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

NCT05041257 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: IMGN853-04192021-003592-34
• Study Type: interventional
• Target: 79
• Locations: 7 countries
• Sites: 35

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) Assessed by Investigator Per 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 3 years

Secondary Outcomes (5)

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

  Up to 3 years

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

  Up to 3 years

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

  Up to 3 years

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

  Up to 3 years

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

  Up to 3 years

Study Arms (1)

Mirvetuximab Soravtansine

EXPERIMENTAL

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

Drug: Mirvetuximab soravtansine

Interventions

Mirvetuximab soravtansine DRUG

Administered by intravenous (IV) infusion on Day 1 of every 3-week cycle

Also known as: MIRV, IMGN853

Mirvetuximab Soravtansine

Eligibility Criteria

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

You may qualify if:

• Participants ≥ 18 years of age
• Participants must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
• 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-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
• Participants must have progressed radiographically on or after their most recent line of anticancer therapy
• Participants must have at least 1 lesion that meets the definition of measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (radiologically measured by the Investigator)
• 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 FRα positivity
• Participant's tumor must be positive for FRα expression as defined by the Ventana FOLR1 Assay
• Prior anticancer therapy
• Participants 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 - for example, 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: Participants who have had a documented platinum allergy may have had only 1 prior line of platinum
• Participants may have received up to but no more than 1 prior independent non-platinum cytotoxic therapy
• Participants 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 (for example, bevacizumab, PARP inhibitors) will be considered part of the preceding line of therapy (that is, not counted independently)
• Therapy changed due to toxicity in the absence of progression will be considered part of the same line (that is, not counted independently)

You may not qualify if:

• 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 prior wide-field radiotherapy (RT) affecting at least 20% 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
• 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)

Sponsors & Collaborators

• AbbVie: lead

Study Sites (35)

City of Hope National Medical Center /ID# 269928

Duarte, California, 91010, United States

Location

University of California Los Angeles /ID# 269969

Los Angeles, California, 90095-3075, United States

Location

University Colorado Cancer Center /ID# 269930

Aurora, Colorado, 80045-2517, United States

Location

Women'S Cancer Care /ID# 269925

Covington, Louisiana, 70433, United States

Location

Holy Name Medical Center /ID# 269927

Teaneck, New Jersey, 07666, United States

Location

Cleveland Clinic Main Campus /ID# 269922

Cleveland, Ohio, 44195, United States

Location

The Mark H Zangmeister Center /ID# 269929

Columbus, Ohio, 43219, United States

Location

Women & Infants Hospital /ID# 269923

Providence, Rhode Island, 02905, United States

Location

Duplicate_SCRI - Tennessee Oncology /ID# 269921

Nashville, Tennessee, 37203-1632, United States

Location

Texas Oncology - South Austin /ID# 269924

Austin, Texas, 78745, United States

Location

Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 269926

Norfolk, Virginia, 23502, United States

Location

Newcastle Private Hosptial /ID# 269734

Lambton Heights, New South Wales, 2305, Australia

Location

Monash Health - Monash Medical Centre /ID# 269735

Clayton, Victoria, 3168, Australia

Location

UZ Gent /ID# 269737

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Universitair Ziekenhuis Leuven /ID# 269736

Leuven, Vlaams-Brabant, 3000, Belgium

Location

UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 269738

Namur, 5000, Belgium

Location

Centre Armoricain de Radiotherapie Imagerie & Oncologie (CARIO) /ID# 269847

Plérin, Cotes-d Armor, 22190, France

Location

Institut de Cancérologie de l'Ouest René Gauducheau /ID# 269846

Saint-Herblain, Loire-Atlantique, 44805, France

Location

Centre Leon Berard /ID# 269848

Lyon, Rhone, 69373, France

Location

Institut de cancérologie Strasbourg Europe (ICANS) /ID# 269849

Strasbourg, 67200, France

Location

Bon Secours Cork Hospital /ID# 269851

Cork, T12 DV56, Ireland

Location

Waterford Regional Hospital /ID# 269852

Waterford, X91 ER8E, Ireland

Location

Istituto Nazionale Dei Tumori /ID# 269864

Milan, Milano, 20133, Italy

Location

Istituto Europeo Di Oncologia /ID# 269860

Milan, Milano, 20141, Italy

Location

Istituto Nazionale Tumori Irccs Fondazione G. Pascale /ID# 269863

Naples, Napoli, 80131, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 269861

Rome, Roma, 00168, Italy

Location

IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 269862

Bologna, 40138, Italy

Location

Hospital Universitario Reina Sofia /ID# 269892

Córdoba, Cordoba, 14004, Spain

Location

Hospital Universitario de Jaén /ID# 269895

Jaén, Jaen, 23007, Spain

Location

Hospital Universitario Vall d'Hebron /ID# 269889

Barcelona, 08035, Spain

Location

Hospital MD Anderson Cancer Center Madrid /ID# 269888

Madrid, 28033, Spain

Location

Hospital Universitario La Paz /ID# 269890

Madrid, 28046, Spain

Location

Hospital Universitario HM Sanchinarro /ID# 269891

Madrid, 28050, Spain

Location

Hospital Universitario Virgen del Rocio /ID# 269894

Seville, 41013, Spain

Location

Hospital Clínico Universitario de Valencia /ID# 269893

Valencia, 46010, Spain

Location

Related Publications (1)

• Alvarez Secord A, Lewin SN, Murphy CG, Cecere SC, Barquin A, Galvez-Montosa F, Mathews CA, Konecny GE, Ray-Coquard I, Oaknin A, Rubio Perez MJ, Bonaventura A, Diver EJ, Ayuk SM, Wang Y, Corr BR, Salutari V. The efficacy and safety of mirvetuximab soravtansine in FRalpha-positive, third-line and later, recurrent platinum-sensitive ovarian cancer: the single-arm phase II PICCOLO trial. Ann Oncol. 2025 Mar;36(3):321-330. doi: 10.1016/j.annonc.2024.11.011. Epub 2024 Nov 29.

  PMID: 39617145 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Neoplasms

Interventions

mirvetuximab soravtansine

Condition Hierarchy (Ancestors)

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: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 13, 2021
• Study Start: October 19, 2021
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: January 9, 2026
• Results First Posted: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3); US (11); IE (2); IT (5); ES (8); FR (4); AU (2)