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 : Recruiting
First Posted : December 24, 2019
Last Update Posted : May 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|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)|
|Estimated Enrollment :||430 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||June 2022|
|Estimated Study Completion Date :||November 2022|
Experimental: mirvetuximab soravtansine (MIRV; IMGN853)
MIRV 6 mg/kg adjusted ideal body weight (AIBW) every 3 weeks (Q3W)
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.
Active Comparator: Investigator's choice of chemotherapy
Paclitaxel is a taxane that can stabilize microtubules to inhibit cell division. It was approved for treatment of recurrent epithelial ovarian cancer.
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 ]
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
|Contact: Elizabeth Noble||781-895-0176||Elizabeth.Noble@immunogen.com|
|Study Director:||Patrick A Zweidler-McKay, MD, PhD||ImmunoGen, Inc.|