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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05041257




Registration number
NCT05041257
Ethics application status
Date submitted
24/08/2021
Date registered
13/09/2021

Titles & IDs
Public title
Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian Tube Cancers (PICCOLO)
Scientific 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)
Secondary ID [1] 0 0
IMGN853419
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Peritoneal Cancer 0 0
Fallopian Tube Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mirvetuximab soravtansine

Experimental: Mirvetuximab Soravtansine - Participants will receive MIRV 6.0 mg/kg adjusted by ideal body weight (AIBW)


Treatment: Drugs: Mirvetuximab soravtansine
Administered by intravenous (IV) infusion on Day 1 of every 3-week cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assess Objective Response Rate
Timepoint [1] 0 0
up to 2 years
Secondary outcome [1] 0 0
Assess Duration of response (DOR)
Timepoint [1] 0 0
up to 2 years
Secondary outcome [2] 0 0
Assess treatment emergent adverse events (TEAEs)
Timepoint [2] 0 0
up to 2 years
Secondary outcome [3] 0 0
Assess Cancer Antigen-125
Timepoint [3] 0 0
up to 2 years
Secondary outcome [4] 0 0
Assess Progression-free survival (PFS)
Timepoint [4] 0 0
up to 2 years
Secondary outcome [5] 0 0
Assess Overall survival (OS)
Timepoint [5] 0 0
up to 2 years
Secondary outcome [6] 0 0
Sensitivity analysis
Timepoint [6] 0 0
up to 2 years

Eligibility
Key inclusion criteria
Key

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 FRa positivity
8. Patient's tumor must be positive for FRa 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
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 FRa-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

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/12/2024
Actual
Sample size
Target
Accrual to date
Final
79
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [3] 0 0
Burnside War Memorial Hospital - The Brian Fricker Oncology Centre - Toorak Gardens
Recruitment hospital [4] 0 0
Monash Health - Clayton
Recruitment hospital [5] 0 0
Cabrini Hospital Malvern - Malvern
Recruitment hospital [6] 0 0
St John of God Subiaco Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment postcode(s) [3] 0 0
5065 - Toorak Gardens
Recruitment postcode(s) [4] 0 0
3165 - Clayton
Recruitment postcode(s) [5] 0 0
3144 - Malvern
Recruitment postcode(s) [6] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maine
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Rhode Island
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Belgium
State/province [22] 0 0
Gent
Country [23] 0 0
Belgium
State/province [23] 0 0
Leuven
Country [24] 0 0
Belgium
State/province [24] 0 0
Namur
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
France
State/province [27] 0 0
Lille
Country [28] 0 0
France
State/province [28] 0 0
Lyon
Country [29] 0 0
France
State/province [29] 0 0
Marseille
Country [30] 0 0
France
State/province [30] 0 0
Paris
Country [31] 0 0
France
State/province [31] 0 0
Pierre-Bénite
Country [32] 0 0
France
State/province [32] 0 0
Plerin
Country [33] 0 0
France
State/province [33] 0 0
Saint-Herblain Cedex
Country [34] 0 0
France
State/province [34] 0 0
Strasbourg
Country [35] 0 0
Ireland
State/province [35] 0 0
Cork
Country [36] 0 0
Ireland
State/province [36] 0 0
Dublin
Country [37] 0 0
Ireland
State/province [37] 0 0
Waterford
Country [38] 0 0
Italy
State/province [38] 0 0
Bologna
Country [39] 0 0
Italy
State/province [39] 0 0
Catania
Country [40] 0 0
Italy
State/province [40] 0 0
Milano
Country [41] 0 0
Italy
State/province [41] 0 0
Napoli
Country [42] 0 0
Italy
State/province [42] 0 0
Ravenna
Country [43] 0 0
Italy
State/province [43] 0 0
Roma
Country [44] 0 0
Spain
State/province [44] 0 0
Madrid
Country [45] 0 0
Spain
State/province [45] 0 0
Badalona
Country [46] 0 0
Spain
State/province [46] 0 0
Barcelona
Country [47] 0 0
Spain
State/province [47] 0 0
Castelló
Country [48] 0 0
Spain
State/province [48] 0 0
Cordoba
Country [49] 0 0
Spain
State/province [49] 0 0
Jaen
Country [50] 0 0
Spain
State/province [50] 0 0
Sevilla
Country [51] 0 0
Spain
State/province [51] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ImmunoGen, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05041257