A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression

NCT06365853 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: IMGN853-04242023-505617-24-00
• Study Type: interventional
• Target: 100
• Locations: 7 countries
• Sites: 40

Brief Summary

The purpose of this study is to evaluate the incidence rate and severity of prespecified mirvetuximab soravtansine (MIRV)-related ocular treatment-emergent adverse events (TEAEs) and assess prophylaxis strategies in all participants (symptomatic and asymptomatic) undergoing prospective ophthalmic evaluation with recurrent ovarian cancer (participants with either platinum-sensitive ovarian cancer \[PSOC\] or platinum-resistant ovarian cancer \[PROC\]) with high folate receptor alpha (FRα) expression.

Conditions

Recurrent Ovarian Cancer; Folate Receptor-Alpha Positive

Outcome Measures

Primary Outcomes (1)

• Number of Participants With MIRV-related Corneal TEAEs (≥ Grade 2) in Asymptomatic Participants

  This endpoint will be assessed in the participants receiving MIRV who are asymptomatic .

  Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

Secondary Outcomes (9)

• Number of Participants With Ocular symptom TEAEs in Participants Using Corticosteroid or Vasoconstricting Eye Drop Primary Prophylaxis

  Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days

• Number of Participants With MIRV-related Corneal TEAEs in Symptomatic Participants

  Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

• Number of Participants With Ocular exam TEAEs in Asymptomatic Participants and Symptomatic participants

  Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

• Number of Participants With MIRV-related Corneal TEAEs (≥ Grade 2) in Participants Using Corticosteroid or Vasoconstricting Eye Drop Primary Prophylaxis

  Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

• Number of Participants with ocular exam TEAEs in Participants using corticosteroid or vasoconstricting eye drop primary prophylaxis

  Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

Study Arms (2)

Primary Prophylactic Steroid Eye Drops

EXPERIMENTAL

Prednisolone acetate ophthalmic suspension 1% 6 times daily on Days -1 to 4 and 4 times daily (QID) on Days 5 to 8 of each cycle; Lubricating eye drops QID throughout the entire cycle (doses should follow steroid dosing, when given, by approximately 15 minutes); MIRV 6 milligrams (mg)/kilogram (kg) adjusted ideal body weight (AIBW) every 3 weeks (Q3W) on Day 1 of each cycle. Each cycle length = 21 days.

Drug: Mirvetuximab Soravtansine; Drug: Lubricating Eye Drops; Drug: Prednisolone acetate ophthalmic suspension 1% eye drops

Primary Prophylactic Vasoconstricting Eye Drops

EXPERIMENTAL

Primary prophylactic brimonidine tartrate ophthalmic solution eye drops 3 times daily (TID) on Days 1 to 8 of each cycle (vasoconstricting drops should be started on the day of first infusion and should begin before the first infusion on Cycle 1 Day 1); Lubricating eye drops QID throughout the entire cycle (doses should follow brimonidine dosing, when given, by approximately 15 minutes); MIRV 6 mg/kg AIBW Q3W on Day 1 of each cycle. Each cycle length = 21 days.

Drug: Mirvetuximab Soravtansine; Drug: Lubricating Eye Drops; Drug: Brimonidine tartrate ophthalmic solution eye drops

Interventions

Lubricating Eye Drops DRUG

Lubricating artificial tears should be administered at least 15 minutes after corticosteroid or brimonidine eye drop administration.

Primary Prophylactic Steroid Eye Drops; Primary Prophylactic Vasoconstricting Eye Drops

Brimonidine tartrate ophthalmic solution eye drops DRUG

Self-administration of brimonidine tartrate ophthalmic solution eye drops as prescribed by the treating physician.

Primary Prophylactic Vasoconstricting Eye Drops

Mirvetuximab Soravtansine DRUG

Mirvetuximab soravtansine is an antibody drug conjugate designed to target folate receptor α (FRα). It consists of the humanized anti-FRα monoclonal antibody (mAb) M9346A attached via a cleavable disulfide linker to the cytotoxic maytansinoid, DM4.

