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History of Changes for Study: NCT02631876
PH2 Study of IMGN853 vs Investigator's Choice of Chemo in Adults With FRa+ Adv. EOC, Primary Peritoneal or Primary Fallopian Tube Cancer
Latest version (submitted September 24, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 11, 2015 None (earliest Version on record)
2 December 21, 2015 Sponsor/Collaborators and Study Status
3 January 28, 2016 Recruitment Status, Study Status and Contacts/Locations
4 February 1, 2016 Study Status and Oversight
5 May 31, 2016 Recruitment Status, Study Status and Contacts/Locations
6 November 4, 2016 Recruitment Status, Contacts/Locations, Arms and Interventions, Study Status, Outcome Measures, Study Identification, Study Design, Conditions, Study Description and Eligibility
7 November 17, 2016 Contacts/Locations and Study Status
8 December 7, 2016 Contacts/Locations and Study Status
9 January 12, 2017 Contacts/Locations and Study Status
10 January 13, 2017 Contacts/Locations and Study Status
11 January 19, 2017 Contacts/Locations and Study Status
12 January 20, 2017 Contacts/Locations and Study Status
13 January 31, 2017 Contacts/Locations and Study Status
14 February 6, 2017 Contacts/Locations and Study Status
15 February 8, 2017 Study Status and Contacts/Locations
16 February 14, 2017 Study Status and Contacts/Locations
17 March 2, 2017 Contacts/Locations and Study Status
18 March 3, 2017 Study Status and Contacts/Locations
19 March 23, 2017 Contacts/Locations and Study Status
20 March 28, 2017 Contacts/Locations and Study Status
21 March 30, 2017 Contacts/Locations and Study Status
22 April 3, 2017 Study Status and Contacts/Locations
23 April 7, 2017 Study Status and Study Identification
24 April 11, 2017 Contacts/Locations and Study Status
25 April 19, 2017 Contacts/Locations and Study Status
26 April 21, 2017 Contacts/Locations and Study Status
27 April 25, 2017 Contacts/Locations and Study Status
28 April 27, 2017 Contacts/Locations and Study Status
29 May 2, 2017 Contacts/Locations and Study Status
30 May 31, 2017 Study Status and Contacts/Locations
31 June 2, 2017 Study Status and Contacts/Locations
32 June 7, 2017 Contacts/Locations and Study Status
33 June 23, 2017 Contacts/Locations and Study Status
34 July 10, 2017 Study Status and Contacts/Locations
35 July 11, 2017 Contacts/Locations and Study Status
36 July 13, 2017 Contacts/Locations and Study Status
37 July 19, 2017 Contacts/Locations and Study Status
38 July 25, 2017 Contacts/Locations and Study Status
39 July 31, 2017 Contacts/Locations and Study Status
40 August 4, 2017 Study Status and Contacts/Locations
41 August 11, 2017 Contacts/Locations and Study Status
42 August 28, 2017 Contacts/Locations and Study Status
43 September 6, 2017 Study Status and Contacts/Locations
44 October 16, 2017 Contacts/Locations and Study Status
45 November 3, 2017 Contacts/Locations and Study Status
46 November 14, 2017 Contacts/Locations and Study Status
47 December 6, 2017 Contacts/Locations and Study Status
48 December 21, 2017 Study Identification and Study Status
49 January 17, 2018 Contacts/Locations and Study Status
50 January 23, 2018 Contacts/Locations and Study Status
51 February 6, 2018 Contacts/Locations and Study Status
52 February 26, 2018 Contacts/Locations and Study Status
53 March 20, 2018 Study Status and Contacts/Locations
54 April 30, 2018 Recruitment Status, Contacts/Locations, Study Status and Study Design
55 February 11, 2019 Study Status and Contacts/Locations
56 May 16, 2019 Study Status, Arms and Interventions, Eligibility, Outcome Measures, Study Design and Study Identification
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Results Submission Events
57 June 6, 2020 Recruitment Status, Study Status, Outcome Measures, Arms and Interventions, Study Description, Oversight, Document Section, Results, Contacts/Locations, Eligibility, Conditions and Study Identification
58 September 24, 2020 Outcome Measures and Study Status
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Study NCT02631876
Submitted Date:  December 11, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: IMGN0403
Brief Title: PH2 Study of IMGN853 vs Investigator's Choice of Chemo in Adults With FRa+ Adv. EOC, Primary Peritoneal or Primary Fallopian Tube Cancer
Official Title: FORWARD1: A Randomized, Open Label Phase 2 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Adults With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Primary Fallopian Tube Cancer
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2015
Overall Status: Not yet recruiting
Study Start: December 2015
Primary Completion: March 2018 [Anticipated]
Study Completion: September 2018 [Anticipated]
First Submitted: December 10, 2015
First Submitted that
Met QC Criteria:
December 11, 2015
First Posted: December 16, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 11, 2015
Last Update Posted: December 16, 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: Yes
Open or close this module Study Description
Brief Summary: This is a Phase 2, open label, randomized study. Stage 1 is designed to select the dosing schedule for IMGN853. Stage 2 is designed to compare the efficacy of IMGN853 to that of selected standard of care chemotherapy (Investigator's choice) in patients with FR-alpha positive advanced EOC, primary peritoneal cancer or fallopian tube cancer.
Detailed Description: In Stage 1, patients will be randomized to one of two Schedules, IMGN853 administered Q3W or IMGN853 administered Q4W. In Stage 2, patients will be randomized to either IMGN853 at the selected schedule or Investigator's Choice chemotherapy.
Open or close this module Conditions
Conditions: Epithelial Ovarian Cancer
Primary Peritoneal Carcinoma
Primary Fallopian Tube Cancer
Keywords: Epithelial ovarian cancer
Fallopian tube cancer
Primary peritoneal cancer
IMGN853
ADC
Antibody drug conjugate
ImmunoGen
Antibody
Phase 2
Folate receptor alpha
mirvetuximab soravtansine
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 247 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Stage 1: Schedule A
IMGN853 administered at 6 mg/kg AIBW once every three weeks (Q3W)
Drug: IMGN853
Other Names:
  • mirvetuximab soravtansine
Experimental: Stage 1: Schedule B
IMGN853 administered at 6 mg/kg AIBW once every four weeks (Q4W)
Drug: IMGN853
Other Names:
  • mirvetuximab soravtansine
Experimental: Stage 2: Arm 1
IMGN853 administered at 6 mg/kg (Q3W or Q4W)
Drug: IMGN853
Other Names:
  • mirvetuximab soravtansine
Experimental: Stage 2: Arm 2
Paclitaxel, Pegylated Liposomal Doxorubicin, Gemcitabine or Topotecan
Drug: PaclitaxelDrug: Doxorubicin
Other Names:
  • Pegylated Liposomal Doxorubicin
Drug: GemcitabineDrug: Topotecan
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of treatment emergent adverse events (TEAEs) and clinically significant changes in laboratory/clinical tests as a measure of safety
[ Time Frame: Up to 2 years ]

