Ovarian Cancer Clinical Trial

Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian Tube Cancers (PICCOLO)

Summary

PICCOLO (IMGN853-0419) is a Phase 2 multicenter, open label study designed to evaluate the safety and efficacy of Mirvetuximab Soravtansine in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression.

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Full Description

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 the tumor cells carrying a tumor-associated protein called folate receptor alpha (FRα). It is being developed for the treatment of subjects with recurrent platinum-sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression. Patients will have had at least 2 prior lines of therapy. These will include at least 2 lines of platinum-containing therapy or 1 line with a documented platinum allergy. FRα positivity will be defined by the Ventana FOLR1 (FOLR1- 2.1) CDx assay (Ventana FOLR1 Assay)

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Patients ≥ 18 years of age
Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
Patients must have a confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer
Patients must have platinum-sensitive disease defined as radiographic progression greater than 6 months from last dose of most recent platinum therapy 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
Patients must have progressed radiographically on or after their most recent line of anticancer therapy
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 be willing to 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
Patient's tumor must be positive for FRα expression as defined by the Ventana FOLR1 Assay

Prior anticancer therapy

Patients must have received at least 2 prior systemic lines of platinum therapy and be considered by the Investigator as appropriate for single-agent non-platinum therapy (documentation required - eg, high risk of hypersensitivity reaction; risk of further cumulative toxicity with additional platinum, including but not limited to myelosuppression, neuropathy, renal insufficiency or other) i. Note: Patients who have had a documented platinum allergy may have had only 1 prior line of platinum
Patients may have received up to but no more than 1 prior independent non-platinum cytotoxic therapy
Patients must have had testing for breast cancer susceptibility gene (BRCA) mutation (tumor or germline) and, if positive, must have received a prior poly (ADP-ribose) polymerase ( (PARP) inhibitor as either treatment or maintenance therapy
Neoadjuvant ± adjuvant therapies are considered 1 line of therapy
Maintenance therapy (eg, bevacizumab, PARP inhibitors) will be considered part of the preceding line of therapy (ie, not counted independently)
Therapy changed due to toxicity in the absence of progression will be considered part of the same line (ie, not counted independently)

Patients must have completed prior therapy within the specified times below:

Systemic antineoplastic therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to first dose of MIRV
Focal radiation completed at least 2 weeks prior to first dose of MIRV
Patients must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia)
Patients must have completed any major surgery at least 4 weeks prior to first dose of MIRV and have recovered or stabilized from the side effects of prior surgery prior to first dose of MIRV

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

Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1500/μL) without granulocyte colony-stimulating factor (G-CSF) in the prior 10 days or long-acting white blood cell (WBC) growth factors in the prior 20 days
Platelet count ≥ 100 x 10^9/L (100,000/μL) without platelet transfusion in the prior 10 days
Hemoglobin ≥ 9.0 g/dL without packed red blood cell (PRBC) transfusion in the prior 21 days
Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN
Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 x 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
Women of childbearing potential (WCBP) must agree to use highly effective contraceptive method(s) while on MIRV and for at least 3 months after the last dose
WCBP must have a negative pregnancy test within the 4 days prior to the first dose of MIRV

Key Exclusion Criteria-

Patients with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumor
Patients with prior wide-field radiotherapy (RT) 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, and/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 MIRV

Note: Testing at screening is not required for the above infections unless clinically indicated.

Patients with a history of multiple sclerosis (MS) 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 (ILD), including noninfectious pneumonitis
Patients requiring use of folate-containing supplements (eg, folate deficiency)
Patients with prior hypersensitivity to monoclonal antibodies (mAb)
Women 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 (CNS) metastases

Patients with a history of other malignancy within 3 years prior to 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 and/or any of their excipients

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

75

Study ID:

NCT05041257

Recruitment Status:

Recruiting

Sponsor:

ImmunoGen, Inc.

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There are 74 Locations for this study

