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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

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ClinicalTrials.gov Identifier: NCT02606305
Recruitment Status : Recruiting
First Posted : November 17, 2015
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
ImmunoGen, Inc.

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer Drug: IMGN853 Drug: Bevacizumab Drug: Carboplatin Drug: Pegylated Liposomal Doxorubicin Drug: Pembrolizumab Drug: Bevacizumab+Carboplatin Phase 1 Phase 2

Detailed Description:
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 355 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 2015
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : July 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Regimen A
Dose escalation and dose expansion with IMGN853 and bevacizumab
 Drug: IMGN853
Drug: Bevacizumab
Experimental: Regimen B
Dose Escalation with IMGN853 and carboplatin
 Drug: IMGN853
Drug: Carboplatin
Experimental: Regimen C
Dose Escalation with IMGN853 and pegylated liposomal doxorubicin
 Drug: IMGN853
Drug: Pegylated Liposomal Doxorubicin
Experimental: Regimen D
Dose escalation and dose expansion with IMGN853 and pembrolizumab
 Drug: IMGN853
Drug: Pembrolizumab
Experimental: Regimen E
Dose escalation and dose expansion with IMGN853 and bevacizumab+carboplatin
 Drug: IMGN853
Drug: Bevacizumab+Carboplatin


Outcome Measures
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Primary Outcome Measures :
  1. Number of TEAEs, SAEs, incidence of adverse events, clinically significant changes in laboratory/clinical tests and dose-limiting toxicities (DLTs) as a measure of safety and tolerability [dose escalation] [ Time Frame: Up to 2.5 years ]
  2. Objective response rate (ORR); the proportion of patients achieving a complete response, partial response or stable disease (CR, PR or SD) according to RECIST1.1 and CA125 evaluations [dose expansion only] [ Time Frame: Up to 2.5 years ]

Secondary Outcome Measures :
  1. Duration of response (DOR); the time from initial response until progressive disease, will be estimated for all patients who achieve a confirmed objective response (PR or CR) [ Time Frame: Up to 2.5 years ]
  2. Progression-free survival (PFS); the time from date of first dose until the date of objective disease progression or death by any cause as defined by RECIST 1.1. [ Time Frame: Up to 2.5 years ]
  3. PK parameters: maximum plasma concentration (Cmax) of IMGN853, bevacizumab, carboplatin and PLD [ Time Frame: Up to 2.5 years ]
  4. PK parameters: area under the time-concentration curve (AUC) of IMGN853, bevacizumab, carboplatin and PLD [ Time Frame: Up to 2.5 years ]
  5. PK parameters: terminal half-life (t½) of IMGN853, bevacizumab, carboplatin and PLD [ Time Frame: Up to 2.5 years ]
  6. PK parameters: clearance (Cl) of IMGN853, bevacizumab, carboplatin and PLD [ Time Frame: Up to 2.5 years ]
  7. PK parameters: volume of distribution at steady state (Vss) of IMGN853, bevacizumab, carboplatin and PLD [ Time Frame: Up to 2.5 years ]
  8. PK parameters: maximum time (Tmax) of IMGN853, bevacizumab, carboplatin and PLD [ Time Frame: Up to 2.5 years ]
  9. Immunogenicity: Presence of Anti-Drug Antibody (ADA) [ Time Frame: Up to 2.5 years ]
  10. Number of patients with CA125 clinical response. [ Time Frame: Up to 2.5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
  • 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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02606305


Contacts
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Contact: ImmunoGen Clinical Operations 781-895-0600 IMGN0402@immunogen.com

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, Ohio
The Ohio State University Recruiting
Hilliard, Ohio, United States, 43026
United States, Oklahoma
Peggy and Charles Stephenson Oklahoma Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Belgium
Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg - Leuvens Kankerinstituut Recruiting
Leuven, Belgium, 3000
Canada
Hamilton Health Sciences Center Recruiting
Hamilton, Canada
Centre Hospitalier de l'universite de Montreal (CHUM) Recruiting
Montreal, Canada
McGill University Recruiting
Montreal, Canada
Spain
MD Anderson Suspended
Madrid, Spain, 28033
Sponsors and Collaborators
ImmunoGen, Inc.
Investigators
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Study Director: Karim Malek, MD ImmunoGen, Inc.
More Information
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Responsible Party: ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT02606305     History of Changes
Other Study ID Numbers: IMGN853-0402
KEYNOTE PN409 ( Other Identifier: Merck )
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

Keywords provided by ImmunoGen, Inc.:
Epithelial ovarian cancer
Fallopian tube cancer
Primary peritoneal cancer
IMGN853
ADC
 Antibody drug conjugate
ImmunoGen
Antibody
Phase 1
Folate receptor alpha

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Bevacizumab
Pembrolizumab
Carboplatin
Doxorubicin
Liposomal doxorubicin
Maytansine
Antibodies
Immunoconjugates