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 - Full Text View

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:

Genetics Home Reference related topics: ovarian cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Carboplatin Bevacizumab Pembrolizumab

Genetic and Rare Diseases Information Center resources: Ovarian Cancer Ovarian Epithelial Cancer Fallopian Tube Cancer

U.S. FDA Resources

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
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


Responsible Party:	ImmunoGen, Inc.
ClinicalTrials.gov Identifier:	NCT02606305 History of Changes
Other Study ID Numbers:	IMGN0402 KEYNOTE PN409 ( Other Identifier: Merck )
Study First Received:	November 6, 2015
Last Updated:	June 13, 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 Bevacizumab Liposomal doxorubicin Pembrolizumab Carboplatin Doxorubicin Antibodies Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on July 25, 2017