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The University of Alabama at Birmingham - Division of Gynecology Oncology O'Neal Comprehensive Cancer Center
Birmingham Alabama, 35233, United States More Info
Sara Robinson
Contact
205-975-7839
[email protected]
Charles Leath
Principal Investigator
Alaska Women's Cancer Care/Providence Alaska Medical Center
Anchorage Alaska, 99508, United States More Info
Christina Fulcher
Contact
907-212-4778
[email protected]
Melissa Hardesty
Principal Investigator
Arizona Oncology Associates, PC - HOPE
Tucson Arizona, 85711, United States More Info
Stacey M Kimbell
Contact
520-797-4468
[email protected]
Joseph Buscema
Principal Investigator
City of Hope
Duarte California, 91010, United States More Info
Lindsay Kilpatrick
Contact
626-218-9036
[email protected]
Daphne Stewart
Principal Investigator
UCLA-JCCC Dept of OBGYN - Women's Health Clinical Research Unit
Los Angeles California, 90095, United States More Info
Heather leatherwood
Contact
310-794-9652
[email protected]
Gottfried Konecny
Principal Investigator
University of Colorado School of Medicine
Aurora Colorado, 80045, United States More Info
Tyler Poon
Contact
303-720-5878
[email protected]
Bradley Corr
Principal Investigator
Yale University School of Medicine
New Haven Connecticut, 06520, United States More Info
Lisa Baker
Contact
203-785-6398
[email protected]
Alessandro Santin
Principal Investigator
Florida Cancer Specialists - South
Fort Myers Florida, 33901, United States More Info
Donna-May Bernard
Contact
239-274-9930
[email protected]
Elizabeth Guancial
Principal Investigator
University of Miami
Miami Florida, 33136, United States More Info
Violeta Milic
Contact
305-243-5181
[email protected]
Marilyn Huang
Principal Investigator
Florida Cancer Specialist North Division
Saint Petersburg Florida, 33705, United States More Info
Cara O'Keefe
Contact
239-274-9930
[email protected]
Gail Wright
Principal Investigator
Florida Cancer Specialists - Panhandle
Tallahassee Florida, 32308, United States More Info
Rebecca Johnson
Contact
703-280-5390
[email protected]
Margarett Ellison
Principal Investigator
Florida Cancer Specialist East Division
West Palm Beach Florida, 33401, United States More Info
Krystal Sanchez
Contact
561-366-4100
[email protected]
Daniel Spitz
Principal Investigator
Women's Cancer Center
Covington Louisiana, 70433, United States More Info
Cheryl Thomas
Contact
985-317-6005
[email protected]
Patricia Braly
Principal Investigator
Maine Medical Partners - Women's Health
Scarborough Maine, 04074, United States More Info
Robin Donovan
Contact
207-396-7089
[email protected]
Leslie Bradford
Principal Investigator
Tufts Medical Center
Boston Massachusetts, 02111, United States More Info
Megan Carney
Contact
617-636-2616
[email protected]
Young Kim
Principal Investigator
Baystate Medical Center
Springfield Massachusetts, 01199, United States More Info
Laura Sorci
Contact
413-794-3188
[email protected]
Tashanna Myers
Principal Investigator
Washington University School of Medicine
Saint Louis Missouri, 63108, United States More Info
Sarah Drake
Contact
314-362-3218
[email protected]
Premal Thaker
Principal Investigator
Holy Name Medical Center
Teaneck New Jersey, 07666, United States More Info
Marissa VanOrden
Contact
201-541-6312
[email protected]
Sharyn Lewin
Principal Investigator
Duke University
Durham North Carolina, 27710, United States More Info
Jennifer Mewshaw
Contact
919-668-1070
[email protected]
Angeles Secord
Principal Investigator
Cleveland Clinic Fairview Hospital-Moll Cancer Center
Cleveland Ohio, 44111, United States More Info
Sam Pifer
Contact
216-476-9809
[email protected]
Peter Rose
Principal Investigator
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States More Info
Sam Pifer
Contact
216-476-9809
[email protected]
Peter Rose
Principal Investigator
Zangmeister Cancer Center / Sarah Cannon Research Institute
Columbus Ohio, 43129, United States More Info
Katie Szeligo
Contact
[email protected]
Emily Whitman
Principal Investigator
Hillcrest Hospital: North Campus
Mayfield Heights Ohio, 44124, United States More Info
Sam Pifer
Contact
216-476-9809
[email protected]
Peter Rose
Principal Investigator
OU Health Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States More Info
Leslie Katona
Contact
267-844-2487
[email protected]
Debra Richardson
Principal Investigator
