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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06365853




Registration number
NCT06365853
Ethics application status
Date submitted
10/04/2024
Date registered
15/04/2024
Date last updated
15/04/2024

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2023-505617-24-00
Secondary ID [2] 0 0
IMGN853-0424
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent Ovarian Cancer 0 0
Folate Receptor-Alpha Positive 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Eye 0 0 0 0
Diseases / disorders of the eye
Neurological 0 0 0 0
Other neurological disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mirvetuximab Soravtansine
Treatment: Drugs - Lubricating Eye Drops
Treatment: Drugs - Prednisolone acetate ophthalmic suspension 1% eye drops
Treatment: Drugs - Brimonidine tartrate ophthalmic solution eye drops

Experimental: Primary Prophylactic Steroid Eye Drops - 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). Each cycle length = 21 days.

Experimental: Primary Prophylactic Vasoconstricting Eye Drops - Primary prophylactic brimonidine tartrate ophthalmic solution eye drops 3 times daily (TID) throughout the cycle; 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. Each cycle length = 21 days.


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

Treatment: Drugs: Lubricating Eye Drops
Lubricating artificial tears should be administered at least 15 minutes after corticosteroid or brimonidine eye drop administration.

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

Treatment: Drugs: Brimonidine tartrate ophthalmic solution eye drops
Self-administration of brimonidine tartrate ophthalmic solution eye drops as prescribed by the treating physician.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With MIRV-related Corneal AEs (= Grade 2) in Asymptomatic Participants
Timepoint [1] 0 0
Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Secondary outcome [1] 0 0
Number of Participants With All Ocular TEAEs in Participants Using Corticosteroid Versus Vasoconstricting Eye Drop Primary Prophylaxis
Timepoint [1] 0 0
Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Secondary outcome [2] 0 0
Number of Participants With MIRV-related Corneal AEs and All Ocular TEAEs in Asymptomatic Versus Symptomatic Participants
Timepoint [2] 0 0
Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Secondary outcome [3] 0 0
Number of Participants With MIRV-related Corneal AEs and All Ocular TEAEs in Participants Using Corticosteroid Versus Vasoconstricting Eye Drop Primary Prophylaxis
Timepoint [3] 0 0
Cycle 1 Day 1 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Secondary outcome [4] 0 0
National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Composite Score
Timepoint [4] 0 0
At Cycle 5 Day 1 or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)
Secondary outcome [5] 0 0
Area Under the Curve (AUC) of MIRV
Timepoint [5] 0 0
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)
Secondary outcome [6] 0 0
Maximum Serum Concentration (Cmax) of MIRV
Timepoint [6] 0 0
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)
Secondary outcome [7] 0 0
Trough Concentration (Ctrough) of MIRV
Timepoint [7] 0 0
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)

Eligibility
Key inclusion criteria
Key

- Participants must have a confirmed diagnosis of epithelial ovarian, fallopian tube,
and primary peritoneal cancer (EOC) with high FRa expression.

- Participant's tumor must be FRa positive (FRa high) as defined by either the Ventana
folate receptor 1 (FOLR1) (FOLR1-2.1) CDX Assay or Ventana FOLR1 (FOLR1-2.1) RxDx
Assay (hereafter collectively termed: Ventana FOLR1 Assay) (=75% cells exhibit 2 or 3+
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:

1. Systemic antineoplastic therapy = 5 half-lives or 4 weeks (whichever is shorter)
prior to first dose of MIRV;

2. Focal radiation completed = 2 weeks prior to 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 prior to the first dose of MIRV.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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 = 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 prior to first dose,
presence of papilledema, best corrected visual acuity (BCVA) worse than 20/70, 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 FRa-targeting agents.

Note: Other protocol-defined inclusion and exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/05/2027
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash University - Monash Medical Centre (MMC) - Clayton - Clayton
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Belgium
State/province [8] 0 0
Antwerp
Country [9] 0 0
Belgium
State/province [9] 0 0
East Flanders
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
France
State/province [11] 0 0
Paris
Country [12] 0 0
France
State/province [12] 0 0
Pierre Benite
Country [13] 0 0
Ireland
State/province [13] 0 0
Dublin
Country [14] 0 0
Italy
State/province [14] 0 0
Milan
Country [15] 0 0
Spain
State/province [15] 0 0
Barcelona
Country [16] 0 0
Spain
State/province [16] 0 0
Jaen

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ImmunoGen, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the incidence rate and severity of pre-specified
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 (FRa) expression.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06365853
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sheri Spunt, MD
Address 0 0
ImmunoGen, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ImmunoGen, Inc.
Address 0 0
Country 0 0
Phone 0 0
781-895-0600
Fax 0 0
Email 0 0
424medical@immunogen.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06365853