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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505617-24-00 | Other Identifier | EU CT |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles /ID# 269339 | Recruiting | Los Angeles | California | 90095 | United States | |
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| Lubricating Eye Drops | Drug | Lubricating artificial tears should be administered at least 15 minutes after corticosteroid or brimonidine eye drop administration. |
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| Prednisolone acetate ophthalmic suspension 1% eye drops | Drug | Self-administration of prednisolone acetate ophthalmic suspension 1% eye drops as prescribed by the treating physician. |
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| Brimonidine tartrate ophthalmic solution eye drops | Drug | Self-administration of brimonidine tartrate ophthalmic solution eye drops as prescribed by the treating physician. |
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| 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) |
| National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Composite Score | At Cycle 5 Day 1 or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days) |
| Area Under the Curve (AUC) of MIRV | 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) |
| Maximum Serum Concentration (Cmax) of MIRV | 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) |
| Trough Concentration (Ctrough) of MIRV | 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) |
| Norton Cancer Institute - St. Matthews /ID# 269070 |
| Completed |
| Louisville |
| Kentucky |
| 40207 |
| United States |
| Holy Cross Hospital - Silver Spring /ID# 269344 | Recruiting | Silver Spring | Maryland | 20910 | United States |
| Mercy David C. Pratt Cancer Center /ID# 269350 | Recruiting | St Louis | Missouri | 63141 | United States |
| The Center Of Hope /ID# 269348 | Active, not recruiting | Reno | Nevada | 89511 | United States |
| Holy Name Medical Center /ID# 269340 | Recruiting | Teaneck | New Jersey | 07666 | United States |
| New York Oncology Hematology - Albany Cancer Center /ID# 269345 | Completed | Albany | New York | 12206-5013 | United States |
| Women'S Cancer Care Associates /ID# 269980 | Completed | Albany | New York | 12208 | United States |
| Duke Cancer Institute /ID# 269342 | Recruiting | Durham | North Carolina | 27710 | United States |
| Summa Health /ID# 269349 | Recruiting | Akron | Ohio | 44304-1407 | United States |
| UT Southwestern Medical Center /ID# 269341 | Recruiting | Dallas | Texas | 75390 | United States |
| Memorial Hermann Southeast Hospital /ID# 269347 | Completed | Houston | Texas | 77089 | United States |
| Blacktown Hospital /ID# 269305 | Active, not recruiting | Blacktown | New South Wales | 2148 | Australia |
| Newcastle Private Hosptial /ID# 269306 | Active, not recruiting | Lambton Heights | New South Wales | 2305 | Australia |
| Monash Health - Monash Medical Centre - Clayton /ID# 269304 | Active, not recruiting | Clayton | Victoria | 3168 | Australia |
| Universitair Ziekenhuis Antwerpen /ID# 269310 | Completed | Edegem | Antwerpen | 2650 | Belgium |
| OLV Ziekenhuis Aalst /ID# 269311 | Active, not recruiting | Aalst | Oost-Vlaanderen | 9300 | Belgium |
| AZ Sint-Lucas /ID# 269307 | Active, not recruiting | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| UZ Gent /ID# 269309 | Completed | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| Universitair Ziekenhuis Leuven /ID# 269308 | Active, not recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
| CHU de Liege /ID# 269312 | Completed | Liège | 4000 | Belgium |
| Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 268862 | Active, not recruiting | Montreal | Quebec | H1T 2M4 | Canada |
| Hospital Notre-Dame Du Centre Hospitalier De L'Universite De Montreal /ID# 269314 | Active, not recruiting | Montreal | Quebec | H2L 4M1 | Canada |
| McGill University Health Centre - Glen Site. /ID# 269313 | Active, not recruiting | Montreal | Quebec | H4A 3J1 | Canada |
| Institut Paoli-Calmettes /ID# 269648 | Active, not recruiting | Marseille | Bouches-du-Rhone | 13273 | France |
| Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 269301 | Active, not recruiting | Tours | Indre-et-Loire | 37000 | France |
| Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 269330 | Active, not recruiting | Paris | Paris | 75679 | France |
| Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud /ID# 269327 | Active, not recruiting | Pierre-Bénite | Rhone | 69310 | France |
| Clinique Victor Hugo Le Mans /ID# 269985 | Active, not recruiting | Le Mans | Sarthe | 72000 | France |
| GH Diaconesses Croix Saint-Simon /ID# 269329 | Active, not recruiting | Paris | 75020 | France |
| Mater Misericordiae University Hospital /ID# 269334 | Active, not recruiting | Dublin | D07 R2WY | Ireland |
| Beaumont Hospital /ID# 268864 | Completed | Dublin | D09 XR63 | Ireland |
| Hospital San Pedro de Alcántara /ID# 269320 | Active, not recruiting | Cáceres | Caceres | 10003 | Spain |
| Hospital Universitario de Jaén /ID# 269319 | Active, not recruiting | Jaén | Jaen | 23007 | Spain |
| Usp Instituto Universitario Dexeus /ID# 269322 | Active, not recruiting | Barcelona | 08028 | Spain |
| Hospital Universitario Vall de Hebron /ID# 269315 | Active, not recruiting | Barcelona | 08035 | Spain |
| Hospital Universitario Ramon y Cajal /ID# 269318 | Active, not recruiting | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre /ID# 269321 | Active, not recruiting | Madrid | 28041 | Spain |
| Hospital Universitario La Paz /ID# 269302 | Active, not recruiting | Madrid | 28046 | Spain |
| Hospital Universitario y Politecnico La Fe /ID# 269325 | Completed | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C000607289 | mirvetuximab soravtansine |
| D065346 | Lubricant Eye Drops |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |
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