Mirvetuximab Soravtansine for Platinum-Resistant Ovarian Cancer
A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
110 (estimated)
Sponsor
AbbVie · Industry
Who this trial is looking for
This trial is looking for patients with advanced ovarian cancer that has not responded well to previous platinum-based treatments. Participants will receive Mirvetuximab Soravtansine in a hospital or clinic and attend regular visits over approximately 24 months.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
I have platinum-resistant disease.
I have had at least one previous line of platinum-based therapy.
I had a response to treatment but my cancer got worse after a certain period.
I have measurable lesions as defined by the study.
I have a tumor that expresses folate receptor alpha.
I have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
You may not be able to join if
I have a different type of ovarian cancer, like endometrioid or clear cell.
I did not respond to my first line of platinum therapy.
I have a serious ongoing illness or active infection.
I had a stroke in the last 6 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer (platinum-resistant ovarian cancer) (PROC) whose tumors express a high level of fol…
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer (platinum-resistant ovarian cancer) (PROC) whose tumors express a high level of folate receptor alpha (FRα).
Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). There are 2 cohorts in this study, the Randomized Phase 2 Cohort and the Hepatic Impairment Cohort. In the Randomized Phase 2 Cohort, participants are placed in 1 of 2 groups, called treatment arms. Each treatment arm receives MIRV on a different schedule (on day 1 every 21 days or on days 1 and 15 every 28 days). The Hepatic Impairment Cohort is designed to determine the starting dose of MIRV in patients with moderately abnormal liver function. Around 110 participants will be enrolled in the study at approximately 75 sites worldwide.
The total study duration will be approximately 24 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Both Cohorts
* Participants with a confirmed diagnosis of high-grade serous epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.
* Participants with platinum-resistant disease:
* Participants with 1 prior line of platinum-based therapy who ha…
Inclusion Criteria:
Both Cohorts
* Participants with a confirmed diagnosis of high-grade serous epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.
* Participants with platinum-resistant disease:
* Participants with 1 prior line of platinum-based therapy who have received ≥ 4 cycles of platinum and had a response (complete response (CR) or partial response (PR)) followed by radiological progressive disease (PD) between \> 3 months and ≤ 6 months after the date of the last dose of platinum.
* Participants with 2 or 3 prior lines of platinum-based therapy who had radiological PD ≤ 6 months after the date of the last dose of platinum.
* Participants with progression diagnosed radiographically on or after their most recent line of therapy.
* Participants with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
* Participants with ≥ 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the investigator).
* Participants with a tumor that is positive for folate receptor alpha (FRα) expression as determined by the Ventana folate receptor 1 (FOLR1) assay (≥ 75% of tumor staining at 2+ intensity).
Exclusion Criteria:
Both Cohorts
* Participants with endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors containing any of the above histologies; or low-grade or borderline ovarian tumor.
* Participants with primary platinum-refractory disease, defined as disease that did not respond (complete response (CR) or partial response (PR)) or that progressed radiographically within 3 months of the last dose of first-line platinum-containing chemotherapy.
* Participants with serious concurrent illness or clinically relevant active infection as outlined in the protocol
* Participants with a history of hemorrhagic or ischemic stroke within 6 months prior to randomization.
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