Secondary Outcome Measures:
1. 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
[ Time Frame: Up to 2 years ]

2. PK parameters: maximum plasma concentration (Cmax) of IMGN853
[ Time Frame: Up to 2 years ]

3. PK parameters: area under the time-concentration curve (AUC) of IMGN853
[ Time Frame: Up to 2 years ]

4. PK parameters: terminal half-life (t½) of IMGN853
[ Time Frame: Up to 2 years ]

5. PK parameters: clearance (Cl) of IMGN853
[ Time Frame: Up to 2 years ]

6. PK parameters: volume of distribution at steady state (Vss) of IMGN853
[ Time Frame: Up to 2 years ]

7. PK parameters: maximum time (Tmax) of IMGN853
[ Time Frame: Up to 2 years ]

8. Immunogenicity: Presence of Anti-Drug Antibody (ADA)
[ Time Frame: Up to 2 years ]

9. Quality of life as assessed using Fact-O Questionnaire
[ Time Frame: Up to 2 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 or fallopian tube cancer
  • Folate receptor alpha positive tumor expression as defined in the protocol

Exclusion Criteria:

  • 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
  • Prior treatment with IMGN853
  • 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: IMGN0403@immunogen.com
Study Officials: Rodrigo Ruiz-Soto, MD
Study Director
ImmunoGen, Inc.
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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