Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian Tube Cancers (PICCOLO)
NCT ID: NCT05041257
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
79 participants
INTERVENTIONAL
2021-08-31
2024-12-12
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mirvetuximab Soravtansine
Participants will receive MIRV 6.0 mg/kg adjusted by ideal body weight (AIBW)
Mirvetuximab soravtansine
Administered by intravenous (IV) infusion on Day 1 of every 3-week cycle
Interventions
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Mirvetuximab soravtansine
Administered by intravenous (IV) infusion on Day 1 of every 3-week cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
3. Patients must have a confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer
4. 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
5. Patients must have progressed radiographically on or after their most recent line of anticancer therapy
6. Patients must have at least 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the Investigator)
7. 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
8. Patient's tumor must be positive for FRα expression as defined by the Ventana FOLR1 Assay
9. Prior anticancer therapy
1. 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
2. Patients may have received up to but no more than 1 prior independent non-platinum cytotoxic therapy
3. 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
4. Neoadjuvant ± adjuvant therapies are considered 1 line of therapy
5. Maintenance therapy (eg, bevacizumab, PARP inhibitors) will be considered part of the preceding line of therapy (ie, not counted independently)
6. Therapy changed due to toxicity in the absence of progression will be considered part of the same line (ie, not counted independently)
10. Patients must have completed prior therapy within the specified times below:
1. Systemic antineoplastic therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to first dose of MIRV
2. Focal radiation completed at least 2 weeks prior to first dose of MIRV
11. Patients must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia)
12. 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
13. Patients must have adequate hematologic, liver and kidney functions defined as:
1. 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
2. Platelet count ≥ 100 x 10\^9/L (100,000/μL) without platelet transfusion in the prior 10 days
3. Hemoglobin ≥ 9.0 g/dL without packed red blood cell (PRBC) transfusion in the prior 21 days
4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN
6. Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \< 3.0 x ULN)
7. Serum albumin ≥ 2 g/dL
14. Patients must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements
15. 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
16. WCBP must have a negative pregnancy test within the 4 days prior to the first dose of MIRV
Exclusion Criteria
2. Patients with prior wide-field radiotherapy (RT) affecting at least 20% of the bone marrow
3. Patients with \> Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE)
4. 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
5. Patients with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:
1. Active hepatitis B or C infection (whether or not on active antiviral therapy)
2. HIV infection
3. Active cytomegalovirus infection
4. 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.
6. Patients with a history of multiple sclerosis (MS) or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
7. Patients with clinically significant cardiac disease including, but not limited to, any of the following:
1. Myocardial infarction ≤ 6 months prior to first dose
2. Unstable angina pectoris
3. Uncontrolled congestive heart failure (New York Heart Association \> class II)
4. Uncontrolled ≥ Grade 3 hypertension (per CTCAE)
5. Uncontrolled cardiac arrhythmias
8. Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment
9. Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)
10. Patients with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including noninfectious pneumonitis
11. Patients requiring use of folate-containing supplements (eg, folate deficiency)
12. Patients with prior hypersensitivity to monoclonal antibodies (mAb)
13. Women who are pregnant or breastfeeding
14. Patients who received prior treatment with MIRV or other FRα-targeting agents
15. Patients with untreated or symptomatic central nervous system (CNS) metastases
16. 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.
17. Prior known hypersensitivity reactions to study drugs and/or any of their excipients
18 Years
FEMALE
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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The University of Alabama at Birmingham - Division of Gynecology Oncology O'Neal Comprehensive Cancer Center
Birmingham, Alabama, United States
Alaska Women's Cancer Care/Providence Alaska Medical Center
Anchorage, Alaska, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
City of Hope
Duarte, California, United States
UCLA-JCCC Dept of OBGYN - Women's Health Clinical Research Unit
Los Angeles, California, United States
University of Colorado School of Medicine
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Florida Cancer Specialists - South
Fort Myers, Florida, United States
University of Miami
Miami, Florida, United States
Florida Cancer Specialist North Division
St. Petersburg, Florida, United States
Florida Cancer Specialists - Panhandle
Tallahassee, Florida, United States
Florida Cancer Specialist East Division
West Palm Beach, Florida, United States
Women's Cancer Center
Covington, Louisiana, United States
Maine Medical Partners - Women's Health
Scarborough, Maine, United States
Tufts Medical Center
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
Duke University
Durham, North Carolina, United States
Cleveland Clinic Fairview Hospital-Moll Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Zangmeister Cancer Center / Sarah Cannon Research Institute
Columbus, Ohio, United States
Hillcrest Hospital: North Campus
Mayfield Heights, Ohio, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
Northwest Cancer Specialist, P.C.
