Open Actively Recruiting

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

About

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
Female
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Key Inclusion Criteria:

  • Patients ≥ 18 years of age
  • Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
  • Patients must have a confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer
  • Patients 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
  • Patients must have progressed radiographically on or after their most recent line of anticancer therapy
  • Patients must have at least 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the Investigator)
  • Patients 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
  • Patient's tumor must be positive for FRα expression as defined by the Ventana FOLR1 Assay
  • Prior anticancer therapy
    • Patients 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 - eg, 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: Patients who have had a documented platinum allergy may have had only 1 prior line of platinum
    • Patients may have received up to but no more than 1 prior independent non-platinum cytotoxic therapy
    • Patients 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 (eg, bevacizumab, PARP inhibitors) will be considered part of the preceding line of therapy (ie, not counted independently)
    • Therapy changed due to toxicity in the absence of progression will be considered part of the same line (ie, not counted independently)
  • Patients 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
  • Patients must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia)
  • Patients 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
  • Patients must have adequate hematologic, liver and kidney functions defined as:
    • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1500/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 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
  • Patients 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

Key Exclusion Criteria-

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

Join this Trial

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Study Stats
Protocol No.
21-001701
Category
Obstetrics & Gynecology
Oncology
Contact
Rachel Gray
Location
  • UCLA Beverly Hills
  • UCLA Westwood
For Providers
NCT No.
NCT05041257
For detailed technical eligibility, visit ClinicalTrials.gov.