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A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression (MIRASOL)

Studio Clinico

Patologia: Tumori dell’ovaio, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: 

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

• Female patients ≥ 18 years of age
• Patients must have a confirmed diagnosis of high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
• Patients must have platinum-resistant disease (defined as progression within 6 months from completion of a minimum of four cycles of platinum-containing therapy) Note: This should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression. Patients who are platinum-refractory during front-line treatment are excluded
• Patients must have progressed on or after their most recent line of therapy. Note: Progression must be determined radiographically and/or by CA-125 GCIG progression criteria
• 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 IHC confirmation of FRα positivity
• Patient's tumor must be positive for FRα expression as defined by the Ventana FOLR1 (FOLR-2.1) CDx assay
• Patients must have at least one lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the Investigator)
• Patients must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment:
- Adjuvant ± neoadjuvant considered one line of therapy
- Maintenance therapy (eg, bevacizumab, PARP inhibitors) will be considered as part of the preceding line of therapy (ie, not counted independently)
- Therapy changed due to toxicity in the absence of progression will be considered as part of the same line (ie, not counted independently)
- Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance
• Patient must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
• Time from prior therapy:
- Systemic antineoplastic therapy (5 half-lives or 4 weeks, whichever is shorter)
- Focal radiation completed at least 2 weeks prior to first dose of study drug
• Patients must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities
• Major surgery must be completed at least 4 weeks prior to first dose and have recovered or stabilized from the side effects of prior surgery
• Patients must have adequate hematologic, liver and kidney functions defined as:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1,500/μL)
- Platelet count ≥ 100 x 109/L (100,000/μL) without platelet transfusion in the prior 10 days
- Hemoglobin ≥ 9.0 g/dL
- 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 or their legally authorized representative 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) (as defined in Section 5.9.6 in the protocol) while on study drug and for at least 3 months after the last dose of MIRV or at least 6 months after the last dose of paclitaxel, pegylated liposomal doxorubicin, or topotecan
• WCBP must have a negative pregnancy test within 4 days prior to the first dose of study drug

Criteri di esclusione: 

• Patients with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade or borderline ovarian tumor
• Patients with primary platinum-refractory disease, defined as disease that did not respond to or has progressed within 3 months of the last dose of first line platinum-containing chemotherapy
• Patients with prior wide-field RT affecting at least 20% of the bone marrow
• Patients with > Grade 1 peripheral neuropathy per CTCAE v5.0
• 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
- Cytomegalovirus infection
- Any other concurrent infectious disease requiring IV antibiotics within 2 weeks before starting study drug
• Patients with history of multiple sclerosis or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
• Patients with clinically significant cardiac disease including, but not limited to, any one 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 assigned to PLD stratum only: Left ventricular ejection fraction (LVEF) below the institutional limit of normal as measured by echocardiography (ECHO) or multigated acquisition (MUGA) scan
• Patients with a history of hemorrhagic or ischemic stroke within six months prior to randomization
• Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)
• Patients with a previous clinical diagnosis of non-infectious interstitial lung disease (ILD), including noninfectious pneumonitis
• Patients with required use of folate-containing supplements (eg, folate deficiency)
• Patients with prior hypersensitivity to monoclonal antibodies
• Women who are pregnant or lactating
• Patients with 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 randomization. Note: does not include 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

Numero di pazienti previsti: 

430

Trattamento sperimentale: 

mirvetuximab soravtansine (MIRV; IMGN853)

MIRV 6 mg/kg adjusted ideal body weight (AIBW) every 3 weeks (Q3W)

Trattamento di controllo: 

Investigator's choice of chemotherapy

  • Paclitaxel (Pac; 80 mg/m2) administered once per week (QW) within a 4-week cycle
  • Pegylated liposomal doxorubicin (PLD; 40 mg/m2) administered every 4 weeks (Q4W)
  • Topotecan (Topo; 4 mg/m2) administered either on Days 1, 8, and 15 every 4 weeks or for 5 consecutive days (1.25 mg/m2 Days 1-5) every 3 weeks (Q3W)

Centri partecipanti

Nord Italia

ASST Spedali Civili di Brescia
Piazzale Spedali Civili 1 - 25123 Brescia - BS

 

ASST Lecco - PO Alessandro Manzoni
Via Dell'Eremo 9 - 23900 Lecco - LC

Riferimento: Dr. Antonio Ardizzoia
Telefono: 0341489900
Email: a.ardizzoia@asst-lecco.it

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI

Riferimento: Prof.ssa Nicoletta Colombo
Telefono: 0257489543
Email: nicoletta.colombo@ieo.it

 

Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD
Oncologia 2

Riferimento: Dr.ssa Giulia Tasca
Telefono: 0498215931
Email: giulia.tasca@iov.veneto.it

 

AUSL/IRCCS di Reggio Emilia
Viale Risorgimento 80 - 42123 Reggio nell'Emilia - RE

Riferimento: Dr.ssa Alessandra Bologna
Telefono: 0522296628
Email: alessandra.bologna@ausl.re.it

 

AO - Ordine Mauriziano
Largo Turati 62 - 10128 Torino - TO
SCDU Ostetricia e Ginecologia

Riferimento: Dr.ssa Annamaria Ferrero
Telefono: 0115082682
Email: annamaria.ferrero@unito.it

 

Centro Italia

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM

Riferimento: Prof.ssa Domenica Lorusso
Telefono: 0630158545
Email: domenica.lorusso@policlinicogemelli.it

 

Sud Italia e isole

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA

Riferimento: Dr. Sandro Pignata
Telefono: 0815903637
Email: s.pignata@istitutotumori.na.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2019-003509-80

Data di inserimento: 05.04.2022

Promotore

ImmunoGen, Inc.

Principal Investigator ITALIA

Istituto Europeo di Oncologia (IEO)

Riferimento: Prof.ssa Nicoletta Colombo

Telefono: 0257489543

Email: nicoletta.colombo@ieo.it

Localita: Milano

 

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