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

Completed · Phase 2

Conditions studied: Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

In brief

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.

Key facts

Study ID

NCT05041257

Run by

AbbVie

People needed

79

Starts

2021-10-19

Expected to finish

2024-12-12

Last updated by the study team

2026-01-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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)
• 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)

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)
• 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

Where it is running

• City of Hope National Medical Center /ID# 269928 — Duarte, California, United States
• University of California Los Angeles /ID# 269969 — Los Angeles, California, United States
• University Colorado Cancer Center /ID# 269930 — Aurora, Colorado, United States
• Women'S Cancer Care /ID# 269925 — Covington, Louisiana, United States
• Holy Name Medical Center /ID# 269927 — Teaneck, New Jersey, United States
• Cleveland Clinic Main Campus /ID# 269922 — Cleveland, Ohio, United States
• The Mark H Zangmeister Center /ID# 269929 — Columbus, Ohio, United States
• Women & Infants Hospital /ID# 269923 — Providence, Rhode Island, United States
• Duplicate_SCRI - Tennessee Oncology /ID# 269921 — Nashville, Tennessee, United States
• Texas Oncology - South Austin /ID# 269924 — Austin, Texas, United States
• Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 269926 — Norfolk, Virginia, United States
• Newcastle Private Hosptial /ID# 269734 — Lambton Heights, New South Wales, Australia
• Monash Health - Monash Medical Centre /ID# 269735 — Clayton, Victoria, Australia
• UZ Gent /ID# 269737 — Ghent, Oost-Vlaanderen, Belgium
• Universitair Ziekenhuis Leuven /ID# 269736 — Leuven, Vlaams-Brabant, Belgium
• UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 269738 — Namur, Belgium
• Centre Armoricain de Radiotherapie Imagerie & Oncologie (CARIO) /ID# 269847 — Plérin, Cotes-d Armor, France
• Institut de Cancérologie de l'Ouest René Gauducheau /ID# 269846 — Saint-Herblain, Loire-Atlantique, France
• Centre Leon Berard /ID# 269848 — Lyon, Rhone, France
• Institut de cancérologie Strasbourg Europe (ICANS) /ID# 269849 — Strasbourg, France
• Bon Secours Cork Hospital /ID# 269851 — Cork, Ireland
• Waterford Regional Hospital /ID# 269852 — Waterford, Ireland
• Istituto Nazionale Dei Tumori /ID# 269864 — Milan, Milano, Italy
• Istituto Europeo Di Oncologia /ID# 269860 — Milan, Milano, Italy
• Istituto Nazionale Tumori Irccs Fondazione G. Pascale /ID# 269863 — Naples, Napoli, Italy

Full record on ClinicalTrials.gov

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