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History of Changes for Study: NCT02606305
Study of IMGN853 in Comb. With Bevacizumab, Carboplatin or PLD in Adults With FRa + Adv. EOC, Primary Peritoneal, Fallopian Tube, or Endometrial Cancer
Latest version (submitted January 19, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 13, 2015 None (earliest Version on record)
2 December 10, 2015 Recruitment Status, Study Status and Contacts/Locations
3 June 14, 2016 Contacts/Locations and Study Status
4 August 24, 2016 Arms and Interventions, Outcome Measures, Study Status, Study Identification, Contacts/Locations, Eligibility, Study Design and Study Description
5 September 27, 2016 Study Status and Study Identification
6 April 7, 2017 Study Status and Study Identification
7 May 23, 2017 Contacts/Locations and Study Status
8 June 13, 2017 Study Status and Study Identification
9 February 16, 2018 Study Status, Arms and Interventions, Conditions, Study Identification, Eligibility and Study Description
10 December 5, 2018 Study Status, Contacts/Locations, Study Design, Study Identification, Eligibility and Study Description
11 May 28, 2019 Contacts/Locations, Outcome Measures, Study Status, Eligibility, Arms and Interventions and Study Description
12 August 28, 2019 Contacts/Locations and Study Status
13 September 10, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
14 March 1, 2021 Arms and Interventions, Outcome Measures, Study Status, Study Description, Oversight, Study Identification, Eligibility and Study Design
15 October 8, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
16 December 13, 2021 Study Status
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Results Submission Events
17 January 19, 2024 Outcome Measures, Study Status, More Information, Document Section, Adverse Events, Baseline Characteristics, Participant Flow, Contacts/Locations, Eligibility, Conditions and Study Description
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Study NCT02606305
Submitted Date:  November 13, 2015 (v1)
Open or close this module Study Identification
Unique Protocol ID: IMGN0402
Brief Title: Study of IMGN853 in Comb. With Bevacizumab, Carboplatin or PLD in Adults With FRa + Adv. EOC, Primary Peritoneal, Fallopian Tube, or Endometrial Cancer
Official Title: A Phase 1b Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Mirvetuximab Soravtansine (IMGN853) in Combination With Bevacizumab, Carboplatin or Pegylated Liposomal Doxorubicin in Adults With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer, or Endometrial Cancer
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2015
Overall Status: Not yet recruiting
Study Start: November 2015
Primary Completion: April 2018 [Anticipated]
Study Completion: October 2018 [Anticipated]
First Submitted: November 6, 2015
First Submitted that
Met QC Criteria:		 November 13, 2015
First Posted: November 17, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:		 November 13, 2015
Last Update Posted: November 17, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: ImmunoGen, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: 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 three regimens: IMGN853 administered with bevacizumab, IMGN853 administered with carboplatin, or IMGN853 administered with pegylated liposomal doxorubicin.
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.
Open or close this module Conditions
Conditions: Epithelial Ovarian Cancer
Primary Peritoneal Cancer
Fallopian Tube Cancer
Endometrial Cancer
Keywords: Epithelial ovarian cancer
Fallopian tube cancer
Primary peritoneal cancer
Endometrial cancer
IMGN853
ADC
Antibody drug conjugate
ImmunoGen
Antibody
Phase 1
Folate receptor alpha
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 145 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Regimen A
IMGN853 and bevacizumab
 Drug: IMGN853Drug: Bevacizumab
Experimental: Regimen B
Dose Escalation with IMGN853 and carboplatin
 Drug: IMGN853Drug: Carboplatin
Experimental: Regimen C
Dose Escalation with IMGN853 and doxorubicin
 Drug: IMGN853Drug: Doxorubicin
Other Names:
  • Pegylated Liposomal Doxorubicin
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), incidence of adverse events, clinically significant changes in laboratory/clinical tests and dose-limiting toxicities (DLTs) as a measure of safety and tolerability.
[ Time Frame: Up to 2.5 years ]
Secondary Outcome Measures:
1. Objective response rate (ORR); the proportion of patient achieving a complete response, partial response or stable disease (CR, PR or SD) according to RECIST1.1 and CA125 evaluations
[ Time Frame: Up to 2.5 years ]
2. 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 ]
3. 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 ]
4. PK parameters: maximum plasma concentration (Cmax) of IMGN853, bevacizumab, carboplatin and PLD
[ Time Frame: Up to 2.5 years ]
5. PK parameters: area under the time-concentration curve (AUC) of IMGN853, bevacizumab, carboplatin and PLD
[ Time Frame: Up to 2.5 years ]
6. PK parameters: terminal half-life (t½) of IMGN853, bevacizumab, carboplatin and PLD
[ Time Frame: Up to 2.5 years ]
7. PK parameters: clearance (Cl) of IMGN853, bevacizumab, carboplatin and PLD
[ Time Frame: Up to 2.5 years ]
8. PK parameters: volume of distribution at steady state (Vss) of IMGN853, bevacizumab, carboplatin and PLD
[ Time Frame: Up to 2.5 years ]
9. PK parameters: maximum time (Tmax) of IMGN853, bevacizumab, carboplatin and PLD
[ Time Frame: Up to 2.5 years ]
10. Immunogenicity: Presence of Anti-Drug Antibody (ADA)
[ Time Frame: Up to 2.5 years ]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Female
Gender Based:
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

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
  • Women who are pregnant or breast feeding
Open or close this module Contacts/Locations
Central Contact Person: ImmunoGen Clinical Operations
Telephone: 781-895-0600
Email: IMGN0402@immunogen.com
Study Officials: Rodrigo Ruiz-Soto, MD
Study Director
ImmunoGen, Inc.
Locations: United States, Oklahoma
Oklahoma City, Oklahoma, United States
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services