Willamette Valley Cancer Institute and Research Center
Eugene Oregon, 97401, United States More Info
Jeanne Schaffer
Contact
503-528-5005
[email protected]
Charles Anderson
Principal Investigator
Northwest Cancer Specialist, P.C.
Portland Oregon, 97227, United States More Info
Erin Salinas
Contact
503-528-5005
[email protected]
Erin Salinas
Principal Investigator
Women & Infants Hospital of Rhode Island Oncology Research
Providence Rhode Island, 02905, United States More Info
Emma Locke
Contact
401-453-7520
[email protected]
Cara Mathews
Principal Investigator
Tennessee Oncology / Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States More Info
Erika Hamilton
Principal Investigator
Texas Oncology-South Austin
Austin Texas, 78745, United States More Info
Monica Arellano
Contact
512-427-9400
[email protected]
Lynne Knowles
Principal Investigator
Texas Oncology - Dallas Presbyterian
Dallas Texas, 75231, United States More Info
Nancy Jones
Contact
214-739-4175
[email protected]
Kristi McIntyre
Principal Investigator
Texas Oncology
The Woodlands Texas, 77380, United States More Info
Veta Clayton
Contact
281-296-0365
[email protected]
Christine Lee
Principal Investigator
Virginia Cancer Specialists, PC
Gainesville Virginia, 20155, United States More Info
Marcy Sullivan
Contact
703-280-5390
[email protected]
Robert Marsh
Principal Investigator
Virginia Oncology Associates
Norfolk Virginia, 23502, United States More Info
Jenny Marks
Contact
757-873-9832
[email protected]
Michael McCollum
Principal Investigator
Kadlec Clinic Hematology & Oncology
Kennewick Washington, 99336, United States More Info
Cheryl Albin
Contact
509-783-4637
[email protected]
Ying Zhuo
Principal Investigator
Newcastle Private Hospital
New Lambton Heights New South Wales, 2305, Australia More Info
Clare Fischer
Contact
(+61) 2 4941 8784
[email protected]
Antonino Bonaventura
Principal Investigator
Royal North Shore Hospital
St. Leonards New South Wales, 2065, Australia More Info
Connie Diakos
Principal Investigator
Burnside War Memorial Hospital - The Brian Fricker Oncology Centre
Toorak Gardens South Australia, 5065, Australia More Info
Diana Caruso
Contact
[email protected]
Martin K Oehler
Principal Investigator
Monash Health
Clayton Victoria, 3165, Australia More Info
Kate Webber
Principal Investigator
Cabrini Hospital Malvern
Malvern Victoria, 3144, Australia More Info
Gary Richardson
Principal Investigator
St John of God Subiaco Hospital
Subiaco Western Australia, 6008, Australia More Info
Gabrielle Jones
Contact
+61 8 6465-9024
[email protected]
Andrew Dean
Principal Investigator
UZ Gent
Gent , 9000, Belgium More Info
Lore Vanstelelant
Contact
+32 9 332 57 93
[email protected]
Hannelore Denys
Principal Investigator
UZ Leuven
Leuven , 3000, Belgium More Info
Charlien Janssen
Contact
(+32) 16 34 17 64
[email protected]
Toon Van Gorp
Principal Investigator
CHU UCL
Namur , 5000, Belgium More Info
Dominique Crasson
Contact
3281702844
[email protected]
Stephanie Henry
Principal Investigator
Princess Margaret Cancer Centre - University Health Network
Toronto Ontario, M5G 2, Canada More Info
Vivian Feng
Contact
416-946-4501
[email protected]
Amit Oza
Principal Investigator
McGill University Health Center
Montréal Quebec, H4A 3, Canada More Info
Nathalie Phuong-Nam Nguyen
Contact
514-934-1934
[email protected]
Xing Zeng
Principal Investigator
Ciussse-Chus
Sherbrooke Quebec, J1H 5, Canada More Info
Annie Bourbonnais
Contact
819-346-1110
Paul Bessette
Principal Investigator
Centre Oscar Lambret
Lille , 59020, France More Info
Clémence GOETZ
Contact
+33 (0)3 20 29 56 18
[email protected]
Stéphanie Becourt
Principal Investigator
Centre Léon Bérard
Lyon , 69373, France More Info
Mélanie Emin
Contact
+ 33426556842
[email protected]
Isabelle Ray-Coquard
Principal Investigator
Institut Poali Calmette
Marseille , 13009, France More Info
Pauline COMTE
Contact
[email protected]
Magali Provansal
Principal Investigator
Groupe Hospitalier Diaconesse, Croix Saint-Simon
Paris , 75020, France More Info
Sonia Branco
Contact
33144741008
[email protected]
Antoine Angelergues
Principal Investigator
Centre Hospitalier Lyon Sud
Pierre-Bénite , 69310, France More Info
Christine Gerentet
Contact
33478861771
[email protected]
Benoît You
Principal Investigator
Centre CARIO - HPCA
Plerin , 22190, France More Info
Aude Vincent
Contact
02 57 24 02 43
[email protected]
Anne-Claire Hardy-Bessard