Portland, Oregon, United States
Women & Infants Hospital of Rhode Island Oncology Research
Providence, Rhode Island, United States
Tennessee Oncology / Sarah Cannon Research Institute
Nashville, Tennessee, United States
Texas Oncology-South Austin
Austin, Texas, United States
Texas Oncology - Dallas Presbyterian
Dallas, Texas, United States
Texas Oncology
The Woodlands, Texas, United States
Virginia Cancer Specialists, PC
Gainesville, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Kadlec Clinic Hematology & Oncology
Kennewick, Washington, United States
Newcastle Private Hospital
New Lambton Heights, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Burnside War Memorial Hospital - The Brian Fricker Oncology Centre
Toorak Gardens, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
Cabrini Hospital Malvern
Malvern, Victoria, Australia
St John of God Subiaco Hospital
Subiaco, Western Australia, Australia
UZ Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
CHU UCL
Namur, , Belgium
Princess Margaret Cancer Centre - University Health Network
Toronto, Ontario, Canada
McGill University Health Center
Montreal, Quebec, Canada
Ciussse-Chus
Sherbrooke, Quebec, Canada
Centre Oscar Lambret
Lille, , France
Centre Léon Bérard
Lyon, , France
Institut Poali Calmette
Marseille, , France
Groupe Hospitalier Diaconesse, Croix Saint-Simon
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre CARIO - HPCA
Plérin, , France
ICO Centre Rene Gauducheau
Saint-Herblain, , France
Institut de Cancerologie Strabsourg Europe Unité de recherche clinique
Strasbourg, , France
Bon Secours Hospital
Cork, , Ireland
St James's Hospital
Dublin, , Ireland
Beaumont Hospital
Dublin, , Ireland
Mater Misericordiae University Hospital
Dublin, , Ireland
University Hospital Waterford
Waterford, , Ireland
Azienda Ospedaliero-Universitaria-IRCCS
Bologna, , Italy
Osperdale Cannizzaro di Catania
Catania, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
IRCCS - Istituto Europeo di Oncologia
Milan, , Italy
Istituto Nazionale Tumori Napoli
Napoli, , Italy
Azienda Unita Sanitaria Locale di Ravenna
Ravenna, , Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, , Italy
ClÃ-nica Universidad de Navarra (CUN)
Pamplona, Madrid, Spain
Institut Català d'Oncologia - Hospital Universitari Germans Trias i Pujol, Unidad de Investigación Clínica, Servicio de Oncología, Institut Josep Carreres (IJC, 1ª planta)
Badalona, , Spain
Vall d'Hebron Institute of Oncology
Barcelona, , Spain
Institut Català d' Oncologia L' Hospitalet
Barcelona, , Spain
Complejo Hospitalario Provincial de Castellón
Castelló, , Spain
Hospital Reina Sofia
Córdoba, , Spain
Hospital Universitario HU de Jaen
Jaén, , Spain
Hospital MD Anderson Cancer Center Madrid
Madrid, , Spain
Hospital de San Chinarro-Clara Campal
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
Virgen del Rocío
Seville, , Spain
Hospital Clinico
Valencia, , Spain
Countries
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References
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Alvarez Secord A, Lewin SN, Murphy CG, Cecere SC, Barquin A, Galvez-Montosa F, Mathews CA, Konecny GE, Ray-Coquard I, Oaknin A, Rubio Perez MJ, Bonaventura A, Diver EJ, Ayuk SM, Wang Y, Corr BR, Salutari V. The efficacy and safety of mirvetuximab soravtansine in FRalpha-positive, third-line and later, recurrent platinum-sensitive ovarian cancer: the single-arm phase II PICCOLO trial. Ann Oncol. 2025 Mar;36(3):321-330. doi: 10.1016/j.annonc.2024.11.011. Epub 2024 Nov 29.
Related Links
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Other Identifiers
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IMGN853-0419
Identifier Type: -
Identifier Source: org_study_id