Study of Mirvetuximab Soravtansine in Combination With Bevacizumab, Carboplatin, Pegylated Liposomal Doxorubicin, Pembrolizumab, or Bevacizumab + Carboplatin in Participants With Folate Receptor Alpha (FRα) Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal, or Fallopian Tube Cancer
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ClinicalTrials.gov Identifier: NCT02606305 |
Recruitment Status :
Completed
First Posted : November 17, 2015
Last Update Posted : December 17, 2021
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Condition or disease | Intervention/treatment | Phase |
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Epithelial Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer | Drug: Mirvetuximab soravtansine Drug: Bevacizumab Drug: Carboplatin Drug: Pegylated Liposomal Doxorubicin Drug: Pembrolizumab | 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 |
Actual Primary Completion Date : | March 12, 2021 |
Actual Study Completion Date : | March 12, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Regimen A (Mirvetuximab soravtansine + Bevacizumab)
Mirvetuximab soravtansine + Bevacizumab administered on Day 1 of each 21-day cycle in Dose Escalation and Dose Expansion phase.
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Drug: Mirvetuximab soravtansine
Other Name: IMGN853 Drug: Bevacizumab |
Experimental: Regimen B (Mirvetuximab soravtansine + Carboplatin)
Mirvetuximab soravtansine + Carboplatin administered on Day 1 of each 21-day cycle in Dose Escalation phase.
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Drug: Mirvetuximab soravtansine
Other Name: IMGN853 Drug: Carboplatin |
Experimental: Regimen C (Mirvetuximab soravtansine + Pegylated liposomal doxorubicin)
Mirvetuximab soravtansine + Pegylated liposomal doxorubicin administered on Day 1 of each 28-day cycle in Dose Escalation Phase.
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Drug: Mirvetuximab soravtansine
Other Name: IMGN853 Drug: Pegylated Liposomal Doxorubicin |
Experimental: Regimen D (Mirvetuximab soravtansine + Pembrolizumab)
Mirvetuximab soravtansine + Pembrolizumab administered on Day 1 of each 21-day cycle in Dose Escalation and Dose Expansion phase.
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Drug: Mirvetuximab soravtansine
Other Name: IMGN853 Drug: Pembrolizumab |
Experimental: Regimen E (Mirvetuximab soravtansine + Bevacizumab + Carboplatin)
Mirvetuximab soravtansine + Bevacizumab + Carboplatin administered on Day 1 of each 21-day cycle in Dose Expansion phase.
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Drug: Mirvetuximab soravtansine
Other Name: IMGN853 Drug: Bevacizumab Drug: Carboplatin |
- Dose Escalation (Regimens A Through D): Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to approximately 5.3 years ]
- Dose Expansion (Regimens A and D) and Triplet (Regimen E): Objective Response Rate (ORR); Percentage of Participants With Confirmed Response, as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: From first dose of study drug until first CR or PR (up to approximately 5.3 years) ]Confirmed response includes complete Response (CR) + partial response (PR).
- Dose Expansion (Regimens A and D) and Triplet (Regimen E): Number of Participants With TEAEs [ Time Frame: Baseline up to approximately 5.3 years ]
- Dose Escalation (Regimens A Through D): ORR; Percentage of Participants With Confirmed Response (CR + PR), as Assessed by RECIST Version 1.1 [ Time Frame: From first dose of study drug until first CR or PR (up to approximately 5.3 years) ]
- Progression-Free Survival (PFS); Time From the Date of First Dose Until the Date of PD or Death by Any Cause, as Defined by RECIST Version 1.1 [ Time Frame: From first dose of study drug until the date of PD or death by any cause (up to approximately 5.3 years) ]
- Duration of Response (DOR); the Time From First Objective Response (CR/PR) to the Time of PD Among Those who Have Achieved a PR or CR [ Time Frame: From the date of first objective response to the time of PD (up to approximately 5.3 years) ]
- Number of Participants With Gynecologic Cancer Intergroup (GCIG) CA125 Clinical Response [ Time Frame: Baseline up to approximately 5.3 years ]
- PK Parameter: Maximum Plasma Concentration (Cmax) of Intact Mirvetuximab Soravtansine Antibody Drug Conjugate (ADC), Total Antibody, N2'-[4-[(3-carboxypropyl)dithio]-4-methyl-1-oxo-2-sulfopentyl]-N2'-deacetylmaytansine (DM4), and S-methyl DM4 [ Time Frame: Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of end of infusion [EOI], and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (additionally at Day 22 for Regimen C) ]
- PK Parameter: Area Under the Time-Concentration Curve (AUC) of Intact Mirvetuximab Soravtansine ADC, Total Antibody, DM4, and S-methyl DM4 [ Time Frame: Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of EOI, and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (additionally at Day 22 for Regimen C) ]
- PK Parameter: Terminal Half-Life (t½) of Intact Mirvetuximab Soravtansine ADC, Total Antibody, DM4, and S-methyl DM4 [ Time Frame: Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of EOI, and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (additionally at Day 22 for Regimen C) ]
- PK Parameter: Clearance (CL) of Intact Mirvetuximab Soravtansine ADC, Total Antibody, DM4, and S-methyl DM4 [ Time Frame: Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of EOI, and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (additionally at Day 22 for Regimen C) ]
- PK Parameter: Volume of Distribution at Steady State (Vss) of Intact Mirvetuximab Soravtansine ADC, Total Antibody, DM4, and S-methyl DM4 [ Time Frame: Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of EOI, and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (additionally at Day 22 for Regimen C) ]
- PK Parameter: Time to Reach Cmax (Tmax) of Intact Mirvetuximab Soravtansine ADC, Total Antibody, DM4, and S-methyl DM4 [ Time Frame: Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of EOI, and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (additionally at Day 22 for Regimen C) ]
- Concentration of Bevacizumab, Carboplatin, and Pegylated Liposomal Doxorubicin [ Time Frame: Bevacizumab and Pegylated Liposomal Doxorubicin: Cycles 1 to 6: Day 1 (pre-infusion, within 10 minutes of EOI); Carboplatin: Cycles 1, 2, 3, 4, 5, 6: Day 1 (pre-infusion, within 10 minutes of EOI; Cycles 1, 3: Days 1 and 2 (6- and 24-hours post-infusion) ]
- Immunogenicity: Number of Participants With Anti-Drug Antibody (ADA) to Mirvetuximab Soravtansine [ Time Frame: Baseline up to approximately 5.3 years ]

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, Learn About Clinical Studies.
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
- FRα positive tumor expression as defined in the protocol
- Willing to provide an archival tumor tissue block or slides or undergo tumor biopsy. New tumor biopsy (Cycle 2 Day 8) is required for Regimen D.
- Measurable disease
Exclusion Criteria:
- Primary platinum-refractory disease
- Diagnosis of clear cell, low grade ovarian cancer or mixed tumors
- Serious concurrent illness or clinically relevant active infection, including but not limited to known diagnosis of human immunodeficiency virus (HIV) and hepatitis B or C, as defined in the protocol
- Active autoimmune disease requiring systemic therapy in past 2 years (for Regimen D only)
- Women who are pregnant or breastfeeding
- Male participants

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 |
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: | December 17, 2021 |
Last Verified: | December 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 Maytansine Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors |