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Ovarian CancerPhase 2PICCOLONCT05041257

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

A Phase 2 study testing Mirvetuximab soravtansine in people with Ovarian Cancer and Peritoneal Cancer, run by AbbVie at 35 sites in 7 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

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Mirvetuximab soravtansine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
35 sitesin 7 countries
Study dates
19 Oct 2021to 12 Dec 2024
Phase
Phase 2
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

  • 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)
Show all 31Show fewer
  • 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)
  • 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 prior to first dose of MIRV
  • Participants must have adequate hematologic, liver and kidney functions defined as:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/liter (L) (1500/microliter [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
  • Platelet count ≥ 100 x 10^9/L (100,000/μL) without platelet transfusion in the prior 10 days
  • Hemoglobin ≥ 9.0 grams (g)/deciliter (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 (participants with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 x ULN)
  • Serum albumin ≥ 2 g/dL
  • Participants 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

  • 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)
Show all 28Show fewer
  • 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 (for example, 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 (for example, 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

35 sites in 7 countries.

35 sites in 7 countries

United States11 sites

  • University Colorado Cancer Center /ID# 269930

    Aurora, Colorado, 80045-2517

  • Texas Oncology - South Austin /ID# 269924

    Austin, Texas, 78745

  • Cleveland Clinic Main Campus /ID# 269922

    Cleveland, Ohio, 44195

  • The Mark H Zangmeister Center /ID# 269929

    Columbus, Ohio, 43219

  • Women'S Cancer Care /ID# 269925

    Covington, Louisiana, 70433

  • City of Hope National Medical Center /ID# 269928

    Duarte, California, 91010

  • University of California Los Angeles /ID# 269969

    Los Angeles, California, 90095-3075

  • Duplicate_SCRI - Tennessee Oncology /ID# 269921

    Nashville, Tennessee, 37203-1632

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

    Norfolk, Virginia, 23502

  • Women & Infants Hospital /ID# 269923

    Providence, Rhode Island, 02905

  • Holy Name Medical Center /ID# 269927

    Teaneck, New Jersey, 07666

Other trials in United States

Spain8 sites

  • Hospital Universitario Vall d'Hebron /ID# 269889

    Barcelona, 08035

  • Hospital Universitario Reina Sofia /ID# 269892

    Córdoba, Cordoba, 14004

  • Hospital Universitario de Jaén /ID# 269895

    Jaén, Jaen, 23007

  • Hospital MD Anderson Cancer Center Madrid /ID# 269888

    Madrid, 28033

  • Hospital Universitario La Paz /ID# 269890

    Madrid, 28046

  • Hospital Universitario HM Sanchinarro /ID# 269891

    Madrid, 28050

  • Hospital Universitario Virgen del Rocio /ID# 269894

    Seville, 41013

  • Hospital Clínico Universitario de Valencia /ID# 269893

    Valencia, 46010

Other trials in Spain

Italy5 sites

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

    Bologna, 40138

  • Istituto Nazionale Dei Tumori /ID# 269864

    Milan, Milano, 20133

  • Istituto Europeo Di Oncologia /ID# 269860

    Milan, Milano, 20141

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

    Naples, Napoli, 80131

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

    Rome, Roma, 00168

Other trials in Italy

France4 sites

  • Centre Leon Berard /ID# 269848

    Lyon, Rhone, 69373

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

    Plérin, Cotes-d Armor, 22190

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

    Saint-Herblain, Loire-Atlantique, 44805

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

    Strasbourg, 67200

Other trials in France

Belgium3 sites

  • UZ Gent /ID# 269737

    Ghent, Oost-Vlaanderen, 9000

  • Universitair Ziekenhuis Leuven /ID# 269736

    Leuven, Vlaams-Brabant, 3000

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

    Namur, 5000

Other trials in Belgium

Australia2 sites

  • Monash Health - Monash Medical Centre /ID# 269735

    Clayton, Victoria, 3168

  • Newcastle Private Hosptial /ID# 269734

    Lambton Heights, New South Wales, 2305

Other trials in Australia

Ireland2 sites

  • Bon Secours Cork Hospital /ID# 269851

    Cork, T12 DV56

  • Waterford Regional Hospital /ID# 269852

    Waterford, X91 ER8E

Other trials in Ireland

About this study

Official 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 (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.

Read the detailed description

Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called folate receptor alpha (FRα). It is being developed for the treatment of participants with recurrent platinum-sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression. Participants will have had at least 2 prior lines of therapy. These will include at least 2 lines of platinum-containing therapy or 1 line with a documented platinum allergy. FRα positivity will be defined by the Ventana FOLR1 (FOLR1- 2.1) CDx assay (Ventana FOLR1 Assay).

Being tested
Mirvetuximab soravtansine
Keywords
Platinum-sensitive, Ovarian cancer, Folate-receptor alpha expression, Antibody-drug conjugate, Cancer, Ovarian Neoplasma, Recurrent Platinum-Sensitive, High-Grade Ovarian, PICCOLO
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms, Neoplasms

What participants receive

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

  • Mirvetuximab soravtansineDrug

    Also called MIRV, IMGN853

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

Study groups in NCT05041257
Study groupRoleWhat they receive
Mirvetuximab SoravtansineExperimentalParticipants will receive MIRV 6.0 mg/kg adjusted by ideal body weight (AIBW)
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) 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.

    Measured: Up to 3 years

Secondary outcomes (5)

  1. Duration of Response (DOR) 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 3 years

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

    An adverse event (AE) was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and does not necessarily had 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 3 years

  3. 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 3 years

  4. 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 3 years

  5. 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 3 years

Timeline

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

  1. First posted13 Sep 2021
  2. Study start19 Oct 2021
  3. Primary completion12 Dec 2024
  4. Study completion12 Dec 2024

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05041257
Sponsor's protocol ID
IMGN853-0419
Other IDs
2021-003592-34
Acronym
PICCOLO
Status last verified
Dec 2025
First submitted
24 Aug 2021
Last updated
9 Jan 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39617145

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mirvetuximab soravtansine in people with Ovarian Cancer and Peritoneal Cancer, run by AbbVie at 35 sites in 7 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 31 inclusion and 28 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 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Spain, Italy, France, Belgium and 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 9 Jan 2026). 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) Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1]) (time frame: Up to 3 years). 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 NCT05041257, which also lists 1 linked publication.

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 9 Jan 2026.

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PICCOLO Clinical Trial NCT05041257 | AzTrials