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

Primary Purpose

Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Mirvetuximab soravtansine
Sponsored by
ImmunoGen, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Platinum-sensitive, Ovarian cancer, Folate-receptor alpha expression, Antibody-drug conjugate, Cancer, Ovarian Neoplasma, Recurrent Platinum-Sensitive,, High-Grade Ovarian, PICCOLO

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Key Inclusion Criteria:

  1. Patients ≥ 18 years of age
  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

Key Exclusion Criteria-

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

Sites / Locations

  • The University of Alabama at Birmingham - Division of Gynecology Oncology O'Neal Comprehensive Cancer Center
  • Alaska Women's Cancer Care/Providence Alaska Medical Center
  • Arizona Oncology Associates, PC - HOPE
  • City of Hope
  • UCLA-JCCC Dept of OBGYN - Women's Health Clinical Research Unit
  • University of Colorado School of Medicine
  • Yale University School of Medicine
  • Florida Cancer Specialists - South
  • University of Miami
  • Florida Cancer Specialist North Division
  • Florida Cancer Specialists - Panhandle
  • Florida Cancer Specialist East Division
  • Women's Cancer Center
  • Maine Medical Partners - Women's Health
  • Tufts Medical Center
  • Baystate Medical Center
  • Washington University School of Medicine
  • Holy Name Medical Center
  • Duke University
  • Cleveland Clinic Fairview Hospital-Moll Cancer Center
  • Cleveland Clinic Foundation
  • Zangmeister Cancer Center / Sarah Cannon Research Institute
  • Hillcrest Hospital: North Campus
  • OU Health Stephenson Cancer Center
  • Willamette Valley Cancer Institute and Research Center
  • Northwest Cancer Specialist, P.C.
  • Women & Infants Hospital of Rhode Island Oncology Research
  • Tennessee Oncology / Sarah Cannon Research Institute
  • Texas Oncology-South Austin
  • Texas Oncology - Dallas Presbyterian
  • Texas Oncology
  • Virginia Cancer Specialists, PC
  • Virginia Oncology Associates
  • Kadlec Clinic Hematology & Oncology
  • Newcastle Private Hospital
  • Royal North Shore Hospital
  • Burnside War Memorial Hospital - The Brian Fricker Oncology Centre
  • Monash Health
  • Cabrini Hospital Malvern
  • St John of God Subiaco Hospital
  • UZ Gent
  • UZ Leuven
  • CHU UCL
  • Princess Margaret Cancer Centre - University Health Network
  • McGill University Health Center
  • Ciussse-Chus
  • Centre Oscar Lambret
  • Centre Léon Bérard
  • Institut Poali Calmette
  • Groupe Hospitalier Diaconesse, Croix Saint-Simon
  • Centre Hospitalier Lyon Sud
  • Centre CARIO - HPCA
  • ICO Centre Rene Gauducheau
  • Institut de Cancerologie Strabsourg Europe Unité de recherche clinique
  • Bon Secours Hospital
  • St James's Hospital
  • Beaumont Hospital
  • Mater Misericordiae University Hospital
  • University Hospital Waterford
  • Azienda Ospedaliero-Universitaria-IRCCS
  • Osperdale Cannizzaro di Catania
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • IRCCS - Istituto Europeo di Oncologia
  • Istituto Nazionale Tumori Napoli
  • Azienda Unita Sanitaria Locale di Ravenna
  • Fondazione Policlinico Universitario A. Gemelli IRCCS
  • ClÃ-nica Universidad de Navarra (CUN)
  • Institut Català d'Oncologia - Hospital Universitari Germans Trias i Pujol, Unidad de Investigación Clínica, Servicio de Oncología, Institut Josep Carreres (IJC, 1ª planta)
  • Vall d'Hebron Institute of Oncology
  • Institut Català d' Oncologia L' Hospitalet
  • Complejo Hospitalario Provincial de Castellón
  • Hospital Reina Sofia
  • Hospital Universitario HU de Jaen
  • Hospital MD Anderson Cancer Center Madrid
  • Hospital de San Chinarro-Clara Campal
  • Hospital La Paz
  • Virgen del Rocío
  • Hospital Clinico

