A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression (MIRASOL)
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ClinicalTrials.gov Identifier: NCT04209855 |
Recruitment Status :
Active, not recruiting
First Posted : December 24, 2019
Last Update Posted : March 6, 2023
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Condition or disease | Intervention/treatment | Phase |
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Epithelial Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer | Drug: Mirvetuximab Soravtansine Drug: Paclitaxel Drug: Topotecan Drug: Pegylated liposomal doxorubicin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 453 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | MIRASOL: A Randomized, Open-label, Phase 3 Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression |
Actual Study Start Date : | December 31, 2019 |
Estimated Primary Completion Date : | September 2023 |
Estimated Study Completion Date : | April 2024 |

Arm | Intervention/treatment |
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Experimental: mirvetuximab soravtansine (MIRV; IMGN853)
MIRV 6 mg/kg adjusted ideal body weight (AIBW) every 3 weeks (Q3W)
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Drug: Mirvetuximab Soravtansine
Mirvetuximab soravtansine is an antibody drug conjugate designed to target folate receptor α (FRα). It consists of the humanized anti-FRα mAb M9346A attached via a cleavable disulfide linker to the cytotoxic maytansinoid, DM4.
Other Names:
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Active Comparator: Investigator's choice of chemotherapy
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Drug: Paclitaxel
Paclitaxel is a taxane that can stabilize microtubules to inhibit cell division. It was approved for treatment of recurrent epithelial ovarian cancer. Drug: Topotecan Topotecan induces irreversible DNA damage. It inhibits topoisomerase 1, leading to both single and double strand DNA break that eventually promote apoptosis. Topotecan was approved for treatment of epithelial ovarian cancer after failure of initial or subsequent chemotherapy. Drug: Pegylated liposomal doxorubicin Pegylated liposomal doxorubicin is a standard chemotherapy regimen used for treating platinum-resistant ovarian cancer. The active component doxorubicin is an anthracycline that intercalates DNA, leading to inhibition of replication and subsequently, the inhibition of proper cell division. |
- Progression-free survival (PFS) [ Time Frame: Up to 2 years ]The time from date of randomization until Investigator-assessed progressive disease or death, whichever occurs first.
- Safety and tolerability [ Time Frame: Up to 2 years ]Adverse events (AEs) will be evaluated according to the NCI CTCAE v5.0. AEs will be coded using the latest Medical Dictionary for Regulatory Activities (MedDRA) version and summarized per system organ class (SOC) and preferred term (PT).
- Objective Response Rate (ORR) [ Time Frame: Up to 2 years ]Objective response includes best response of complete response (CR) or partial response (PR).
- Overall survival [ Time Frame: Up to 2 years ]The time from date of randomization until the date of death
- Primary patient-reported outcomes [ Time Frame: Up to 2 years ]The number of patients achieving at least 15 point absolute improvement at Week 8 or Week 9 in the abdominal/GI scale of the European Organization for Research and Treatment of Cancer (EORTC) ovarian cancer specific quality of life questionnaire (QLQ-OV28). A higher score represents a better quality of life.
- Duration of response (DOR) [ Time Frame: Up to 2 years ]The time from initial response until Investigator-assessed progressive disease for all patients who achieve a confirmed objective response
- CA-125 response [ Time Frame: Up to 2 years ]Serum CA-125 response determined using the GCIG criteria
- Progression-free survival 2 (PFS 2) [ Time Frame: Up to 2 years ]The time from date of randomization until second disease progression or death whichever occurs first. Results will be summarized by arm
- Patient-reported outcomes using EORTC QLQ-C30 questionnaires [ Time Frame: Up to 2 years ]The EORTC QLQ-C30 questionnaires will be used to collect data on the patient's functioning, health-related QOL, disease symptoms and health status. A higher score represents a higher response level.
- Patient-reported outcomes using EQ-5D-5L questionnaires [ Time Frame: Up to 2 years ]The EuroQol-5 Dimension 5-level (EQ-5D-5L) questionnaires will be used to collect data on the patient's functioning, health-related QOL, disease symptoms and health status. A higher score represents a higher response level.
- Pharmacokinetic parameters [ Time Frame: Up to 2 years ]Plasma samples will be collected to determine the concentration of MIRV (antibody-drug conjugate, total antibody, free DM4, S-methyl DM4 and possibly other metabolites). Summary statistics of the concentration at each time point (nominal time) will be presented. Graphical presentation of the data may also be completed using nominal time.
- Immunogenicity [ Time Frame: Up to 2 years ]The presence of anti-drug antibodies to mirvetuximab soravtansine
- Identification of soluble FRα levels and other biomarkers [ Time Frame: Up to 2 years ]
- Patient-reported outcomes using PGIS questionnaires [ Time Frame: Up to 2 years ]The Patient Global Impression of Severity (PGIS) questionnaires will be used to collect data on the patient's perception of overall cancer symptom severity. This is a single question survey.

