A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.

Purpose

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 neoadjuvant carboplatin and mirvetuximab soravtansine in participants with folate receptor alpha (FRα) -expressing advanced-stage serous epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC). 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). This is a single arm study in adult participants with advanced-stage Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) III-IV FRα-expressing serous EOC. Around 140 participants will be enrolled in the study at approximately 80 sites in the United States. Participants will receive intravenous infusion of MIRV in combination with carboplatin on day 1 of each cycle, every 21 days for up to 6 - 9 Cycles. The total study duration will be approximately 3 years . 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

  • Epithelial Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
  • Neoadjuvant

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Be judged by the investigator and/or treating physician to be an appropriate candidate to receive neoadjuvant chemotherapy. - Diagnosis of biopsy-confirmed high-grade, serous epithelial ovarian, fallopian tube or primary peritoneal cancer. - Participant meets the following disease criteria: - Stage III or IV disease by the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) staging system, 27 and - Folate Receptor Alpha (FRα) expression positivity as defined by immunohistochemical staining of >= 75% of viable tumor cells with moderate (2+) and/or strong (3+) membrane staining by the AbbVie specified vendor with the Ventana Folate Receptor Alpha (FOLR1) assay, and - Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria.

Exclusion Criteria

  • Endometrioid, clear cell, mucinous, or sarcomatous tumor histology; mixed tumors containing any of the above histologies; or low-grade/borderline ovarian tumor. - Previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis. - Previously treated with anticancer therapy including chemotherapy, radiation therapy, immunotherapy, or biologic agent for current cancer, with the exception of one cycle of single agent carboplatin - Participants with the following ocular history and/or concurrent disorders: - History of corneal transplantation; - Undergoing active postoperative management for refractive surgery, cataract surgery, corneal cross-linking, or corneal complications of surgery; - Confluent superficial punctate keratopathy (SPK) not expected to resolve to non-confluence or better within the screening window with standard of care (SOC) intervention; - Active or chronic clinically significant (>= Grade 3) corneal dystrophy (e.g., Fuchs dystrophy); - Active ocular conditions requiring ongoing treatment/monitoring, such as glaucoma, which is not adequately controlled with medication or surgery, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema or an ocular condition with high risk of retinal detachment; - Monocular vision with visual acuity in the worse eye, worse than 20/200 or visual fields less than 20 degrees (i.e., functional blindness in at least one eye). - History of other malignancy within 3 years prior to signing study consent. -- Note: Participants with tumors with a negligible risk for metastasis or death (e.g., adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Carboplatin + Mirvetuximab Soravtansine 		Participants will receive carboplatin in combination with mirvetuximab soravtansine on Day 1 of a 21-day cycle per dose +/- Bevacizumab per investigator's discretion.
  • Drug: Carboplatin
    Intravenous (IV) infusion
  • Drug: Mirvetuximab Soravtansine
    Intravenous (IV) infusion
    Other names:
    • MIRV
    • IMGN853
    • ELAHERE™
  • Drug: Bevacizumab
    Intravenous (IV) infusion (per investigator's discretion)

Recruiting Locations

University of Alabama at Birmingham (UAB) Hospital /ID# 274793
Birmingham 4049979, Alabama 4829764 35294

California Pacific Medical Center /ID# 275329
San Francisco 5391959, California 5332921 94109

Ridley Tree Cancer Center /ID# 275219
Santa Barbara 5392952, California 5332921 93105

Danbury Hospital, Western Connecticut Health Network /ID# 274783
Danbury 4832353, Connecticut 4831725 06810

Norwalk Hospital /ID# 274561
Norwalk 4839822, Connecticut 4831725 06856

Jupiter Medical Center /ID# 276616
Jupiter 4160610, Florida 4155751 33458

Mount Sinai Medical Center /ID# 274868
Miami 4164138, Florida 4155751 33140

OSF St. Francis Medical Center /ID# 274752
Peoria 4905687, Illinois 4896861 61637-0001

Women'S Cancer Care /ID# 276469
Covington 4321005, Louisiana 4331987 70433

University Medical Center New Orleans /ID# 274755
New Orleans 4335045, Louisiana 4331987 70112

Trials 365 /ID# 274310
Shreveport 4341513, Louisiana 4331987 71103

Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 274780
Saint Louis Park 5045021, Minnesota 5037779 55416

Cox Medical Center South /ID# 274826
Springfield 4409896, Missouri 4398678 65807

The Center Of Hope /ID# 274313
Reno 5511077, Nevada 5509151 89511

Rutgers Cancer Institute of New Jersey /ID# 274358
New Brunswick 5101717, New Jersey 5101760 08901

Imbert Cancer Center /ID# 275634
Bay Shore 5108169, New York 5128638 11706

Northwell Health Cancer Institute At Huntington /ID# 276814
Greenlawn 5119377, New York 5128638 11740

Northwell Health Center for Advanced Medicine. /ID# 275641
Lake Success 5123853, New York 5128638 11042

Northwell Health Queens Cancer Center /ID# 274850
Rego Park 5133640, New York 5128638 11374

The Mark H Zangmeister Center /ID# 275106
Columbus 4509177, Ohio 5165418 43219

Oncology Associates of Oregon, P.C. /ID# 275006
Eugene 5725846, Oregon 5744337 97401

Northwest Cancer Specialists /ID# 275101
Portland 5746545, Oregon 5744337 97227-1800
Contact:
Site Coordinator
(971) 708-7600

St. Lukes University Hospital /ID# 274362
Bethlehem 5180225, Pennsylvania 6254927 18015

University of Pennsylvania /ID# 275612
Philadelphia 4560349, Pennsylvania 6254927 19104

Women & Infants Hospital /ID# 274716
Providence 5224151, Rhode Island 5224323 02905

Texas Oncology - Austin Central /ID# 275046
Austin 4671654, Texas 4736286 78731

Texas Oncology - San Antonio Medical Center - Research Drive /ID# 275090
San Antonio 4726206, Texas 4736286 78240

Texas Oncology - The Woodlands /ID# 275015
The Woodlands 4736476, Texas 4736286 77380

Texas Oncology - Northeast Texas /ID# 275057
Tyler 4738214, Texas 4736286 75702

UVA Health University Hospital /ID# 275309
Charlottesville 4752031, Virginia 6254928 22903

Carilion Clinic /ID# 274684
Roanoke 4782167, Virginia 6254928 24013

Providence Sacred Heart Medical Center & Children'S Hospital /ID# 274585
Spokane 5811696, Washington 5815135 99204

West Virginia University School of Medicine /ID# 274556
Morgantown 4815352, West Virginia 4826850 26506

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com