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
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ClinicalTrials.gov Identifier: NCT02606305 |
Recruitment Status :
Active, not recruiting
First Posted : November 17, 2015
Last Update Posted : September 12, 2019
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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 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 264 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1b/2 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 : | January 2021 |
Estimated Study Completion Date : | July 2021 |

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 expansion with IMGN853 and bevacizumab+carboplatin
|
Drug: IMGN853 Drug: Bevacizumab+Carboplatin |
- Incidence of TEAEs, SAEs, 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 (CR or PR) according to RECIST1.1 and CA125 evaluations [dose expansion only] [ Time Frame: Up to 2.5 years ]
- Duration of response (DOR); the time from first objective response until progressive disease, will be calculated 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
- Measurable disease
Exclusion Criteria:
- Primary platinum-refractory EOC
- Diagnosis of clear cell, low grade ovarian cancer or mixed tumors
- 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 breastfeeding
- Male patients

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02606305
United States, Alabama | |
University of Alabama | |
Birmingham, Alabama, United States | |
United States, California | |
University of California at Los Angeles | |
Los Angeles, California, United States | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02215 | |
United States, Nevada | |
City of Hope | |
Reno, Nevada, United States | |
United States, Ohio | |
The Ohio State University | |
Hilliard, Ohio, United States, 43026 | |
United States, Oklahoma | |
Peggy and Charles Stephenson Oklahoma Cancer Center | |
Oklahoma City, Oklahoma, United States, 73104 | |
United States, Pennsylvania | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 | |
Belgium | |
Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg - Leuvens Kankerinstituut | |
Leuven, Belgium, 3000 | |
Canada | |
Juravinski Cancer Center | |
Calgary, Canada | |
Tom Baker Cancer Center | |
Hamilton, Canada | |
Centre Hospitalier de l'universite de Montreal (CHUM) | |
Montreal, Canada | |
McGill University Health Center | |
Montreal, Canada | |
Princess Margaret Cancer Center | |
Toronto, Canada | |
Spain | |
Hospital Vall D'Hebron | |
Barcelona, Spain | |
MD Anderson | |
Madrid, Spain, 28033 |
Study Director: | Patrick Zweidler-McKay, MD, PhD | ImmunoGen, Inc. |
Responsible Party: | ImmunoGen, Inc. |
ClinicalTrials.gov Identifier: | NCT02606305 |
Other Study ID Numbers: |
IMGN853-0402 KEYNOTE PN409 ( Other Identifier: Merck ) |
First Posted: | November 17, 2015 Key Record Dates |
Last Update Posted: | September 12, 2019 |
Last Verified: | September 2019 |
Epithelial ovarian cancer Fallopian tube cancer Primary peritoneal cancer IMGN853 ADC |
Antibody drug conjugate ImmunoGen Antibody Phase 1 Folate receptor alpha |
Ovarian Neoplasms Carcinoma, Ovarian Epithelial Fallopian Tube Neoplasms Peritoneal Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Fallopian Tube Diseases Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Bevacizumab Pembrolizumab Carboplatin Doxorubicin Liposomal doxorubicin Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents |