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 | Recruiting Phase 2 FDA Drug

• 1 other identifier: IMGN853-0425
• Study Type: interventional
• Target: 110
• Locations: 6 countries
• Sites: 37

Brief Summary

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.

Conditions

Advanced High-Grade Epithelial Ovarian; Primary Peritoneal; Fallopian Tube Cancers; High Folate Receptor-Alpha Expression; Platinum Resistant

Keywords

Advanced High-Grade Epithelial Ovarian; Primary Peritoneal; Fallopian Tube Cancers; High Folate Receptor-Alpha Expression; Platinum Resistant; Mirvetuximab Soravtansine; MIRV; IMGN853

Outcome Measures

Primary Outcomes (8)

• Randomized Phase 2 Cohort: Percentage of Participants with Grade >= 2 Treatment-Emergent Corneal Adverse Events (AEs)

  An AE is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related.

  Up to Approximately 24 months

• Randomized Phase 2 Cohort: Objective response rate (ORR)

  ORR is defined as best response of confirmed complete response (CR) or partial response (PR), as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

  Up to Approximately 24 months

• Hepatic Impairment Cohort: Maximal Concentration (Cmax) of Mirvetuximab Soravtansine

  Cmax of MIRV

  Up to Approximately 24 months

• Hepatic Impairment Cohort: Area Under the Plasma Concentration (AUC) of Mirvetuximab Soravtansine

  AUC of MIRV

  Up to Approximately 24 months

• Hepatic Impairment Cohort: Trough Concentration (Ctrough) of Mirvetuximab Soravtansine

  Ctrough of MIRV

  Up to Approximately 24 months

• Hepatic Impairment Cohort: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine

  Vss) of MIRV

  Up to Approximately 24 months

• Hepatic Impairment Cohort: Time to Maximal Concentration (Tmax) of Mirvetuximab Soravtansine

  Tmax of MIRV

  Up to Approximately 24 months

• Hepatic Impairment Cohort: Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine

  t1/2 of MIRV

  Up to Approximately 24 months

Secondary Outcomes (16)

• Randomized Phase 2 Cohort: Percentage of Participants with Treatment-Emergent All-Grade Ocular AEs, Grade >= 2 Peripheral Neuropathy, All-Grade Infusion Reactions, and All-Grade Pneumonitis

  Up to Approximately 24 months

• Randomized Phase 2 Cohort: Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1

  Up to Approximately 24 months

• Randomized Phase 2 Cohort: Progression-Free Survival (PFS)

  Up to Approximately 24 months

• Randomized Phase 2 Cohort: Overall Survival (OS)

  Up to Approximately 24 months

• Randomized Phase 2 Cohort: Percentage of Participants With CA-125 Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria

  Up to Approximately 24 months

Study Arms (3)

Randomized Phase 2 Cohort: Arm A

EXPERIMENTAL

Participants will receive Mirvetuximab Soravtansine at the standard dose on Day 1 of a 21-day cycle.

Drug: Mirvetuximab Soravtansine

Randomized Phase 2 Cohort: Arm B

EXPERIMENTAL

Participants will receive Mirvetuximab Soravtansine at a lower dose than the standard dose on Day 1 and Day 15 of a 28-day cycle .

Drug: Mirvetuximab Soravtansine

Hepatic Impairment Cohort : Mirvetuximab Soravtansine

EXPERIMENTAL

Participants will receive Mirvetuximab Soravtansine on Day 1 of a 21-day cycle. Different doses will be given to groups of patients to identify a safe and effective dose.

Drug: Mirvetuximab Soravtansine

Interventions

Mirvetuximab Soravtansine DRUG

intravenous (IV) infusion

Also known as: MIRV, IMGN853

Hepatic Impairment Cohort : Mirvetuximab Soravtansine; Randomized Phase 2 Cohort: Arm A; Randomized Phase 2 Cohort: Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (37)