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 |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Female patients ≥ 18 years of age
- Patients must have a confirmed diagnosis of high-grade serious epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
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Patients must have platinum-resistant disease:
- Patients who have only had 1 line of platinum based therapy must have received at least 4 cycles of platinum, must have had a response (CR or PR) and then progressed between >3 months and ≤ 6 months after the date of the last dose of platinum
- Patients who have received 2 or 3 lines of platinum therapy must have progressed on or within 6 months after the date of the last dose of platinum Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression. Note: Patients who are platinum-refractory during front-line treatment are excluded
- Patients must have progressed radiographically on or after their most recent line of therapy
- Patients must be willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low risk, medically routine procedure for IHC confirmation of FRα positivity
- Patient's tumor must be positive for FRα expression as defined by the Ventana FOLR1 (FOLR-2.1) CDx assay
- Patients must have at least one lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the Investigator)
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Patients must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment:
- Adjuvant ± neoadjuvant considered one line of therapy
- Maintenance therapy (eg, bevacizumab, PARP inhibitors) will be considered as part of the preceding line of therapy (ie, not counted independently)
- Therapy changed due to toxicity in the absence of progression will be considered as part of the same line (ie, not counted independently)
- Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance
- Patient must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
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Time from prior therapy:
- Systemic antineoplastic therapy (5 half-lives or 4 weeks, whichever is shorter)
- Focal radiation completed at least 2 weeks prior to first dose of study drug
- Patients must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities
- Major surgery must be completed at least 4 weeks prior to first dose and have recovered or stabilized from the side effects of prior surgery
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Patients must have adequate hematologic, liver and kidney functions defined as:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1,500/μL) without G-CSF in the prior 10 days or long-acting WBC growth factors in the prior 20 days
- Platelet count ≥ 100 x 10^9/L (100,000/μL) without platelet transfusion in the prior 10 days
- Hemoglobin ≥ 9.0 g/dL without packed red blood cell (PRBC) transfusion in the prior 21 days
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN
- Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 x ULN
- Serum albumin ≥ 2 g/dL
- Patients or their legally authorized representative must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements
- Women of childbearing potential (WCBP) must agree to use highly effective contraceptive method(s) (as defined in Section 5.9.6 in the protocol) while on study drug and for at least 3 months after the last dose of MIRV or at least 6 months after the last dose of paclitaxel, pegylated liposomal doxorubicin, or topotecan
- WCBP must have a negative pregnancy test within 4 days prior to the first dose of study drug
Exclusion Criteria:
- Patients with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade or borderline ovarian tumor
- Patients with primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first line platinum-containing chemotherapy
- Patients with prior wide-field radiotherapy (RT) affecting at least 20% of the bone marrow
- Patients with > Grade 1 peripheral neuropathy per CTCAE v5.0
- Patients with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision
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Patients with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:
- Active hepatitis B or C infection (whether or not on active antiviral therapy)
- HIV infection
- Active cytomegalovirus infection
- Any other concurrent infectious disease requiring IV antibiotics within 2 weeks before starting study drug Note: Testing at screening is not required for the above infections unless clinically indicated
- Patients with history of multiple sclerosis or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
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Patients with clinically significant cardiac disease including, but not limited to, any one of the following:
- Myocardial infarction ≤ 6 months prior to first dose
- Unstable angina pectoris
- Uncontrolled congestive heart failure (New York Heart Association > class II)
- Uncontrolled ≥ Grade 3 hypertension (per CTCAE)
- Uncontrolled cardiac arrhythmias
- Patients assigned to PLD stratum only: Left ventricular ejection fraction (LVEF) below the institutional limit of normal as measured by echocardiography (ECHO) or multigated acquisition (MUGA) scan
- Patients with a history of hemorrhagic or ischemic stroke within six months prior to randomization
- Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)
- Patients with a previous clinical diagnosis of non-infectious interstitial lung disease (ILD), including noninfectious pneumonitis
- Patients with required use of folate-containing supplements (eg, folate deficiency)
- Patients with prior hypersensitivity to monoclonal antibodies
- Women who are pregnant or lactating
- Patients with prior treatment with MIRV or other FRα-targeting agents
- Patients with untreated or symptomatic central nervous system (CNS) metastases
- Patients with a history of other malignancy within 3 years prior to randomization. Note: does not include tumors with a negligible risk for metastasis or death (eg, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast
- Prior known hypersensitivity reactions to study drugs and/or any of their excipients
- People who are detained through a court or administrative decision, receiving psychiatric care against their will, adults who are the subject of a legal protection order (under tutorship/curatorship), people who are unable to express their consent, and people who are subject to a legal guardianship order
- Simultaneous participation in another research study, in countries or localities where this is the health authority guidance

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): NCT04209855

Study Director: | Michael Method, MPH, MBA | ImmunoGen, Inc. |
Responsible Party: | ImmunoGen, Inc. |
ClinicalTrials.gov Identifier: | NCT04209855 |
Other Study ID Numbers: |
IMGN853-0416 2019-003509-80 ( EudraCT Number ) |
First Posted: | December 24, 2019 Key Record Dates |
Last Update Posted: | March 6, 2023 |
Last Verified: | March 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Platinum-resistant Folate-receptor alpha expression Phase 3 Antibody-drug conjugate mirvetuximab soravtansine |
IMGN853 Epithelial Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer |
Ovarian Neoplasms Carcinoma, Ovarian Epithelial Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Neoplasms, Female Urogenital Neoplasms Genital Diseases |
Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Fallopian Tube Diseases Paclitaxel Maytansine Doxorubicin Liposomal doxorubicin Topotecan Mirvetuximab soravtansine Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators |