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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
NCT06682988 · AbbVie
In plain English
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Official title
A Randomized Phase 2, Open-label Study of Mirvetuximab Soravtansine in Patients With Platinum-resistant Advanced High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-alpha Expression Testing 2 Schedules of Administration for Dose Optimization, With a Separate Cohort to Determine Starting Dose in Patients With Moderate Hepatic Impairment
About this study
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.
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 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.
Study design
Enrollment target: 110 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-05-28
Estimated completion: 2028-04
Last updated: 2026-05-26
Interventions
Drug: Mirvetuximab Soravtansine
Primary outcomes
- • Randomized Phase 2 Cohort: Percentage of Participants with Grade >= 2 Treatment-Emergent Corneal Adverse Events (AEs) (Up to Approximately 24 months)
- • Randomized Phase 2 Cohort: Percentage of Participants who Achieved Objective response rate (ORR) (Up to Approximately 24 months)
- • Hepatic Impairment Cohort: Maximal Concentration (Cmax) of Mirvetuximab Soravtansine (Up to Approximately 24 months)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (52)
First Physicians Group /ID# 272180Recruiting
Sarasota, Florida, United States
St. Elizabeth Medical Center - Edgewood /ID# 272113Recruiting
Edgewood, Kentucky, United States
Baptist Health Lexington /ID# 272211Recruiting
Lexington, Kentucky, United States
UMass Memorial Medical Center - Belmont Street /ID# 272122Recruiting
Worcester, Massachusetts, United States
Karmanos Cancer Institute - Detroit /ID# 272112Recruiting
Detroit, Michigan, United States
Allegheny Health Network West Penn Hospital /ID# 272267Recruiting
Pittsburgh, Pennsylvania, United States
Memorial Hermann Texas Medical Center /ID# 272227Recruiting
Houston, Texas, United States
Blacktown Hospital /ID# 272182Recruiting
Blacktown, New South Wales, Australia
Newcastle Private Hosptial /ID# 272213Recruiting
Lambton Heights, New South Wales, Australia
Royal Brisbane and Women's Hospital /ID# 272123Recruiting
Brisbane, Queensland, Australia
Icon Cancer Centre Chermside /ID# 272220Recruiting
Chermside, Queensland, Australia
Ballarat Base Hospital /ID# 272240Recruiting
Ballarat, Victoria, Australia
Monash Health - Monash Medical Centre - Clayton /ID# 272234Recruiting
Clayton, Victoria, Australia
Sir Charles Gairdner Hospital /ID# 272116Recruiting
Nedlands, Western Australia, Australia
Algemeen Ziekenhuis klina /ID# 272127Recruiting
Brasschaat, Antwerpen, Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 272219Recruiting
Brussels, Brussels Capital, Belgium
AZ Maria Middelares /ID# 272186Recruiting
Ghent, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 277350Recruiting
Leuven, Vlaams-Brabant, Belgium
AZ-Delta /ID# 272250Recruiting
Roeselare, West-Vlaanderen, Belgium
Centre Francois Baclesse /ID# 272204Recruiting
Caen, Calvados, France
Centre Armoricain De Radiothérapie, D'Imagerie Médicale Et D'Oncologie (Cario) /ID# 272201Recruiting
Plérin, Cotes-d Armor, France
Institut De Cancérologie De Lorraine Alexis Vautrin /ID# 272147Recruiting
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
Centre Oscar Lambret /ID# 272183Recruiting
Lille, Nord, France
Centre Antoine-Lacassagne /ID# 272101Recruiting
Nice, Provence-Alpes-Côte d'Azur Region, France
HCL - Hopital Lyon Sud /ID# 272178Recruiting
Pierre-Bénite, Rhone, France
Centre Hospitalier Departemental Vendee (Chd Vendee) /ID# 272174Recruiting
La Roche-sur-Yon, Vendee, France
GH Diaconesses Croix Saint Simon-Hopital De La Croix Saint-Simon /ID# 272179Recruiting
Paris, France
Mazowiecki Szpital Wojewodzki im. Sw. Jana Pawla II w Siedlcach Sp. z o.o. /ID# 271692Recruiting
Siedlce, Masovian Voivodeship, Poland
Bialostockie Centrum Onkologii im. M. Sklodowskiej-Curie w Bialymstoku /ID# 272169Recruiting
Bialystok, Podlaskie Voivodeship, Poland
National Cancer Center /ID# 272265Recruiting
Goyang-si, Gyeonggido, South Korea
CHA Bundang Medical Center /ID# 271590Recruiting
Seongnam, Gyeonggido, South Korea
Seoul National University Bundang Hospital /ID# 271594Recruiting
Seongnam-si, Gyeonggido, South Korea
Keimyung University Dongsan Hospital /ID# 271592Recruiting
Daegu, Gyeongsangbuk-do, South Korea
Seoul National University Hospital /ID# 272264Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 271593Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 272130Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Gangnam Severance Hospital /ID# 272217Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 271591Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Hospital Universitario Germans Trias i Pujol /ID# 272216Recruiting
Badalona, Barcelona, Spain
Hospital Universitario de Jaén /ID# 272205Recruiting
Jaén, Jaen, Spain
Hospital Clínico Universitario Virgen de la Arrixaca /ID# 272223Recruiting
El Palmar, Murcia, Spain
Clinica Universidad de Navarra - Pamplona /ID# 275742Recruiting
Pamplona, Navarre, Spain
Hospital Universitario Virgen del Rocio /ID# 272107Recruiting
Seville, Sevilla, Spain
Hospital Universitario Vall de Hebron /ID# 272134Recruiting
Barcelona, Spain
Hospital General Universitario Gregorio Maranon /ID# 272121Recruiting
Madrid, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 272221Recruiting
Madrid, Spain
Hospital Universitario HM Sanchinarro /ID# 272190Recruiting
Madrid, Spain
Hospital Clinico Universitario de Valencia /ID# 272218Recruiting
Valencia, Spain
Hospital Clinico Universitario Lozano Blesa /ID# 272165Recruiting
Zaragoza, Spain
Addenbrookes Hospital /ID# 272162Recruiting
Cambridge, Cambridgeshire, United Kingdom
Royal Devon and Exeter Hospital /ID# 272170Recruiting
Exeter, Devon, United Kingdom
University College London Hospital /ID# 272115Recruiting
London, Greater London, United Kingdom