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Epithelial Ovarian CancerPhase 3SORAYANCT04296890

A 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 Phase 3 study testing Mirvetuximab Soravtansine in people with Epithelial Ovarian Cancer and Peritoneal Cancer, run by ImmunoGen, Inc. at 89 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is designed to evaluate the efficacy and safety of mirvetuximab soravtansine (MIRV) in participants with platinum-resistant high-grade serous epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of Folate Receptor-Alpha (FRα). Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Mirvetuximab Soravtansine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
89 sitesin 11 countries
Study dates
23 Jul 2020to 16 Nov 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female participants ≥ 18 years of age
  • Participants must have a confirmed diagnosis of high-grade serous epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer
  • Participants must have platinum-resistant disease:
  • Participants who have only had 1 line of platinum based therapy must have received at least 4 cycles of platinum, must have had a response (complete response/remission [CR] or partial response/remission [PR]) and then progressed between > 3 months and ≤ 6 months after the date of the last dose of platinum
  • Participants 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
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  • Note: Participants who are platinum refractory during front-line treatment are excluded (see exclusion criteria)
  • Participants must have progressed radiographically on or after their most recent line of anticancer therapy.
  • Participants 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 Folate Receptor α (FRα) positivity
  • Participant's tumor must be positive for FRα expression as defined by the Ventana FOLR1 Assay
  • Participants must have at least 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the Investigator)
  • Participants 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:
  • Adjuvant ± neoadjuvant considered 1 line of therapy
  • Maintenance therapy (e.g., bevacizumab, poly adenosine diphosphate-ribose polymerase (PARP) inhibitors) will be considered part of the preceding line of therapy (i.e., not counted independently)
  • Therapy changed due to toxicity in the absence of progression will be considered part of the same line (i.e., not counted independently)
  • Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance
  • Participants must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
  • Participants 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
  • Participants must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia)
  • Participants 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
  • Participants must have adequate hematologic, liver and kidney functions defined as:
  • 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
  • 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
  • Participants or their legally authorized representative 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

Who cannot join

  • Male participants
  • Participants with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumor
  • Participants 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
  • Participants with prior wide-field radiotherapy (RT) affecting at least 20 percent of the bone marrow
  • Participants with > Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE)
  • Participants 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
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  • Participants 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)
  • Human immunodeficiency virus (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
  • Participants with a history of multiple sclerosis (MS) or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
  • Participants 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
  • Participants with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment
  • Participants with a history of cirrhotic liver disease (Child-Pugh Class B or C)
  • Participants with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including noninfectious pneumonitis
  • Participants requiring use of folate-containing supplements (eg, folate deficiency)
  • Participants with prior hypersensitivity to monoclonal antibodies (mAb)
  • Women who are pregnant or breastfeeding
  • Participants who received prior treatment with MIRV or other FRα-targeting agents
  • Participants with untreated or symptomatic central nervous system (CNS) metastases
  • Participants with a history of other malignancy within 3 years prior to enrollment.
  • Note: Participants 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

Trial locations and contacts

89 sites in 11 countries.

89 sites in 11 countries

United States34 sites

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Texas Oncology-Austin Central

    Austin, Texas, 78731

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Women's Cancer Center

    Covington, Louisiana, 70433

  • City of Hope Medical Center

    Duarte, California, 91010

  • Texas Oncology, P.A. - Fort Worth Cancer Center

    Fort Worth, Texas, 76104

  • California Cancer Associates (cCARE)

    Fresno, California, 93720

  • Hinsdale Hospital

    Hinsdale, Illinois, 60521

  • St. Vincent Gynecologic Oncology

    Indianapolis, Indiana, 46260

  • Midwest Oncology Associates/Sarah Cannon

    Kansas City, Missouri, 64132

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

  • Rocky Mountain Cancer Centers

    Littleton, Colorado, 80120

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

  • Texas Oncology, P.A. - McAllen

    McAllen, Texas, 78503

  • Froedtert and the Medical College of Wisconsin Department of Obstetrics & Gynecology

    Milwaukee, Wisconsin, 53226

  • Sarah Cannon Research Institute / Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Mount Sinai Health System

    New York, New York, 10029

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Stanford School of Medicine

    Palo Alto, California, 94394

  • Arizona Oncology Associates

    Phoenix, Arizona, 85016

  • Center of Hope at Renown Medical Center

    Reno, Nevada, 89502

  • Maryland Oncology Hematology, P.A.

