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Recurrent Ovarian CancerPhase 2NCT06365853

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

A Phase 2 study testing Mirvetuximab Soravtansine, Lubricating Eye Drops and Prednisolone acetate ophthalmic suspension 1% eye drops in people with Recurrent Ovarian Cancer and Folate Receptor-Alpha Positive, run by AbbVie at 41 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Mirvetuximab Soravtansine, Lubricating Eye Drops and Prednisolone acetate ophthalmic suspension 1% eye drops
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
41 sitesin 7 countries
Study dates
29 Jul 2024to Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • Participants who received prior treatment with MIRV or other FRα-targeting agents. Note: Other protocol-defined inclusion and exclusion criteria may apply.

Trial locations and contacts

41 sites in 7 countries.

41 sites in 7 countries

United States13 sites

  • Summa Health /ID# 269349

    Akron, Ohio, 44304-1407

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

    Albany, New York, 12206-5013

  • Women'S Cancer Care Associates /ID# 269980

    Albany, New York, 12208

  • University of Texas - Southwestern Medical Center /ID# 269341

    Dallas, Texas, 75235

  • Duke Cancer Institute /ID# 269342

    Durham, North Carolina, 27710

  • Memorial Hermann Southeast Hospital /ID# 269347

    Houston, Texas, 77089

  • University of California Los Angeles /ID# 269339

    Los Angeles, California, 90095

  • Norton Cancer Institute - St. Matthews /ID# 269070

    Louisville, Kentucky, 40207

  • The Center Of Hope /ID# 269348

    Reno, Nevada, 89511

  • UCSF Medical Center /ID# 280425

    San Francisco, California, 94158-2531

  • Holy Cross Hospital - Silver Spring /ID# 269344

    Silver Spring, Maryland, 20910

  • Mercy David C. Pratt Cancer Center /ID# 269350

    St Louis, Missouri, 63141

  • Holy Name Medical Center /ID# 269340

    Teaneck, New Jersey, 07666

Other trials in United States

Spain8 sites

  • Usp Instituto Universitario Dexeus /ID# 269322

    Barcelona, 08028

  • Hospital Universitario Vall de Hebron /ID# 269315

    Barcelona, 08035

  • Hospital San Pedro de Alcantara /ID# 269320

    Cáceres, 10003

  • Hospital Universitario de Jaen /ID# 269319

    Jaén, 23007

  • Hospital Universitario Ramon y Cajal /ID# 269318

    Madrid, 28034

  • Hospital Universitario 12 de Octubre /ID# 269321

    Madrid, 28041

  • Hospital Universitario La Paz /ID# 269302

    Madrid, 28046

  • Hospital Universitario y Politecnico La Fe /ID# 269325

    Valencia, 46026

Other trials in Spain

Belgium6 sites

  • OLV Ziekenhuis Aalst /ID# 269311

    Aalst, Oost-Vlaanderen, 9300

  • Universitair Ziekenhuis Antwerpen /ID# 269310

    Edegem, Antwerpen, 2650

  • AZ Sint-Lucas /ID# 269307

    Ghent, Oost-Vlaanderen, 9000

  • UZ Gent /ID# 269309

    Ghent, Oost-Vlaanderen, 9000

  • Universitair Ziekenhuis Leuven /ID# 269308

    Leuven, Vlaams-Brabant, 3000

  • CHU de Liege /ID# 269312

    Liège, 4000

Other trials in Belgium

France6 sites

  • Clinique Victor Hugo Le Mans /ID# 269985

    Le Mans, Sarthe, 72000

  • Institut Paoli-Calmettes /ID# 269648

    Marseille, Bouches-du-Rhone, 13273

  • Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 269330

    Paris, Paris, 75679

  • GH Diaconesses Croix Saint-Simon /ID# 269329

    Paris, 75020

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

    Pierre-Bénite, Rhone, 69310

  • Centre Hospitalier Regional Universitaire de Tours - Hopital Bretonneau /ID# 269301

    Tours, Indre-et-Loire, 37000

Other trials in France

Australia3 sites

  • Blacktown Hospital /ID# 269305

    Blacktown, New South Wales, 2148

  • Monash Health - Monash Medical Centre - Clayton /ID# 269304

    Clayton, Victoria, 3168

  • Newcastle Private Hosptial /ID# 269306

    Lambton Heights, New South Wales, 2305

Other trials in Australia

Canada3 sites

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

    Montreal, Quebec, H1T 2M4

  • Centre Hospitalier de l'Universite de Montreal /ID# 269314

    Montreal, Quebec, H2X 0C1

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

    Montreal, Quebec, H4A 3J1

Other trials in Canada

Ireland2 sites

  • Mater Misericordiae University Hospital /ID# 269334

    Dublin, D07 R2WY

  • Beaumont Hospital /ID# 268864

    Dublin, D09 XR63

Other trials in Ireland

About this study

Official title: A Randomized Phase 2 Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Patients With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression

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.

Read the detailed description

Participants will be randomized (1:1) to 1 of 2 ocular adverse event (AE) risk mitigation strategy arms (primary prophylactic steroid eye drops versus primary prophylactic vasoconstricting eye drops).

Being tested
Mirvetuximab Soravtansine, Lubricating Eye Drops, Prednisolone acetate ophthalmic suspension 1% eye drops, Brimonidine tartrate ophthalmic solution eye drops
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mirvetuximab SoravtansineDrug

    Also called IMGN853, MIRV

    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.

  • Lubricating Eye DropsDrug

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

  • Prednisolone acetate ophthalmic suspension 1% eye dropsDrug

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

  • Brimonidine tartrate ophthalmic solution eye dropsDrug

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

Study groups in NCT06365853
Study groupRoleWhat they receive
Primary Prophylactic Steroid Eye DropsExperimentalPrednisolone 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.
Receives: Drug: Mirvetuximab Soravtansine; Drug: Lubricating Eye Drops; Drug: Prednisolone acetate ophthalmic suspension 1% eye drops
Primary Prophylactic Vasoconstricting Eye DropsExperimentalPrimary 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.
Receives: Drug: Mirvetuximab Soravtansine; Drug: Lubricating Eye Drops; Drug: Brimonidine tartrate ophthalmic solution eye drops

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 .

    Measured: 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)

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

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

  2. Number of Participants With MIRV-related Corneal TEAEs in Symptomatic Participants

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

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

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

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

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

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

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

  6. National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Composite Score

    Measured: At Cycle 5 Day 1 or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

  7. Area Under the Curve (AUC) of MIRV

    Measured: Day 1 and Day 8 of Cycles 1 through 4 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

  8. Maximum Serum Concentration (Cmax) of MIRV

    Measured: Day 1 and Day 8 of Cycles 1 through 4 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

  9. Trough Concentration (Ctrough) of MIRV

    Measured: Day 1 and Day 8 of Cycles 1 through 4 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2024
  2. Study start29 Jul 2024
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06365853
Sponsor's protocol ID
IMGN853-0424
Other IDs
2023-505617-24-00, 2023
Status last verified
Aug 2026
First submitted
10 Apr 2024
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mirvetuximab Soravtansine, Lubricating Eye Drops and Prednisolone acetate ophthalmic suspension 1% eye drops in people with Recurrent Ovarian Cancer and Folate Receptor-Alpha Positive, run by AbbVie at 41 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, Spain, Belgium, France, Australia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With MIRV-related Corneal TEAEs (≥ Grade 2) in Asymptomatic Participants (time frame: Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06365853.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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