First Physicians Group /ID# 272180

Sarasota, Florida, 34239, United States

RECRUITING

St. Elizabeth Medical Center - Edgewood /ID# 272113

Edgewood, Kentucky, 41017, United States

RECRUITING

Baptist Health Lexington /ID# 272211

Lexington, Kentucky, 40503, United States

RECRUITING

UMass Memorial Medical Center /ID# 272122

Worcester, Massachusetts, 01605, United States

RECRUITING

Karmanos Cancer Institute - Detroit /ID# 272112

Detroit, Michigan, 48201, United States

RECRUITING

Allegheny Health Network West Penn Hospital /ID# 272267

Pittsburgh, Pennsylvania, 15244, United States

RECRUITING

Blacktown Hospital /ID# 272182

Blacktown, New South Wales, 2148, Australia

RECRUITING

Newcastle Private Hosptial /ID# 272213

Lambton Heights, New South Wales, 2305, Australia

RECRUITING

Royal Brisbane and Women's Hospital /ID# 272123

Brisbane, Queensland, 4029, Australia

RECRUITING

Icon Cancer Centre Chermside /ID# 272220

Chermside, Queensland, 4032, Australia

RECRUITING

Ballarat Base Hospital /ID# 272240

Ballarat, Victoria, 3350, Australia

RECRUITING

Monash Health - Monash Medical Centre /ID# 272234

Clayton, Victoria, 3168, Australia

RECRUITING

Sir Charles Gairdner Hospital /ID# 272116

Nedlands, Western Australia, 6009, Australia

RECRUITING

Algemeen Ziekenhuis klina /ID# 272127

Brasschaat, Antwerpen, 2930, Belgium

RECRUITING

AZ Maria Middelares /ID# 272186

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

AZ-Delta /ID# 272250

Roeselare, West-Vlaanderen, 8800, Belgium

RECRUITING

National Cancer Center /ID# 272265

Goyang-si, Gyeonggido, 10408, South Korea

RECRUITING

CHA Bundang Medical Center /ID# 271590

Seongnam, Gyeonggido, 13496, South Korea

RECRUITING

Seoul National University Bundang Hospital /ID# 271594

Seongnam-si, Gyeonggido, 13620, South Korea

RECRUITING

Keimyung University Dongsan Hospital /ID# 271592

Daegu, Gyeongsangbuk-do, 42601, South Korea

RECRUITING

Seoul National University Hospital /ID# 272264

Seoul, Seoul Teugbyeolsi, 03080, South Korea

RECRUITING

Yonsei University Health System Severance Hospital /ID# 271593

Seoul, Seoul Teugbyeolsi, 03722, South Korea

RECRUITING

Asan Medical Center /ID# 272130

Seoul, Seoul Teugbyeolsi, 05505, South Korea

RECRUITING

Gangnam Severance Hospital /ID# 272217

Seoul, Seoul Teugbyeolsi, 06273, South Korea

RECRUITING

Samsung Medical Center /ID# 271591

Seoul, Seoul Teugbyeolsi, 06351, South Korea

RECRUITING

Hospital Universitario Germans Trias i Pujol /ID# 272216

Badalona, Barcelona, 08916, Spain

RECRUITING

Hospital Universitario de Jaén /ID# 272205

Jaén, Jaen, 23007, Spain

RECRUITING

Clinica Universidad de Navarra - Pamplona /ID# 275742

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Universitario Virgen del Rocio /ID# 272107

Seville, Sevilla, 41013, Spain

RECRUITING

Hospital Universitario Vall de Hebron /ID# 272134

Barcelona, 08035, Spain

RECRUITING

Hospital General Universitario Gregorio Maranon /ID# 272121

Madrid, 28007, Spain

RECRUITING

CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 272221

Madrid, 28027, Spain

RECRUITING

Hospital Universitario HM Sanchinarro /ID# 272190

Madrid, 28050, Spain

RECRUITING

Hospital Clinico Universitario Lozano Blesa /ID# 272165

Zaragoza, 50009, Spain

RECRUITING

Addenbrookes Hospital /ID# 272162

Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

RECRUITING

Royal Devon & Exeter Hospital /ID# 272170

Exeter, Devon, EX2 5DW, United Kingdom

RECRUITING

University College London Hospital /ID# 272115

London, Greater London, NW1 2BU, United Kingdom

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Fallopian Tube Neoplasms

Interventions

mirvetuximab soravtansine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 12, 2024
• Study Start: May 28, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

AU (7); US (6); KR (9); ES (9); BE (3); GB (3)