    Rockville, Maryland, 20850

  • California Pacific Medical Center Research Institute

    San Francisco, California, 94109

  • Sarasota Memorial Health Care System

    Sarasota, Florida, 34239

  • Texas Oncology, P.A. - Sugar Land

    Sugar Land, Texas, 77479

  • Florida Cancer Specialists Panhandle

    Tallahassee, Florida, 32308

  • University of South Florida

    Tampa, Florida, 33606

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

  • USOR: Texas Oncology - The Woodlands, Gynecologic Oncology

    The Woodlands, Texas, 77380

  • Texas Oncology, P.A. - Tyler

    Tyler, Texas, 75702

  • Florida Cancer Specialists Research

    West Palm Beach, Florida, 33401

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

Other trials in United States

Spain15 sites

  • Hospital Teresa Herrera - Complejo Hospitalario Universitario A Coruna

    A Coruña, Galicia, 15006

  • Institut Català d'Oncologia Badalona Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Quirón Dexeus

    Barcelona, 08028

  • Vall d'Hebron Institute of Oncology

    Barcelona, 08035

  • lnstitut Catala d' Oncologia L' Hospitalet

    Barcelona, 08908

  • Hospital Reina Sofia de Cordoba

    Córdoba, 14004

  • Institut Català d'Oncología de Girona

    Girona, 17007

  • Hospital La Paz

    Madrid, Castellana, 28046

  • Clinica Universidad de Navarra

    Madrid, 28027

  • MD Anderson Cancer Centre

    Madrid, 28033

  • Hospital Clínico Universitario San Carlos

    Madrid, 28040

  • Hospital Clinico Universitario Virgen de la Arrixaca

    Murcia, 30120

  • Corporació Sanitaria Parc Taulí

    Sabadell, 08208

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Instituto Valenciano de Oncologia

    Valencia, 46010

Other trials in Spain

Italy10 sites

  • Policlinico S. Orsola-Malpighi

    Bologna, 40138

  • Azienda Socio Santaria Territoriale degli Spedali Civili di Brescia

    Brescia, 25123

  • Istituto Oncologico Candiolo

    Candiolo, 10060

  • Ospedale Cannizzaro di Catania

    Catania, 95126

  • IEO Istituto Europeo di Oncologia

    Milan, 20141

  • Azienda Ospedaliera Ospedale Niguarda Ca'Granda

    Milan, 20162

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Naples, 80131

  • Istituto Nazionale Tumori- G. Pascale

    Naples, 87100

  • Ospedale S.Maria della Misericordia

    Perugia, 6129

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, 00168

Other trials in Italy

Israel7 sites

  • Rambam Medical Center

    Haifa, PO Box 9601

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Hadassah Ein Kerem Medical center

    Jerusalem, POB 12000

  • Meir Medical Center

    Kfar Saba, 4428164

  • Sheba Medical Center

    Ramat Gan, 5265601

  • Kaplan Medical Center

    Rehovot, 76100

  • Ziv Medical Center

    Safed, 13100

Other trials in Israel

Ireland6 sites

  • Cork University Hospital

    Cork, Munster, T12 DC4A

  • Bon Secours Hospital

    Cork, Munster, T12 DV56

  • Mater Misericordiae University Hospital

    Dublin, Leinster, 7

  • St. James's Hospital

    Dublin, Leinster, 8

  • Beaumont Hospital

    Dublin, 9

  • University Hospital Waterford

    Waterford, Munster, X91ER8E

Other trials in Ireland

Belgium5 sites

  • Cliniques Universitaires Saint Luc - lnstitut Roi Albert II

    Brussels, Brussels Capital, 1200

  • UZ Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • Centre Hopsitalier de l'Ardenne

    Libramont, Luxembourg, 6800

  • CHU UCL Namur/Site Sainte Elisabeth

    Namur, B5000

Other trials in Belgium

Australia4 sites

  • ICON Cancer Care

    Auchenflower, Queensland, 4066

  • Peninsula and South Eastern Haematology & Oncology Group

    Frankston, Victoria, 3199

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • St John of God Subiaco Hospital

