Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Study of Mirvetuximab Soravtansine in Comb. With Bevacizumab, Carboplatin, PLD or Pembrolizumab in Adults With FRa + Adv. EOC, Primary Peritoneal, Fallopian Tube, or Endometrial Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by ImmunoGen, Inc.
Sponsor:
Information provided by (Responsible Party):
ImmunoGen, Inc.
ClinicalTrials.gov Identifier:
NCT02606305
First received: November 6, 2015
Last updated: April 7, 2017
Last verified: September 2016
  Purpose
This is a phase 1b 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 or IMGN853 administered with pembrolizumab.

Condition Intervention Phase
Epithelial Ovarian Cancer
Primary Peritoneal Cancer
Fallopian Tube Cancer
Endometrial Cancer
Drug: IMGN853
Drug: Bevacizumab
Drug: Carboplatin
Drug: Pegylated Liposomal Doxorubicin
Drug: Pembrolizumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 1b Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Mirvetuximab Soravtansine (IMGN853) in Combination With Bevacizumab, Carboplatin, Pegylated Liposomal Doxorubicin or Pembrolizumab in Adults With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer, or Endometrial Cancer

Resource links provided by NLM:


Further study details as provided by ImmunoGen, Inc.:

Primary Outcome Measures:
  • 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 ]
  • 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:
  • 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 ]
  • 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 ]
  • PK parameters: maximum plasma concentration (Cmax) of IMGN853, bevacizumab, carboplatin and PLD [ Time Frame: Up to 2.5 years ]
  • PK parameters: area under the time-concentration curve (AUC) of IMGN853, bevacizumab, carboplatin and PLD [ Time Frame: Up to 2.5 years ]
  • PK parameters: terminal half-life (t½) of IMGN853, bevacizumab, carboplatin and PLD [ Time Frame: Up to 2.5 years ]
  • PK parameters: clearance (Cl) of IMGN853, bevacizumab, carboplatin and PLD [ Time Frame: Up to 2.5 years ]
  • PK parameters: volume of distribution at steady state (Vss) of IMGN853, bevacizumab, carboplatin and PLD [ Time Frame: Up to 2.5 years ]
  • PK parameters: maximum time (Tmax) of IMGN853, bevacizumab, carboplatin and PLD [ Time Frame: Up to 2.5 years ]
  • Immunogenicity: Presence of Anti-Drug Antibody (ADA) [ Time Frame: Up to 2.5 years ]
  • Number of patients with CA125 clinical response. [ Time Frame: Up to 2.5 years ]

Estimated Enrollment: 200
Study Start Date: December 2015
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Doxorubicin
Experimental: Regimen D
Dose escalation and dose expansion with IMGN853 and pembrolizumab
Drug: IMGN853 Drug: Pembrolizumab

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.
  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, fallopian tube cancer, or endometrial cancer
  • Folate receptor alpha positive tumor expression as defined in the protocol
  • Willing to undergo tumor biopsy

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 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: NCT02606305

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

Locations
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
Hillard, 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
McGill University Recruiting
Montreal, Canada
Spain
MD Anderson Recruiting
Madrid, Spain, 28033
Sponsors and Collaborators
ImmunoGen, Inc.
Investigators
Study Director: Rodrigo Ruiz-Soto, MD ImmunoGen, Inc.
  More Information

Responsible Party: ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT02606305     History of Changes
Other Study ID Numbers: IMGN0402
Keynote-409 ( Other Identifier: Merck )
Study First Received: November 6, 2015
Last Updated: April 7, 2017

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

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Endometrial Neoplasms
Peritoneal 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
Uterine Neoplasms
Uterine Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Neoplasms by Histologic Type
Liposomal doxorubicin
Pembrolizumab
Carboplatin
Bevacizumab
Doxorubicin
Antibodies
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 24, 2017