Principal Investigator
ICO Centre Rene Gauducheau
Saint-Herblain Cedex , 44805, France More Info
Sarah Glize
Contact
+33(0)240679900
[email protected]
Dominique Berton-Rigaud
Principal Investigator
Institut de Cancerologie Strabsourg Europe Unité de recherche clinique
Strasbourg , 67033, France More Info
Valérie Satori
Contact
33368767223
[email protected]
Laurianne Eberst
Principal Investigator
Bon Secours Hospital
Cork , 00, Ireland More Info
Evelyn O'Sullivan Greene
Contact
353 021 4542807
[email protected]
Conleth Murphy
Principal Investigator
St James's Hospital
Dublin , D08 N, Ireland More Info
Claire O'Donohoe
Contact
00353 1 410 3750
[email protected]
Karen Cadoo
Principal Investigator
Beaumont Hospital
Dublin , D09 V, Ireland More Info
Keith Egan
Contact
35318092010
[email protected]
Patrick Morris
Principal Investigator
Mater Misericordiae University Hospital
Dublin , , Ireland More Info
Bindu KRISHNANIVAS
Contact
+353 18034834
[email protected]
Austin Duffy
Principal Investigator
University Hospital Waterford
Waterford , X91 E, Ireland More Info
Elaine Shanahan
Contact
+ 353 51 848934
[email protected]
Paula Calvert
Principal Investigator
Azienda Ospedaliero-Universitaria-IRCCS
Bologna , 40138, Italy More Info
Cinzia Pizzirani
Contact
+39 0512144447
[email protected]
Claudio Zamagni
Principal Investigator
Osperdale Cannizzaro di Catania
Catania , 95126, Italy More Info
Alessandra Paggin
Contact
390957262720
[email protected]
Paolo Scollo
Principal Investigator
IRCCS - Istituto Europeo di Oncologia
Milano , 20141, Italy More Info
Abbondanza Montinaro
Contact
+39 0257489935
[email protected]
Nicoletta Colombo
Principal Investigator
Istituto Nazionale Tumori Napoli
Napoli , 80131, Italy More Info
Angela Trujillo
Contact
390825903410
[email protected]
Sandro Pignata
Principal Investigator
Azienda Unita Sanitaria Locale di Ravenna
Ravenna , 48100, Italy More Info
Maria-Theresa Tangari
Contact
544287175
[email protected]
Stefano Tamberi
Principal Investigator
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma , 168, Italy More Info
Sonia Borrelli
Contact
0039 339 413 8119
[email protected]
Vanda Salutari
Principal Investigator
ClÃ-nica Universidad de Navarra (CUN)
Pamplona Madrid, 28027, Spain More Info
Covadonga Vidal Garcia
Contact
34 913531920
[email protected]
Antonio Gonzalez-Martin
Principal Investigator
Institut Català d'Oncologia - Hospital Universitari Germans Trias i Pujol, Unidad de Investigación Clínica, Servicio de Oncología, Institut Josep Carreres (IJC, 1ª planta)
Badalona , 08916, Spain More Info
Margarita Romeo-Marin
Principal Investigator
Vall d'Hebron Institute of Oncology
Barcelona , 08035, Spain More Info
Ana Oaknin
Principal Investigator
Institut Català d' Oncologia L' Hospitalet
Barcelona , 8908, Spain More Info
Veronica De Michele
Contact
+34 93 335 70 11
[email protected]
Beatriz Pardo-Burdalo
Principal Investigator
Complejo Hospitalario Provincial de Castellón
Castelló , 12002, Spain More Info
Regina Romero
Contact
964 376 240
[email protected]
Nuria Ruiz
Principal Investigator
Hospital Reina Sofia
Cordoba , 14004, Spain More Info
Maria José Marin
Contact
+34 957011456
[email protected]
Maria Jesus Rubio
Principal Investigator
Hospital Universitario HU de Jaen
Jaen , 23007, Spain More Info
María Ruiz-Sanjuan Ruiz-Sanjuan
Contact
(+34) 953220306
[email protected]
Fernando Galvez
Principal Investigator
Hospital MD Anderson Cancer Center Madrid
Madrid , 28033, Spain More Info
Silvia Garcia Garro
Contact
+34 91 787 86 00
[email protected]
Raul Marquez
Principal Investigator
Hospital de San Chinarro-Clara Campal
Madrid , 28050, Spain More Info
Patricia Morgades
Contact
0034 91 756 78 00
[email protected]
Arantzazu Barquin
Principal Investigator
Hospital La Paz
Madrid , , Spain More Info
Yolanda Alvarez Pérez
Contact
34917277516
[email protected]
Andres Redondo
Principal Investigator
Virgen del Rocío
Sevilla , 41013, Spain More Info
Cristina De Silva
Contact
34 955013622
[email protected]
Purificación Estévez
Principal Investigator
Hospital Clinico
Valencia , , Spain More Info
Veronica Babiano
Contact
+34 961973527
[email protected]
Alejandro Perez-Fidalgo
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

75

Study ID:

NCT05041257

Recruitment Status:

Recruiting

Sponsor:


ImmunoGen, Inc.

How clear is this clinincal trial information?

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