Ovarian Cancer Clinical Trial

IMGN853 With Carboplatin in Second-line Treatment of FRα Expressing, Platinum-sensitive Epithelial Ovarian Cancer

Summary

IMGN853-0420 is a multicenter, open-label, phase 2 study of carboplatin plus mirvetuximab soravtansine followed by mirvetuximab soravtansine continuation in folate receptor-alpha positive, recurrent platinum sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer following 1 prior line of platinum-based chemotherapy.

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Full Description

This Phase 2 study is designed to evaluate the efficacy and safety of MIRV in combination with carboplatin followed by MIRV continuation in FRα-positive patients with recurrent platinum-sensitive ovarian cancer (PSOC) following 1 prior line of platinum-based chemotherapy. Upon completion of carboplatin plus MIRV combination chemotherapy (6 cycles), patients without progressive disease will continue on single-agent MIRV. Patients must have confirmation of FRα positivity by the Ventana FOLR1 Assay.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients must be ≥ 18 years of age.
Patients must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
Patients must have a confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.
Patients must have relapsed after 1 prior line of platinum-based chemotherapy.

Patients must have platinum-sensitive disease defined as radiographic progression greater than 6 months from last dose of platinum-based chemotherapy.

Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression.

Prior BRCA testing on the tumor or prior germline testing is required for eligibility. If not done prior, tumor or germline testing will need to be done at study entry. Somatic and germline BRCA-positive patients must have received prior treatment with a PARPi.
Patients must have at least 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the investigator).
Patients must provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα positivity; FRα-expressing tumors will be defined and classified by the Ventana FOLR1 Assay into low, medium, and high expressions defined as 25%-49%, 50%-74%, and ≥ 75% of tumor cells with PS2+ staining intensity, respectively. Patients must have confirmation of FRα positivity of ≥ 25% of tumor staining at ≥ 2+ intensity for entry into the study.
Patients must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia) and have discontinued any maintenance therapy at least 4 weeks before the first dose of carboplatin plus MIRV.
Patients must have completed any major surgery at least 4 weeks before the first dose of carboplatin plus MIRV and have recovered or stabilized from the side effects of prior surgery before the first dose of carboplatin plus MIRV.

Patients must have adequate hematologic, liver, and kidney functions defined as:

Absolute neutrophil count ≥ 1.5 × 109/L (1500/μL) without granulocyte colony-stimulating factor or long-acting white blood cell growth factors in the 10 days prior to the C1D1 dose
Platelet count ≥ 100 × 109/L (100,000/μL) without platelet transfusion in the 10 days prior to the C1D1 dose
Hemoglobin ≥ 9.0 g/dL without packed red blood cell transfusion in the 14 days prior to the C1D1 dose
Serum creatinine ≤ 1.5 × ULN
Aspartate aminotransferase and alanine aminotransferase ≤ 3.0 × ULN
Serum bilirubin ≤ 1.5 × ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 × ULN)
Serum albumin ≥ 2 g/dL
Patients must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements.
Females of childbearing potential (FCBP) must agree to use highly effective contraceptive method(s) while on study medication and for at least 3 months after the last dose of MIRV and 6 months after the last dose of carboplatin.
FCBP must have a negative pregnancy test within the 4 days prior to the C1D1 dose.

Exclusion Criteria:

Patients with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above types, or low-grade/borderline ovarian tumor

More than one line of prior chemotherapy. Lines of prior anticancer therapy are counted with the following considerations:

Neoadjuvant ± adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens.
Maintenance therapy (eg, bevacizumab, PARPi) will be considered part of the preceding line of therapy (ie, not counted independently).
Patients with prior wide-field radiotherapy affecting at least 20% of the bone marrow
Patients with > Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE)
Patients with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, or monocular vision

Patients with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:

Active hepatitis B or C infection (whether or not on active antiviral therapy)
HIV infection
Active cytomegalovirus infection
Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of carboplatin plus MIRV Note: Testing at screening is not required for the above infections unless clinically indicated.
Patients with a history of multiple sclerosis or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)

Patients with clinically significant cardiac disease including, but not limited to, any of the following:

Myocardial infarction ≤ 6 months prior to first dose
Unstable angina pectoris
Uncontrolled congestive heart failure (New York Heart Association > class II)
Uncontrolled ≥ Grade 3 hypertension (per CTCAE)
Uncontrolled cardiac arrhythmias
Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment
Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)
Patients with a previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis (exception: Grade 1 noninfectious pneumonitis diagnosed on or within 6 weeks after treatment with an immunotherapeutic agent used in the treatment of their malignancy that has resolved per investigator or resolution of the radiologic findings)
Patients requiring use of folate-containing supplements (eg, folate deficiency)
Patients with prior hypersensitivity to monoclonal antibodies (mAb)
Females who are pregnant or breastfeeding
Patients who received prior treatment with MIRV or other FRα-targeting agents
Patients with untreated or symptomatic central nervous system metastases
Patients with a history of other malignancy within 3 years before enrollment Note: patients with tumors with a negligible risk for metastasis or death (eg, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible.
Prior known hypersensitivity reactions to study drugs or any of their excipients

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

114

Study ID:

NCT05456685

Recruitment Status:

Recruiting

Sponsor:

ImmunoGen, Inc.

