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Looking for participantsPhase2

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

Sponsor: AbbVie

NCT ID: NCT06682988

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Mirvetuximab Soravtansine (drug)
How long the study runs
Study runs about 35 months (dates as stated)
About the drug or intervention
Mirvetuximab Soravtansine — drug: intravenous (IV) infusion
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at a drug called mirvetuximab soravtansine, given through a drip into a vein (an intravenous infusion). It is for people with advanced high-grade ovarian, primary peritoneal, or fallopian tube cancer that has stopped responding to platinum chemotherapy, and whose cancer cells show high levels of a protein called folate receptor alpha. The study will look at side effects and whether the drug changes disease activity.

Who can take part

  • A confirmed diagnosis of high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
  • Cancer that is resistant to platinum chemotherapy. This means either: one previous course of platinum treatment with at least 4 cycles, where the cancer shrank at first but then got worse between more than 3 months and up to 6 months after the last platinum dose; or two or three previous courses of platinum treatment where the cancer got worse within 6 months of the last dose.
  • Worsening of the cancer shown on a scan during or after the most recent treatment.
  • Being well enough for everyday activity (a performance status score of 0 or 1 on a scale used by doctors called the Eastern Cooperative Oncology Group Performance Status).
  • At least one tumour that can be measured on a scan (using standard guidelines called RECIST version 1.1).
  • A tumour that tests positive for a protein called folate receptor alpha, using a specific laboratory test. This means at least 75% of the tumour cells stain at a certain strength (2+) on the test.

Who may not be able to

  • Certain types of tumour: endometrioid, clear cell, mucinous, or sarcomatous types; mixed tumours containing any of these; or low-grade or borderline ovarian tumours.
  • Cancer that never responded to the first platinum chemotherapy or got worse within 3 months of the last dose (called platinum-refractory disease).
  • A serious other illness or a significant active infection, as set out in the study plan.
  • A bleed or blockage of blood supply in the brain (a haemorrhagic or ischaemic stroke) within the 6 months before joining the study.

What taking part involves

  • • Receiving the study drug, mirvetuximab soravtansine, through a drip into a vein (intravenous infusion).
  • • Tests to check side effects and any change in disease activity during the study.

Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
Female
Number of participants
110
Started
2025-05-28
Last checked
2026-05

Plain English Summary

What is this study?

  • • Testing a new treatment for advanced high-grade epithelial ovarian cancer
  • • Phase2 - 110 participants
  • • Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with advanced high-grade epithelial ovarian cancer
  • • Female only

Where?

  • • Cambridge - Addenbrookes Hospital /ID# 272162
  • • Exeter - Royal Devon and Exeter Hospital /ID# 272170
  • • London - University College London Hospital /ID# 272115

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Advanced High-Grade Epithelial Ovarian CancerPrimary Peritoneal CancerFallopian Tube Cancers

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Female only

Biomarkers mentioned

PRthat is positive

Treatment history

Treatments you must have had:

  • ✓ of platinum-based therapy who have received ≥ 4 cycles of platinum

What the study is looking for

  • ✓Both Cohorts
  • ✓Participants with a confirmed diagnosis of high-grade serous epithelial ovarian cancer (EOC), primary peritoneal...
  • ✓Participants with platinum-resistant disease:
  • ✓Participants with 2 or 3 prior lines of platinum-based therapy who had radiological PD ≤ 6 months after the date of...
  • ✓Participants with progression diagnosed radiographically on or after their most recent line of therapy.

Who cannot take part

  • ✗Both Cohorts
  • ✗Participants with endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors containing any of the...
  • ✗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.
See the full 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 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.

Where Is This Study? (3 UK sites)

Addenbrookes Hospital /ID# 272162

Cambridge CB2 2QQ, United Kingdom

Recruiting

Royal Devon and Exeter Hospital /ID# 272170

Exeter EX2 5DW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Samantha Smart

rduh.research-eastern@nhs.net01392 406075

University College London Hospital /ID# 272115

London NW1 2BU, United Kingdom

Recruiting

How to Get in Touch

ABBVIE CALL CENTER

Sponsor contact

CONTACT

844-663-3742 abbvieclinicaltrials@abbvie.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-05