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mirvetuximab Soravtansine

Arm Description

Participants will receive MIRV 6.0 mg/kg adjusted by ideal body weight (AIBW)

Outcomes

Primary Outcome Measures

Assess Objective Response Rate
Objective response rate (ORR), which includes confirmed best response of complete response (CR) or partial response (PR) as assessed by the Investigator

Secondary Outcome Measures

Assess Duration of response (DOR)
Duration of response (DOR), defined as the time from initial Investigator-assessed response (CR or PR) until progressive disease (PD) as assessed by the Investigator
Assess treatment emergent adverse events (TEAEs)
Adverse Events (AE's) will be evaluated according to the NCI CTCAE v5.0. AEs will be coded using the latest Medical Dictionary for Regulatory Activities (MedDRA) version and summarized per system organ class (SOC) and preferred term
Assess Cancer Antigen-125
Cancer Antigen-125 response determined using the Gynecologic Cancer Intergroup (GCIG) criteria
Assess Progression-free survival (PFS)
Progression-free survival (PFS), defined as the time from first dose of MIRV until Investigator-assessed radiological PD or death, whichever occurs first
Assess Overall survival (OS)
Overall survival (OS), defined as the time from first dose of MIRV until death
Sensitivity analysis
ORR, DOR, and PFS by blinded independent central review (BICR) will be summarized as sensitivity analysis

Full Information

First Posted
August 24, 2021
Last Updated
October 24, 2023
Sponsor
ImmunoGen, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05041257
Brief Title
Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian Tube Cancers (PICCOLO)
Official Title
A Phase 2, Single Arm Study of Mirvetuximab Soravtansine in Recurrent Platinum-Sensitive, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression (PICCOLO)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 31, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImmunoGen, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
Keywords
Platinum-sensitive, Ovarian cancer, Folate-receptor alpha expression, Antibody-drug conjugate, Cancer, Ovarian Neoplasma, Recurrent Platinum-Sensitive,, High-Grade Ovarian, PICCOLO

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Mirvetuximab Soravtansine
Arm Type
Experimental
Arm Description
Participants will receive MIRV 6.0 mg/kg adjusted by ideal body weight (AIBW)
Intervention Type
Drug
Intervention Name(s)
Mirvetuximab soravtansine
Other Intervention Name(s)
MIRV, IMGN853
Intervention Description
Administered by intravenous (IV) infusion on Day 1 of every 3-week cycle
Primary Outcome Measure Information:
Title
Assess Objective Response Rate
Description
Objective response rate (ORR), which includes confirmed best response of complete response (CR) or partial response (PR) as assessed by the Investigator
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Assess Duration of response (DOR)
Description
Duration of response (DOR), defined as the time from initial Investigator-assessed response (CR or PR) until progressive disease (PD) as assessed by the Investigator
Time Frame
up to 2 years
Title
Assess treatment emergent adverse events (TEAEs)
Description
Adverse Events (AE's) will be evaluated according to the NCI CTCAE v5.0. AEs will be coded using the latest Medical Dictionary for Regulatory Activities (MedDRA) version and summarized per system organ class (SOC) and preferred term
Time Frame
up to 2 years
Title
Assess Cancer Antigen-125
Description
Cancer Antigen-125 response determined using the Gynecologic Cancer Intergroup (GCIG) criteria
Time Frame
up to 2 years
Title
Assess Progression-free survival (PFS)
Description
Progression-free survival (PFS), defined as the time from first dose of MIRV until Investigator-assessed radiological PD or death, whichever occurs first
Time Frame
up to 2 years
Title
Assess Overall survival (OS)
Description
Overall survival (OS), defined as the time from first dose of MIRV until death
Time Frame
up to 2 years
Title
Sensitivity analysis
Description
ORR, DOR, and PFS by blinded independent central review (BICR) will be summarized as sensitivity analysis
Time Frame
up to 2 years