    Subiaco, Western Australia, 6008

Other trials in Australia

Germany3 sites

  • KEM

    Essen, 45135

  • UMG Frauenklinik Robert-Koch-Str. 40

    Göttingen, Lower Saxony, 37075

  • Universitätsmedizin Mannheim

    Mannheim, Baden-Wurttemberg, 68167

Other trials in Germany

Poland3 sites

  • Specjalistyczna Przychodnia Lekarska Medicus

    Chorzów, Silesian Voivodeship, 41-500

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, Łódź Voivodeship, 93-338

  • Mazurskim Centrum Onkologiiw Olsztynie

    Olsztyn, Warmian-Masurian Voivodeship, 10-228

Other trials in Poland

Bulgaria1 site

  • MHAT "Serdika"

    Sofia, 1632

Other trials in Bulgaria

Czechia1 site

  • Všeobecná fakultní nemocnice v Praze

    Prague, Prague, 128 51

Other trials in Czechia

About this study

Official title: 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

This study is designed to evaluate the efficacy and safety of mirvetuximab soravtansine (MIRV) in participants with platinum-resistant high-grade serous epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of Folate Receptor-Alpha (FRα). Participants will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. All participants will receive single-agent MIRV at 6 mg/kg adjusted ideal body weight administered on Day 1 of every 3-week cycle.

Read the detailed description

This study is designed to evaluate the efficacy and safety of mirvetuximab soravtansine (MIRV) in participants with platinum-resistant high-grade serous epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of Folate Receptor Alpha (FRα). Participants will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. FRα positivity will be defined by the Ventana FOLR1 (Folate Receptor 1/Folate Receptor Alpha) Assay.

Approximately 110 eligible participants will be enrolled to achieve a total of 105 efficacy evaluable participants. Efficacy evaluable participants include those who have measurable lesions per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) at baseline and received at least 1 dose of MIRV.

All participants will receive single-agent MIRV at 6 mg/kg adjusted ideal body weight (AIBW) administered on Day 1 of every 3-week cycle (Q3W).

Tumor response will be evaluated by the Investigator using RECIST v1.1. Computerized tomography (CT) or magnetic resonance imaging (MRI) scans will be collected for sensitivity analysis by blinded independent central review (BICR).

Participants will continue to receive MIRV until disease progression, unacceptable toxicity, withdrawal of consent, death, or until the Sponsor terminates the study (whichever comes first).

Tumor assessments, including radiological assessments by CT/MRI scans will be performed at Screening and subsequently every 6 weeks (± 1 week) from Cycle 1 Day 1 (C1D1) for the first 36 weeks then every 12 weeks (± 3 weeks) until disease progression, death, the start of new anticancer therapy, or participant's withdrawal of consent (whichever occurs first).

Participants who discontinue MIRV for reasons other than progressive disease (PD) will continue with tumor assessments until documentation of PD or the start of a new anticancer therapy, whichever comes first. Prior to Week 36 (from Cycle 1, Day 1), assessments should occur every 6 weeks (± 1 week) as allowed by local requirements but must occur at an interval of no more than 12 weeks. After Week 36, assessment will occur every 12 weeks (± 3 weeks) until documentation of PD or the start of new anticancer therapy.

All participants who discontinue MIRV will be followed for survival every 3 months (± 1 month) until death, lost to follow-up, withdrawal of consent for survival follow-up, or end of study (EOS) (whichever comes first). Additional survival follow-up calls may occur periodically, if needed.

Being tested
Mirvetuximab Soravtansine
Keywords
Platinum resistant, Folate-receptor alpha expression, Phase 3, Antibody-drug conjugate, mirvetuximab soravtansine, IMGN853, Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer, MIRV, FRα
Medical subject headings
Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mirvetuximab SoravtansineDrug

    Also called IMGN853, MIRV

    Mirvetuximab Soravtansine is an antibody drug conjugate designed to target folate receptor α (FRα). It consists of the humanized anti-FRα mAb M9346A attached via a cleavable disulfide linker to the cytotoxic maytansinoid, DM4.

