A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression (SORAYA)
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|ClinicalTrials.gov Identifier: NCT04296890|
Recruitment Status : Recruiting
First Posted : March 5, 2020
Last Update Posted : September 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Epithelial Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer||Drug: Mirvetuximab Soravtansine||Phase 3|
This study is designed to evaluate the efficacy and safety of mirvetuximab soravtansine (MIRV) in patients with platinum-resistant high-grade serous epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of Folate Receptor Alpha (FRα). Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. FRα positivity will be defined by the Ventana FOLR1 (Folate Receptor 1/Folate Receptor Alpha) Assay.
Approximately 110 eligible patients will be enrolled to achieve a total of 105 efficacy evaluable patients. Efficacy evaluable patients include those who have measurable lesions per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) at baseline and received at least 1 dose of MIRV.
All patients will receive single-agent MIRV at 6 mg/kg adjusted ideal body weight (AIBW) administered on Day 1 of every 3-week cycle (Q3W).
Tumor response will be evaluated by the Investigator using RECIST v1.1. Computerized tomography (CT) or magnetic resonance imaging (MRI) scans will be collected for sensitivity analysis by blinded independent central review (BICR).
Patients will continue to receive MIRV until disease progression, unacceptable toxicity, withdrawal of consent, death, or until the Sponsor terminates the study (whichever comes first).
Tumor assessments, including radiological assessments by CT/MRI scans will be performed at Screening and subsequently every 6 weeks (± 1 week) from Cycle 1 Day 1 (C1D1) for the first 36 weeks then every 12 weeks (± 3 weeks) until disease progression, death, the start of new anticancer therapy, or patient's withdrawal of consent (whichever occurs first).
Patients who discontinue MIRV for reasons other than progressive disease (PD) will continue with tumor assessments until documentation of PD or the start of a new anticancer therapy, whichever comes first. Prior to Week 36 (from Cycle 1, Day 1), assessments should occur every 6 weeks (± 1 week) as allowed by local requirements but must occur at an interval of no more than 12 weeks. After Week 36, assessment will occur every 12 weeks (± 3 weeks) until documentation of PD or the start of new anticancer therapy.
All patients who discontinue MIRV will be followed for survival every 3 months (± 1 month) until death, lost to follow-up, withdrawal of consent for survival follow-up, or end of study (EOS) (whichever comes first). Additional survival follow-up calls may occur periodically, if needed.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All patients will receive single-agent MIRV at 6 mg/kg adjusted ideal body weight (AIBW) administered on Day 1 of every 3-week cycle (Q3W)|
|Masking:||None (Open Label)|
|Official Title:||SORAYA: A Phase 3, Single Arm Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression|
|Actual Study Start Date :||July 23, 2020|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2022|
All patients will receive single-agent mirvetuximab soravtansine (MIRV) at 6 mg/kg adjusted ideal body weight (AIBW) administered on Day 1 of every 3-week cycle (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.
- Objective Response Rate (ORR) [ Time Frame: Up to 2 years ]Objective response rate (ORR), which includes best response of complete response (CR) or partial response (PR) as assessed by the Investigator.
- Duration of Response (DOR) [ Time Frame: Up to 2 years ]The time from initial Investigator-assessed response (CR or PR) until progressive disease (PD) as assessed by the Investigator
- Adverse Events (AEs) [ Time Frame: Up to 2 years ]Adverse Events (AE's) will be evaluated according to the NCI CTCAE v5.0. AE's will be coded using the latest Medical Dictionary for Regulatory Activities (MedDRA) version and summarized per system organ class (SOC) and preferred term (PT).
- Progression-Free Survival (PFS) [ Time Frame: Up to 2 years ]The time from first dose of MIRV until Investigator-assessed radiological progressive disease (PD) or death, whichever occurs first.
- Overall Survival (OS) [ Time Frame: Up to 2 years ]The time from first dose of MIRV until death.
- CA-125 Response [ Time Frame: Up to 2 years ]Serum CA-125 response determined using the Gynecologic Cancer Intergroup (GCIG) criteria.
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): NCT04296890
|Contact: Elizabeth Noble||781-895-0176||Elizabeth.Noble@immunogen.com|
|Study Director:||Patrick A Zweidler-McKay, MD, PhD||ImmunoGen, Inc.|
|Principal Investigator:||Ursula Matulonis, MD||Dana-Farber Cancer Institute|
|Principal Investigator:||Robert Coleman, MD||The US Oncology Network|