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There are 72 Locations for this study

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University of Arizona Cancer Center
Tucson Arizona, 85719, United States More Info
Setsuko Chambers
Contact
520-626-0950
[email protected]
Setsuko Chambers, MD
Principal Investigator
Women's Cancer Research Network
Fresno California, 93710, United States
Providence Medical Foundation
Fullerton California, 92835, United States More Info
Monica Lee
Contact
714-446-5900
[email protected]
Monica Lee, MD
Principal Investigator
Scripps MD Anderson Cancer Center
La Jolla California, 92037, United States More Info
Wesleigh Edwards
Contact
[email protected]
Wesleigh Edwards
Principal Investigator
University of California San Diego (UCSD) - Moores Cancer Center
La Jolla California, 92093, United States More Info
Ramez Eskander
Contact
858-822-0201
[email protected]
Ramez Eskander
Principal Investigator
University of Southern California
Los Angeles California, 90033, United States More Info
Koji Matsuo
Contact
323-865-0463
[email protected]
Koji Matsuo
Principal Investigator
University of California
Los Angeles California, 90095, United States More Info
Gottfried Konecny, MD
Contact
310-794-4955
[email protected]
Gottfried Konecny
Principal Investigator
Hoag Hospital
Newport Beach California, 92663, United States More Info
Alberto Mendivil
Contact
[email protected]
Alberto Mendivil
Principal Investigator
UC Davis Comprehensive Cancer Center
Sacramento California, 95817, United States More Info
Nancy Nguyen
Contact
[email protected]
Nancy Nguyen
Principal Investigator
California Pacific Medical Center
San Francisco California, 94109, United States More Info
John Chan
Contact
415-600-0930
[email protected]
John Chan
Principal Investigator
Smilow Cancer Hospital
New Haven Connecticut, 06519, United States More Info
Alessandro Santin
Contact
Alessandro Santin
Principal Investigator
AdventHealth Orlando - Cancer Institute
Orlando Florida, 32804, United States More Info
Robert Holloway
Contact
407-303-2422
[email protected]
Robert Holloway
Principal Investigator
Sarasota Memorial Health Care System
Sarasota Florida, 34239, United States More Info
Beverly Long
Contact
941-917-2225
[email protected]
Beverly Long
Principal Investigator
H Lee Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Hye Sook Chon
Contact
[email protected]
Hye Sook Chon
Principal Investigator
Emory University
Atlanta Georgia, 30322, United States More Info
Susan Modesitt
Contact
404-778-1900
[email protected]
Susan Modesitt
Principal Investigator
Northwestern Memorial Hospital
Chicago Illinois, 60611, United States More Info
Dario Roque, MD
Contact
312-695-0990
[email protected]
Dario Roque
Principal Investigator
Northwestern University - Kishwaukee Cancer Center
DeKalb Illinois, 60115, United States More Info
Dario Roque
Contact
[email protected]
Dario Roque, MD
Principal Investigator
Northwestern University - Delnor Cancer Center
Geneva Illinois, 60134, United States More Info
Dario Roque
Contact
[email protected]
Dario Roque, MD
Principal Investigator
Northwestern University - Warrenville Cancer Center
Warrenville Illinois, 60555, United States More Info
Dario Roque
Contact
[email protected]
Dario Roque, MD
Principal Investigator
Women's Cancer Care
Covington Louisiana, 70433, United States More Info
Patricia Braly, MD
Contact
985-892-2252
[email protected]
Patricia Braly
Principal Investigator
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Sara Bouberhan
Contact
413-209-4240
[email protected]
Sara Bouberhan, MD
Principal Investigator
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Ursula Matulonis
Contact
617-632-2334
[email protected]
Ursula Matulonis, MD
Principal Investigator
Karmanos Cancer Institute
Detroit Michigan, 48201, United States More Info
Ira Winer, MD
Contact
313-576-9435
[email protected]
Ira Winer
Principal Investigator
Washington University School of Medicine
Saint Louis Missouri, 63108, United States More Info
Premal Thaker
Contact
314-747-3604
[email protected]