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
The University of Alabama at Birmingham - Division of Gynecology Oncology O'Neal Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Alaska Women's Cancer Care/Providence Alaska Medical Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Arizona Oncology Associates, PC - HOPE
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
UCLA-JCCC Dept of OBGYN - Women's Health Clinical Research Unit
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of Colorado School of Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8063
Country
United States
Facility Name
Florida Cancer Specialists - South
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Florida Cancer Specialist North Division
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Florida Cancer Specialists - Panhandle
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Florida Cancer Specialist East Division
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Women's Cancer Center
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Maine Medical Partners - Women's Health
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Holy Name Medical Center
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic Fairview Hospital-Moll Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Zangmeister Cancer Center / Sarah Cannon Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43129
Country
United States
Facility Name
Hillcrest Hospital: North Campus
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
OU Health Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Willamette Valley Cancer Institute and Research Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Northwest Cancer Specialist, P.C.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Women & Infants Hospital of Rhode Island Oncology Research
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Tennessee Oncology / Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology-South Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Texas Oncology - Dallas Presbyterian
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Texas Oncology
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Gainesville
State/Province
Virginia
ZIP/Postal Code
20155
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Kadlec Clinic Hematology & Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Newcastle Private Hospital
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Royal North Shore Hospital
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Burnside War Memorial Hospital - The Brian Fricker Oncology Centre
City
Toorak Gardens
State/Province
South Australia
ZIP/Postal Code
5065
Country
Australia
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Cabrini Hospital Malvern
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
St John of God Subiaco Hospital
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU UCL
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Princess Margaret Cancer Centre - University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
McGill University Health Center
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3H1
Country
Canada
Facility Name
Ciussse-Chus
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Institut Poali Calmette
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Groupe Hospitalier Diaconesse, Croix Saint-Simon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Facility Name
Centre CARIO - HPCA
City
Plerin
ZIP/Postal Code
22190
Country
France
Facility Name
ICO Centre Rene Gauducheau
City
Saint-Herblain Cedex
ZIP/Postal Code
44805
Country
France
Facility Name
Institut de Cancerologie Strabsourg Europe Unité de recherche clinique
City
Strasbourg
ZIP/Postal Code
67033
Country
France
Facility Name
Bon Secours Hospital
City
Cork
ZIP/Postal Code
00
Country
Ireland
Facility Name
St James's Hospital
City
Dublin
ZIP/Postal Code
D08 NHY1
Country
Ireland
Facility Name
Beaumont Hospital
City
Dublin
ZIP/Postal Code
D09 V2N0
Country
Ireland
Facility Name
Mater Misericordiae University Hospital
City
Dublin
Country
Ireland
Facility Name
University Hospital Waterford
City
Waterford
ZIP/Postal Code
X91 ER8E
Country
Ireland
Facility Name
Azienda Ospedaliero-Universitaria-IRCCS
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Osperdale Cannizzaro di Catania
City
Catania
ZIP/Postal Code
95126
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
IRCCS - Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Istituto Nazionale Tumori Napoli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Unita Sanitaria Locale di Ravenna
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
Facility Name
Fondazione Policlinico Universitario A. Gemelli IRCCS
City
Roma
ZIP/Postal Code
168
Country
Italy
Facility Name
ClÃ-nica Universidad de Navarra (CUN)
City
Pamplona
State/Province
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Institut Català d'Oncologia - Hospital Universitari Germans Trias i Pujol, Unidad de Investigación Clínica, Servicio de Oncología, Institut Josep Carreres (IJC, 1ª planta)
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Vall d'Hebron Institute of Oncology
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Institut Català d' Oncologia L' Hospitalet
City
Barcelona
ZIP/Postal Code
8908
Country
Spain
Facility Name
Complejo Hospitalario Provincial de Castellón
City
Castelló
ZIP/Postal Code
12002
Country
Spain
Facility Name
Hospital Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario HU de Jaen
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Facility Name
Hospital MD Anderson Cancer Center Madrid
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital de San Chinarro-Clara Campal
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
Country
Spain
Facility Name
Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clinico
City
Valencia
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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