Study groups in NCT04296890
Study groupRoleWhat they receive
TreatmentExperimentalAll participants will receive single-agent mirvetuximab soravtansine (MIRV) at 6 mg/kg adjusted ideal body weight (AIBW) administered on Day 1 of every 3-week cycle (Q3W).
Receives: Drug: Mirvetuximab Soravtansine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    ORR was defined as percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm). PR: At least 30% decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.

    Measured: Up to approximately 15 months

Secondary outcomes (5)

  1. Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1

    DOR was defined as the time from the date of the first response (CR or PR), until the date of progressive disease (PD) or death from any cause, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. DOR was estimated using the Kaplan-Meier method.

    Measured: Up to approximately 15 months

  2. Percentage of Participants With CA-125 Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria

    The GCIG CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline. The response must have been confirmed and maintained for at least 28 days.

    Measured: Up to approximately 15 months

  3. Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1

    PFS was defined as the time from initiation of study drug until the date of PD or death whichever occurred first, estimated using the Kaplan-Meier method. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

    Measured: Up to approximately 15 months

  4. Overall Survival Assessed by the Investigator Using RECIST v1.1

    Overall survival was defined as the time from the date of first dose until the date of death from any cause, estimated using the Kaplan-Meier method.

    Measured: Up to approximately 27 months

  5. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to study drug. TEAEs were defined as AEs with an onset date on or after the first dose of Study drug, and within 30 days of the last dose of study drug or prior to the start of a new anticancer treatment, whichever occurred first. A summary of all Serious Adverse Events (SAEs) and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

    Measured: Up to approximately 27 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2020
  2. Study start23 Jul 2020
  3. Primary completion16 Nov 2021
  4. Study completion16 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All participants will receive single-agent MIRV at 6 mg/kg adjusted ideal body weight (AIBW) administered on Day 1 of every 3-week cycle (Q3W)
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04296890
Sponsor's protocol ID
IMGN853-0417
Other IDs
2020-000179-19
Acronym
SORAYA
Status last verified
Jul 2024
First submitted
27 Feb 2020
Last updated
7 Aug 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Coleman RL, Lorusso D, Oaknin A, Cecere SC, Denys H, Colombo N, van Gorp T, Konner JA, Romeo Marin M, Harter P, Murphy C, Wang Y, Esteves B, Method M, Matulonis U. Mirvetuximab soravtansine in folate receptor alpha (FRalpha)-high platinum-resistant ovarian cancer: final overall survival and post hoc sequence of therapy subgroup results from the SORAYA trial. Int J Gynecol Cancer. 2024 Aug 5;34(8):1119-1125. doi: 10.1136/ijgc-2024-005401.

    PubMed 38858103

  • Dilawari A, Shah M, Ison G, Gittleman H, Fiero MH, Shah A, Hamed SS, Qiu J, Yu J, Manheng W, Ricks TK, Pragani R, Arudchandran A, Patel P, Zaman S, Roy A, Kalavar S, Ghosh S, Pierce WF, Rahman NA, Tang S, Mixter BD, Kluetz PG, Pazdur R, Amiri-Kordestani L. FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRalpha-Positive, Platinum-Resistant Ovarian Cancer. Clin Cancer Res. 2023 Oct 2;29(19):3835-3840. doi: 10.1158/1078-0432.CCR-23-0991.

    PubMed 37212825

  • Matulonis UA, Lorusso D, Oaknin A, Pignata S, Dean A, Denys H, Colombo N, Van Gorp T, Konner JA, Marin MR, Harter P, Murphy CG, Wang J, Noble E, Esteves B, Method M, Coleman RL. Efficacy and Safety of Mirvetuximab Soravtansine in Patients With Platinum-Resistant Ovarian Cancer With High Folate Receptor Alpha Expression: Results From the SORAYA Study. J Clin Oncol. 2023 May 1;41(13):2436-2445. doi: 10.1200/JCO.22.01900. Epub 2023 Jan 30.

    PubMed 36716407

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mirvetuximab Soravtansine in people with Epithelial Ovarian Cancer and Peritoneal Cancer, run by ImmunoGen, Inc. at 89 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, Spain, Italy, Israel, Ireland and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (time frame: Up to approximately 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04296890, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.

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