Premal Thaker
Principal Investigator
Center of Hope
Reno Nevada, 89511, United States More Info
Peter Lim, MD
Contact
775-327-4673
[email protected]
Peter Lim
Principal Investigator
MD Anderson Cancer Center at Cooper
Camden New Jersey, 08103, United States More Info
David Warshal
Contact
856-735-6209
[email protected]
David Warshal
Principal Investigator
Holy Name Medical Center
Teaneck New Jersey, 07666, United States More Info
Sharyn Lewin
Contact
201-227-6200
[email protected]
Sharyn Lewin
Principal Investigator
New Mexico Cancer Care Alliance / University of New Mexico CCC
Albuquerque New Mexico, 87102, United States More Info
Colleen McCormick, MD
Contact
505-272-7813
[email protected]
Colleen McCormick, MD
Principal Investigator
Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho New Mexico, 87124, United States More Info
Colleen McCormick
Contact
[email protected]
Colleen McCormick
Principal Investigator
Columbia University Medical Center
New York New York, 10032, United States More Info
Jason Wright
Contact
212-305-3410
[email protected]
Jason Wright
Principal Investigator
Northwell Health
Whitestone New York, 11357, United States More Info
Marina Frimer
Contact
347-804-8291
[email protected]
Marina Frimer
Principal Investigator
University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27599, United States More Info
Linda Van Le
Contact
919-360-2702
[email protected]
Linda Van Le
Principal Investigator
Duke Cancer Center
Durham North Carolina, 27710, United States More Info
Angeles Secord
Contact
919-684-3765
[email protected]
Angeles Secord
Principal Investigator
OU Health Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States More Info
Lauren Dockery, MD, MS
Contact
405-271-7770
[email protected]
Lauren Dockery
Principal Investigator
Women & Infants Hospital of Rhode Island
Providence Rhode Island, 02905, United States More Info
Cara Mathews
Contact
401-453-7520
[email protected]
Cara Mathews
Principal Investigator
Medical University of South Carolina - Hollings Cancer Center
Charleston South Carolina, 29425, United States More Info
Whitney Graybill
Contact
[email protected]
Whitney Graybill
Principal Investigator
UT Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Jayanth Lea
Contact
214-648-2214
[email protected]
Jayanth Lea
Principal Investigator
Kadlec Clinic Hematology/Oncology
Kennewick Washington, 99336, United States More Info
Ying Zhou
Contact
509-942-2540
[email protected]
Ying Zhou
Principal Investigator
Cliniques Universitaires Saint-Luc
Bruxelles , 1200, Belgium More Info
Jean-Francois Baurain
Contact
+32 276445471
[email protected]
Jean-Francois Baurain
Principal Investigator
UZLeuven
Leuven , 3000, Belgium More Info
Toon Van Gorp
Contact
[email protected]
Toon Van Gorp
Principal Investigator
CHU de Liege
Liège , 4000, Belgium More Info
Christine Gennigens
Contact
+32 43667664
[email protected]
Christine Gennigens
Principal Investigator
BC Cancer Vancouver
Vancouver British Columbia, V5Z 4, Canada More Info
Anna Tinker
Contact
604-877-6000
[email protected]
Anna Tinker
Principal Investigator
CIUSSS de l'IIe-de-Montreal
Montréal Quebec, H1T 2, Canada More Info
Suzanne Fortin
Contact
514-252-3400
[email protected]
Suzanne Fortin
Principal Investigator
Centre Hospitalier de l'Université de Montréal
Montréal Quebec, H2X 3, Canada More Info
Diane Provencher
Contact
514-890-8444
[email protected]
Diane Provencher
Principal Investigator
McGill University Health Centre
Montréal Quebec, H4A 3, Canada More Info
Lucy Gilbert
Contact
514 934 1934
[email protected]
Lucy Gilbert
Principal Investigator
Ciussse-Chus
Sherbrooke Quebec, J1H 5, Canada More Info
Paul Bessette
Contact
819-346-1110
[email protected]
Paul Bessette
Principal Investigator
LTD "High Technology Hospital Medcenter"
Batumi , 6000, Georgia More Info
Tamta Makharadze
Contact
+995 568 999 559
[email protected]
Tamta Makharadze
Principal Investigator
LLC American Hospital Network
Tbilisi , 0102, Georgia More Info
Zaza Tsitsishvili
Contact
+995 599218300
[email protected]
Zaza Tsitsishvili
