ClinicalTrials.gov Identifier:
NCT02631876
First received: December 10, 2015
Last updated: June 7, 2017
Last verified: June 2017
  Purpose
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 Intervention Phase
Epithelial Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Cancer Ovarian Cancer Drug: IMGN853 Drug: Paclitaxel Drug: Doxorubicin Drug: Topotecan Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by ImmunoGen, Inc.:

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

Estimated Enrollment: 333
Study Start Date: November 2016
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02631876

Contacts
Contact: ImmunoGen Clinical Operations 781-895-0600 IMGN0403@immunogen.com

  Show 47 Study Locations
Sponsors and Collaborators
ImmunoGen, Inc.
Gynecologic Oncology Group
Investigators
Study Director: Karim Malek, MD ImmunoGen, Inc.
  More Information

Responsible Party: ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT02631876     History of Changes
Other Study ID Numbers: IMGN0403
Study First Received: December 10, 2015
Last Updated: June 7, 2017

Keywords provided by ImmunoGen, Inc.:
Epithelial ovarian cancer
Fallopian tube cancer
Primary peritoneal cancer
IMGN853
ADC
Antibody drug conjugate
ImmunoGen
Antibody
Folate receptor alpha
mirvetuximab soravtansine
Phase 3
platinum-resistant

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Neoplasms by Histologic Type
Paclitaxel
Liposomal doxorubicin
Doxorubicin
Topotecan
Antibodies
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 23, 2017