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

NCT04296890 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: IMGN853-04172020-000179-19
• Study Type: interventional
• Target: 106
• Locations: 11 countries
• Sites: 89

Brief 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). 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.

Conditions

Epithelial Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer

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

Outcome Measures

Primary Outcomes (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.

  Up to approximately 15 months

Secondary Outcomes (5)

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

  Up to approximately 15 months

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

  Up to approximately 15 months

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

  Up to approximately 15 months

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

  Up to approximately 27 months

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

  Up to approximately 27 months

Study Arms (1)

Treatment

EXPERIMENTAL

All 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).

Drug: Mirvetuximab Soravtansine

Interventions

Mirvetuximab Soravtansine DRUG

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.

Also known as: IMGN853, MIRV

Treatment

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ImmunoGen, Inc.: lead

Study Sites (89)

Arizona Oncology Associates

Phoenix, Arizona, 85016, United States

Location

City of Hope Medical Center

Duarte, California, 91010, United States

Location

California Cancer Associates (cCARE)

Fresno, California, 93720, United States

Location

Stanford School of Medicine

Palo Alto, California, 94394, United States

Location

California Pacific Medical Center Research Institute

San Francisco, California, 94109, United States

Location

Rocky Mountain Cancer Centers

Littleton, Colorado, 80120, United States

Location

Sarasota Memorial Health Care System

Sarasota, Florida, 34239, United States

Location

Florida Cancer Specialists Panhandle

Tallahassee, Florida, 32308, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Florida Cancer Specialists Research

West Palm Beach, Florida, 33401, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Hinsdale Hospital

Hinsdale, Illinois, 60521, United States

Location

St. Vincent Gynecologic Oncology

Indianapolis, Indiana, 46260, United States

Location

University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

Location

Women's Cancer Center

Covington, Louisiana, 70433, United States

Location

Maryland Oncology Hematology, P.A.

Rockville, Maryland, 20850, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Midwest Oncology Associates/Sarah Cannon

Kansas City, Missouri, 64132, United States

Location

Center of Hope at Renown Medical Center

Reno, Nevada, 89502, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

Mount Sinai Health System

New York, New York, 10029, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Sarah Cannon Research Institute / Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

Texas Oncology-Austin Central

Austin, Texas, 78731, United States

Location

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

Fort Worth, Texas, 76104, United States

Location

Texas Oncology, P.A. - McAllen

McAllen, Texas, 78503, United States

Location

Texas Oncology, P.A. - Sugar Land

Sugar Land, Texas, 77479, United States

Location

USOR: Texas Oncology - The Woodlands, Gynecologic Oncology

The Woodlands, Texas, 77380, United States

Location

Texas Oncology, P.A. - Tyler

Tyler, Texas, 75702, United States

Location

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336, United States

Location

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

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

Milwaukee, Wisconsin, 53226, United States

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

ICON Cancer Care

Auchenflower, Queensland, 4066, Australia

Location

Peninsula and South Eastern Haematology & Oncology Group

Frankston, Victoria, 3199, Australia

Location

St John of God Subiaco Hospital

Subiaco, Western Australia, 6008, Australia

Location

Cliniques Universitaires Saint Luc - lnstitut Roi Albert II

Brussels, Brussels Capital, 1200, Belgium

Location

Centre Hopsitalier de l'Ardenne

Libramont, Luxembourg, 6800, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHU UCL Namur/Site Sainte Elisabeth

Namur, B5000, Belgium

Location

MHAT "Serdika"

Sofia, 1632, Bulgaria

Location

Všeobecná fakultní nemocnice v Praze

Prague, Prague, 128 51, Czechia

Location

Universitätsmedizin Mannheim

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

UMG Frauenklinik Robert-Koch-Str. 40

Göttingen, Lower Saxony, 37075, Germany

Location

KEM

Essen, 45135, Germany

Location

Mater Misericordiae University Hospital

Dublin, Leinster, 7, Ireland

Location

St. James's Hospital

Dublin, Leinster, 8, Ireland

Location

Cork University Hospital

Cork, Munster, T12 DC4A, Ireland

Location

Bon Secours Hospital

Cork, Munster, T12 DV56, Ireland

Location

University Hospital Waterford

Waterford, Munster, X91ER8E, Ireland

Location

Beaumont Hospital

Dublin, 9, Ireland

Location

Rambam Medical Center

Haifa, PO Box 9601, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Hadassah Ein Kerem Medical center