Principal Investigator
Israel Georgian Medical Research Clinic Healthycore
Tbilisi , 0112, Georgia More Info
Ekaterine Arkania
Contact
+995 599 92 20 81
[email protected]
Ekaterine Arkania
Principal Investigator
JSC Vian - Caraps Medline
Tbilisi , 0159, Georgia More Info
Nana Chikhladze
Contact
[email protected]
Nana Chikhladze
Principal Investigator
Ltd - Consilium Medulla
Tbilisi , 0160, Georgia More Info
Lia Abshilava
Contact
[email protected]
Lia Abshilava
Principal Investigator
Hospital Teresa Herrera-Chuac
A Coruña , 15006, Spain More Info
Maria Quindos Varela
Contact
[email protected]
Maria Quindos Varela
Principal Investigator
Hospital Universitario De Badajoz
Badajoz , 06006, Spain More Info
Alba González-Haba
Contact
+34 924218040
[email protected]
Alba González-Haba
Principal Investigator
Hospital Dexeus
Barcelona , 08028, Spain More Info
Alejandro Martinez Bueno
Contact
+34 935460135
[email protected]
Alejandro Martinez Bueno
Principal Investigator
Vall d'Hebron Institute of Oncology
Barcelona , 08035, Spain More Info
Ana Oaknin
Principal Investigator
Catalan Institute of Oncology ICO
Barcelona , 08916, Spain More Info
Margarita Romeo Marin
Contact
+34 934978925
[email protected]
Margarita Romeo Marin
Principal Investigator
Hospital Universitario Reina Sofia
Córdoba , 14004, Spain More Info
María Jesus Rubio Perez
Contact
34 957011464
[email protected]
María Jesus Rubio Perez
Principal Investigator
H. U Arnau de Vilanova de Lleida
Lleida , 25198, Spain More Info
Eleonor Paola Murata
Contact
34973705362
[email protected]
Eleonor Paola Murata
Principal Investigator
Clinica Universidad de Navarra
Madrid , 28027, Spain More Info
Antonio Gonzalez
Contact
91.353.19.20
[email protected]
Antonio Gonzalez
Principal Investigator
START Madrid Fundación Jiménez Díaz
Madrid , 28040, Spain More Info
Bernard Doger
Contact
34 91 550 48 00
[email protected]
Bernard Doger
Principal Investigator
12 de Octubre University Hospital
Madrid , 28041, Spain More Info
Ainhoa Madariaga
Contact
34 91 390 86 26
[email protected]
Ainhoa Madariaga
Principal Investigator
Hm Sanchinarro Ciocc
Madrid , 28050, Spain More Info
Arantzazu Barquin Garcia
Contact
+34 917567800
[email protected]
Arantzazu Barquin Garcia
Principal Investigator
Clinica Universidad de Navarra - Pamplona
Pamplona , 31008, Spain More Info
Antonio Gonzalez
Contact
[email protected]
Antonio Gonzalez
Principal Investigator
Hospital Clinico de Valencia
Valencia , 46010, Spain More Info
Jose Alejandro Perez Fidalgo
Contact
+34 645317947
[email protected]
Jose Alejandro Perez Fidalgo
Principal Investigator
The Royal Marsden NHS Foundation Trust
Sutton Surrey, SM2 5, United Kingdom More Info
Susana Banerjee
Contact
[email protected]
Susana Banerjee
Principal Investigator
Guy's Hospital
London , SE1 9, United Kingdom More Info
Rebecca Kristeleit
Contact
020 7188 1474
[email protected]
Rebecca Kristeleit
Principal Investigator
The Royal Marsden NHS Foundation Trust
London , SW3 6, United Kingdom More Info
Susana Banerjee
Contact
[email protected]
Susana Banerjee
Principal Investigator
Hammersmith Hospital
London , W12 0, United Kingdom More Info
Jonathan Krell
Contact
[email protected]
Jonathan Krell
Principal Investigator
The Christie NUS Foundation Trust
Manchester , M20 4, United Kingdom More Info
Jurjees Hasan
Contact
0161 446 3740
[email protected]
Jurjees Hasan
Principal Investigator
Mount Vernon Cancer Centre
Northwood , HA6 2, United Kingdom More Info
Saira Khalique
Contact
[email protected]
Saira Khalique
Principal Investigator
Nottingham University Hospitals NHS Trust
Nottingham , NG5 1, United Kingdom More Info
Anjana Anand
Contact
0115 969116
[email protected]
Anjana Anand
Principal Investigator
Musgrove Park Hospital
Taunton , TA15D, United Kingdom More Info
Clare Barlow
Contact
[email protected]
Clare Barlow
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

114

Study ID:

NCT05456685

Recruitment Status:

Recruiting

Sponsor:


ImmunoGen, Inc.

How clear is this clinincal trial information?

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