Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian Tube Cancers (PICCOLO)
a study on Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer
Summary
- Eligibility
- for females ages 18 years and up (full criteria)
- Location
- at Los Angeles, California and other locations
- Dates
- study startedcompletion around
- Principal Investigator
- by Gottfried Konecny
Description
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.
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)
Details
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 subjects with recurrent platinum-sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression. Patients 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)
Keywords
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer, Platinum-sensitive, Folate-receptor alpha expression, Antibody-drug conjugate, Cancer, Ovarian Neoplasma, Recurrent Platinum-Sensitive,, High-Grade Ovarian, PICCOLO, Ovarian Neoplasms, Fallopian Tube Neoplasms, Hypersensitivity, Maytansine, Mirvetuximab soravtansine
Eligibility
You can join if…
Open to females ages 18 years and up
- 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 109/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 109/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
You CAN'T join if...
-
- 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
Locations
- UCLA-JCCC Dept of OBGYN - Women's Health Clinical Research Unit
Los Angeles California 90095 United States - City of Hope
Duarte California 91010 United States
Lead Scientist at UCLA
Details
- Status
- in progress, not accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- ImmunoGen, Inc.
- ID
- NCT05041257
- Phase
- Phase 2 research study
- Study Type
- Interventional
- Participants
- About 79 people participating
- Last Updated