Also known as: IMGN853, MIRV

Primary Prophylactic Steroid Eye Drops; Primary Prophylactic Vasoconstricting Eye Drops

Prednisolone acetate ophthalmic suspension 1% eye drops DRUG

Self-administration of prednisolone acetate ophthalmic suspension 1% eye drops as prescribed by the treating physician.

Primary Prophylactic Steroid Eye Drops

Eligibility Criteria

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

You may qualify if:

• Participants must have a confirmed diagnosis of epithelial ovarian, fallopian tube, and primary peritoneal cancer (EOC) with high FRα expression.
• Participant's tumor must be FRα positive (FRα high) as defined by either the VENTANA FOLR1 (FOLR-2.1) IUO Assay, or the VENTANA FOLR1 ( FOLR1-2.1) RxDx Assay (hereafter collectively termed VENTANA FOLR1 Assay) (≥ 75% cells exhibit ≥ 2+ membrane staining intensity).
• Participants with known breast cancer susceptibility gene (BRCA) mutations (tumor or germline) must have received poly (ADP-ribose) polymerase inhibitors (PARPi).
• Participants must have completed prior therapy within the specified times below:
• Systemic antineoplastic therapy ≥ 5 half-lives or 4 weeks (whichever is shorter) before first dose of MIRV;
• Focal radiation completed ≥ 2 weeks before the first dose of MIRV.
• Participants must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia).
• Women of childbearing potential (WOCBP) must agree to use highly effective contraceptive method(s) while on MIRV and for ≥ 7 months after the last dose; and must have a negative pregnancy test ≤ 4 days before the first dose of MIRV.

You may not qualify if:

• Participants with borderline ovarian tumor or non-epithelial histology or mixed histology including borderline or non-epithelial histology will be excluded.
• PROC participants with primary platinum-refractory disease, defined as disease that did not respond to (complete response \[CR\] or partial response \[PR\]) or progressed within ≤ 3 months of the last dose of first line platinum-containing chemotherapy.
• Participants with \> Grade 1 peripheral neuropathy per National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0).
• Participants with significant active or chronic corneal disorders (for example, corneal dystrophies, degenerations, limbal stem cell deficiency), history of corneal transplantation, significant ocular inflammatory conditions (for example, active or recurrent uveitis), or other active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, active diabetic retinopathy with macular edema, macular degeneration requiring treatment ≤ 90 days before first dose, presence of papilledema, best corrected visual acuity (BCVA) worse than 20/70 in either eye, or monocular vision.
• Participants receiving corticosteroid or vasoconstricting eyedrops at baseline or within 5 weeks of Cycle 1 Day 1.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (40)