Jerusalem, POB 12000, Israel

Location

Meir Medical Center

Kfar Saba, 4428164, Israel

Location

Sheba Medical Center

Ramat Gan, 5265601, Israel

Location

Kaplan Medical Center

Rehovot, 76100, Israel

Location

Ziv Medical Center

Safed, 13100, Israel

Location

Policlinico S. Orsola-Malpighi

Bologna, 40138, Italy

Location

Azienda Socio Santaria Territoriale degli Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Istituto Oncologico Candiolo

Candiolo, 10060, Italy

Location

Ospedale Cannizzaro di Catania

Catania, 95126, Italy

Location

IEO Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

Azienda Ospedaliera Ospedale Niguarda Ca'Granda

Milan, 20162, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Napoli, 80131, Italy

Location

Istituto Nazionale Tumori- G. Pascale

Napoli, 87100, Italy

Location

Ospedale S.Maria della Misericordia

Perugia, 6129, Italy

Location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location

Specjalistyczna Przychodnia Lekarska Medicus

Chorzów, Silesian Voivodeship, 41-500, Poland

Location

Mazurskim Centrum Onkologiiw Olsztynie

Olsztyn, Warmian-Masurian Voivodeship, 10-228, Poland

Location

Instytut Centrum Zdrowia Matki Polki

Lodz, Łódź Voivodeship, 93-338, Poland

Location

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

Badalona, Barcelona, 08916, Spain

Location

Hospital La Paz

Madrid, Castellana, 28046, Spain

Location

Hospital Teresa Herrera - Complejo Hospitalario Universitario A Coruna

A Coruña, Galicia, 15006, Spain

Location

Hospital Quirón Dexeus

Barcelona, 08028, Spain

Location

Vall d'Hebron Institute of Oncology

Barcelona, 08035, Spain

Location

lnstitut Catala d' Oncologia L' Hospitalet

Barcelona, 08908, Spain

Location

Hospital Reina Sofia de Cordoba

Córdoba, 14004, Spain

Location

Institut Català d'Oncología de Girona

Girona, 17007, Spain

Location

Clinica Universidad de Navarra

Madrid, 28027, Spain

Location

MD Anderson Cancer Centre

Madrid, 28033, Spain

Location

Hospital Clínico Universitario San Carlos

Madrid, 28040, Spain

Location

Hospital Clinico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Corporació Sanitaria Parc Taulí

Sabadell, 08208, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Instituto Valenciano de Oncologia

Valencia, 46010, Spain

Location

Related Publications (3)

• 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.

  PMID: 38858103 DERIVED

• 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.

  PMID: 37212825 DERIVED

• 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.

  PMID: 36716407 DERIVED

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms

Interventions

mirvetuximab soravtansine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Results Point of Contact

• Title: CMO, ImmunoGen
• Organization: ImmunoGen, Inc

clinicaltrials@immunogen.com

781-895-0600

Study Officials

• Michael Method, MD, MPH, MBA

  ImmunoGen, Inc.

  STUDY DIRECTOR

• Ursula Matulonis, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

• Robert Coleman, MD

  The US Oncology Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 5, 2020
• Study Start: July 23, 2020
• Primary Completion: November 16, 2021
• Study Completion: November 16, 2022
• Last Updated: August 7, 2024
• Results First Posted: August 7, 2024

Record last verified: 2024-07

Locations

DE (3); AU (4); US (34); BE (5); IT (10); CZ (1); ES (15); IL (7); PL (3); IE (6); BU (1)