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

Study Description

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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 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

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 :	200 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
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, 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 :	December 2019
Estimated Study Completion Date :	June 2020

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, 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
• 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

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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
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
McGill University	Recruiting
Montreal, Canada
Spain
MD Anderson	Recruiting
Madrid, Spain, 28033

Sponsors and Collaborators

ImmunoGen, Inc.

Investigators

Study Director:	Karim Malek, MD	ImmunoGen, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	ImmunoGen, Inc.
ClinicalTrials.gov Identifier:	NCT02606305 History of Changes
Other Study ID Numbers:	IMGN0402; KEYNOTE PN409 ( Other Identifier: Merck )
First Posted:	November 17, 2015
Last Update Posted:	February 22, 2018
Last Verified:	February 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:

Ovarian Neoplasms; Fallopian Tube 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	Abdominal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Neoplasms by Histologic Type; Bevacizumab; Liposomal doxorubicin; Pembrolizumab; Carboplatin; Doxorubicin; Maytansine; Antibodies; Immunoconjugates; Angiogenesis Inhibitors; Angiogenesis Modulating Agents