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    Summary
    EudraCT Number:2020-000179-19
    Sponsor's Protocol Code Number:IMGN853-0417
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-07-29
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-000179-19
    A.3Full title of the trial
    SORAYA: A Phase 3, Single Arm Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test mirvetuximab soravtansine in women with platinum-resistant, advanced epithelial ovarian, primary peritoneal, or fallopian tube cancers
    A.3.2Name or abbreviated title of the trial where available
    SORAYA
    A.4.1Sponsor's protocol code numberIMGN853-0417
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04296890
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorImmunoGen, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportImmunoGen, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImmunoGen, Inc.
    B.5.2Functional name of contact pointPatrick Zweidler-McKay
    B.5.3 Address:
    B.5.3.1Street Address830 Winter Street
    B.5.3.2Town/ cityWaltham
    B.5.3.3Post codeMA 02451
    B.5.3.4CountryUnited States
    B.5.6E-mailpatrick.zweidler-mckay@immunogen.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/15/1458
    D.3 Description of the IMP
    D.3.1Product namemirvetuximab soravtansine
    D.3.2Product code IMGN853
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMIRVETUXIMAB SORAVTANSINE
    D.3.9.1CAS number 1453084-37-1
    D.3.9.2Current sponsor codeIMGN853
    D.3.9.4EV Substance CodeSUB181124
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression
    E.1.1.1Medical condition in easily understood language
    Cancer of ovary and related organs
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10061269
    E.1.2Term Malignant peritoneal neoplasm
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061328
    E.1.2Term Ovarian epithelial cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10016180
    E.1.2Term Fallopian tube cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To determine the efficacy of mirvetuximab soravtansine in patients with platinum-resistant ovarian cancer (PROC) and high folate receptor alpha (FRα) expression
    E.2.2Secondary objectives of the trial
    Key Secondary Objective
    •To determine the durability of response to mirvetuximab soravtansine in patients with PROC and high FRα expression
    Additional Secondary Objectives
    •To evaluate the safety and tolerability of mirvetuximab soravtansine
    •To characterize the clinical activity of mirvetuximab soravtansine in patients with PROC and high FRα expression
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Female patients ≥ 18 years of age
    2.Patients must have a confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer
    3. Patients must have platinum-resistant disease:
    a. Patients who have only had 1 line of platinum based therapy must have received at least 4 cycles of platinum, must have had a response (CR or PR) and then progressed between > 3 months and ≤ 6 months after the date of the last dose of platinum
    b. Patients who have received 2 or 3 lines of platinum therapy must have progressed on or within 6 months after the date of the last dose of platinum
    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
    Note: Patients who are platinum refractory during front-line treatment are excluded (see exclusion criteria)
    4. Patients must have progressed radiographically on or after their most recent line of anticancer therapy
    5. 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
    6. Patient’s tumor must be positive for FRα expression as defined by the Ventana FOLRI Assay
    7.Patients must have at least 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the Investigator)
    8.Patients must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy, including at least 1 line of therapy containing bevacizumab, and for whom single-agent therapy is appropriate as the next line of treatment:
    a.Adjuvant ± neoadjuvant considered 1 line of therapy
    b.Maintenance therapy (eg, bevacizumab, PARP inhibitors) will be considered part of the preceding line of therapy (ie, not counted independently)
    c.Therapy changed due to toxicity in the absence of progression will be considered part of the same line (ie, not counted independently)
    d.Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance
    9.Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
    10.Patients must have completed prior therapy within the specified times below:
    a.Systemic antineoplastic therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to first dose of mirvetuximab soravtansine
    b.Focal radiation completed at least 2 weeks prior to first dose of mirvetuximab soravtansine
    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 mirvetuximab soravtansine and have recovered or stabilized from the side effects of prior surgery
    13.Patients must have adequate hematologic, liver and kidney functions defined as:
    a. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1,500/μL) without G-CSF in the prior 10 days or long -acting WBC growth factors in the prior 20 days.
    b. Platelet count ≥ 100 x 109/L (100,000/μL) without platelet transfusion in the prior 10 days
    c. Hemoglobin ≥ 9.0 g/dL without packed red blood cell ( PRBC) transfusion in the prior 21 days
    d. Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
    e. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN
    f. Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 x ULN)
    g.Serum albumin ≥ 2 g/dL
    14.Patients or their legally authorized representative 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) (as defined in Section 5.8.6) while on mirvetuximab soravtansine 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 mirvetuximab soravtansine
    E.4Principal exclusion criteria
    1. Male patients
    2. Patients with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumor
    3. Patients with primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first-line platinum-containing chemotherapy
    4.Patients with prior wide-field radiotherapy (RT) affecting at least 20% of the bone marrow
    5.Patients with > Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE)
    6.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
    7.Patients with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:
    a. Active hepatitis B or C infection (whether or not on active antiviral therapy)
    b. Human immunodeficiency virus (HIV) infection
    c. Active Cytomegalovirus infection
    d. Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of mirvetuximab soravtansine
    Note: Testing at screening is not required for the above infections unless clinically indicated
    8.Patients with a history of multiple sclerosis (MS) or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
    9.Patients with clinically significant cardiac disease including, but not limited to, any of the following:
    a.Myocardial infarction ≤ 6 months prior to first dose
    b.Unstable angina pectoris
    c.Uncontrolled congestive heart failure (New York Heart Association > class II)
    d.Uncontrolled ≥ Grade 3 hypertension (per CTCAE)
    e.Uncontrolled cardiac arrhythmias
    10.Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment
    11.Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)
    12.Patients with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including noninfectious pneumonitis
    13.Patients requiring use of folate-containing supplements (eg, folate deficiency)
    14.Patients with prior hypersensitivity to monoclonal antibodies (mAb)
    15.Women who are pregnant or breastfeeding
    16.Patients who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents
    17.Patients with untreated or symptomatic central nervous system (CNS) metastases
    18.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.
    19. Prior known hypersensitivity reactions to study drugs and/or any of their excipients
    E.5 End points
    E.5.1Primary end point(s)
    •Objective response rate (ORR), which includes best response of complete response (CR) or partial response (PR) as assessed by the Investigator
    E.5.1.1Timepoint(s) of evaluation of this end point
    every 6 weeks from C1DC1 for the first 36 weeks and then 12 weeks thereafter.
    E.5.2Secondary end point(s)
    Key Secondary Endpoint
    •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

    Additional Secondary Endpoints
    •Treatment-emergent adverse events (TEAEs) and laboratory test results, physical examination or vital signs
    •CA-125 response determined using the GCIG criteria
    •Progression-free survival (PFS), defined as the time from first dose of mirvetuximab soravtansine until Investigator-assessed radiological PD or death, whichever occurs first
    •Overall survival (OS), defined as the time from first dose of mirvetuximab soravtansine until death
    E.5.2.1Timepoint(s) of evaluation of this end point
    Radiologic Tumor Assessments: every 6 weeks for the first 36 weeks and then every 12 weeks thereafter.
    TEAE: evaluated continually from the start of treatment
    Laboratory Tests, Physical Exam, Vital Signs: Day 1 of each cycle, end of treatment, and at 30-day follow-up
    CA-125: Prior to dosing on Day 1 of every cycle
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA61
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Israel
    United States
    France
    Poland
    Bulgaria
    Netherlands
    Spain
    Germany
    Italy
    Belgium
    Ireland
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    EOS will occur 12 months after the primary analysis for ORR. Patients still receiving clinical benefit from mirvetuximab soravtansine at EOS may continue to receive treatment either on this study or a long-term extension study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 110
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-11-16
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