University of California Los Angeles /ID# 269339

Los Angeles, California, 90095, United States

RECRUITING

Norton Cancer Institute - St. Matthews /ID# 269070

Louisville, Kentucky, 40207, United States

COMPLETED

Holy Cross Hospital - Silver Spring /ID# 269344

Silver Spring, Maryland, 20910, United States

RECRUITING

Mercy David C. Pratt Cancer Center /ID# 269350

St Louis, Missouri, 63141, United States

RECRUITING

The Center Of Hope /ID# 269348

Reno, Nevada, 89511, United States

ACTIVE NOT RECRUITING

Holy Name Medical Center /ID# 269340

Teaneck, New Jersey, 07666, United States

RECRUITING

New York Oncology Hematology - Albany Cancer Center /ID# 269345

Albany, New York, 12206-5013, United States

COMPLETED

Women'S Cancer Care Associates /ID# 269980

Albany, New York, 12208, United States

COMPLETED

Duke Cancer Institute /ID# 269342

Durham, North Carolina, 27710, United States

RECRUITING

Summa Health /ID# 269349

Akron, Ohio, 44304-1407, United States

RECRUITING

UT Southwestern Medical Center /ID# 269341

Dallas, Texas, 75390, United States

RECRUITING

Memorial Hermann Southeast Hospital /ID# 269347

Houston, Texas, 77089, United States

RECRUITING

Blacktown Hospital /ID# 269305

Blacktown, New South Wales, 2148, Australia

ACTIVE NOT RECRUITING

Newcastle Private Hosptial /ID# 269306

Lambton Heights, New South Wales, 2305, Australia

ACTIVE NOT RECRUITING

Monash Health - Monash Medical Centre /ID# 269304

Clayton, Victoria, 3168, Australia

ACTIVE NOT RECRUITING

Universitair Ziekenhuis Antwerpen /ID# 269310

Edegem, Antwerpen, 2650, Belgium

COMPLETED

OLV Ziekenhuis Aalst /ID# 269311

Aalst, Oost-Vlaanderen, 9300, Belgium

ACTIVE NOT RECRUITING

AZ Sint-Lucas /ID# 269307

Ghent, Oost-Vlaanderen, 9000, Belgium

ACTIVE NOT RECRUITING

UZ Gent /ID# 269309

Ghent, Oost-Vlaanderen, 9000, Belgium

COMPLETED

Universitair Ziekenhuis Leuven /ID# 269308

Leuven, Vlaams-Brabant, 3000, Belgium

ACTIVE NOT RECRUITING

CHU de Liege /ID# 269312

Liège, 4000, Belgium

COMPLETED

Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 268862

Montreal, Quebec, H1T 2M4, Canada

ACTIVE NOT RECRUITING

Hospital Notre-Dame Du Centre Hospitalier De L'Universite De Montreal /ID# 269314

Montreal, Quebec, H2L 4M1, Canada

ACTIVE NOT RECRUITING

McGill University Health Centre - Glen Site. /ID# 269313

Montreal, Quebec, H4A 3J1, Canada

ACTIVE NOT RECRUITING

Institut Paoli-Calmettes /ID# 269648

Marseille, Bouches-du-Rhone, 13273, France

ACTIVE NOT RECRUITING

Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 269301

Tours, Indre-et-Loire, 37000, France

ACTIVE NOT RECRUITING

Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 269330

Paris, Paris, 75679, France

ACTIVE NOT RECRUITING

Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud /ID# 269327

Pierre-Bénite, Rhone, 69310, France

ACTIVE NOT RECRUITING

Clinique Victor Hugo Le Mans /ID# 269985

Le Mans, Sarthe, 72000, France

ACTIVE NOT RECRUITING

GH Diaconesses Croix Saint-Simon /ID# 269329

Paris, 75020, France

ACTIVE NOT RECRUITING

Mater Misericordiae University Hospital /ID# 269334

Dublin, D07 R2WY, Ireland

ACTIVE NOT RECRUITING

Beaumont Hospital /ID# 268864

Dublin, D09 XR63, Ireland

COMPLETED

Hospital San Pedro de Alcántara /ID# 269320

Cáceres, Caceres, 10003, Spain

ACTIVE NOT RECRUITING

Hospital Universitario de Jaén /ID# 269319

Jaén, Jaen, 23007, Spain

ACTIVE NOT RECRUITING

Usp Instituto Universitario Dexeus /ID# 269322

Barcelona, 08028, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Vall de Hebron /ID# 269315

Barcelona, 08035, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Ramon y Cajal /ID# 269318

Madrid, 28034, Spain

ACTIVE NOT RECRUITING

Hospital Universitario 12 de Octubre /ID# 269321

Madrid, 28041, Spain

ACTIVE NOT RECRUITING

Hospital Universitario La Paz /ID# 269302

Madrid, 28046, Spain

ACTIVE NOT RECRUITING

Hospital Universitario y Politecnico La Fe /ID# 269325

Valencia, 46026, Spain

COMPLETED

Related Links

• Related Info

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

mirvetuximab soravtansine; Lubricant Eye Drops; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

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: April 10, 2024
• First Posted: April 15, 2024
• Study Start: July 29, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8); US (12); IE (2); AU (3); CA (3); FR (6); BE (6)