Etude : MIRASOL /



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Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : MIRASOL

Situation thérapeutique :

Traitement : Chimiothérapie / Immunothérapie / Thérapie ciblée

Cadre réglementaire : RIPH1

Dernière MÀJ : 30/11/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Étude de phase III randomisée, en ouvert, évaluant le mirvétuximab soravtansine par rapport à la chimiothérapie choisie par l’investigateur dans le cancer avancé épithélial de haut grade de l’ovaire, péritonéal primitif ou des trompes de Fallope, résistant au platine, présentant une expression élevée des récepteurs alpha des folates

Spécialité : Seins, organes génitaux de la femme
Localisation : C56 - Tumeur maligne de l'ovaire

Spécialité : Seins, organes génitaux de la femme
Localisation : C57 - Tumeur maligne des organes génitaux de la femme, autres et non précisés
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine vs. investigator's choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. Folate receptor alpha (FRα) positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.

Study Arms:

- Experimental: mirvetuximab soravtansine (MIRV; IMGN853)
MIRV 6 mg/kg adjusted ideal body weight (AIBW) every 3 weeks (Q3W)
Intervention: Drug: Mirvetuximab Soravtansine

- Active Comparator: 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)

Phase : III

Stade : Localisé à Métastatique

2, 3, 4
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion :
1. Female patients ≥ 18 years of age
2. Patients must have a confirmed diagnosis of high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube can
3. Patients must have platinum-resistant disease (defined as prog months from completion of a minimum of four cycles of platinum therapy) Note: This should be calculated from the date of the la dose of platinum therapy to the date of the radiographic imagin progression. Patients who are platinum-refractory during frontare excluded
4. Patients must have progressed on or after their most recent lin
Note: Progression must be determined radiographically and/or GCIG progression criteria
5. Patients must be willing to provide an archival tumor tissue blo undergo procedure to obtain a new biopsy using a low risk, me procedure for IHC confirmation of FRα positivity
6. Patient's tumor must be positive for FRα expression as defined FOLR1 (FOLR-2.1) CDx assay
7. Patients must have at least one lesion that meets the definition disease by RECIST v1.1 (radiologically measured by the Inves
8. Patients must have received at least 1 but no more than 3 prio of anticancer therapy, and for whom single-agent therapy is ap next line of treatment:
a. Adjuvant ± neoadjuvant considered one line of therapy
b. Maintenance therapy (eg, bevacizumab, PARP inhibitors considered as part of the preceding line of therapy (ie, no independently)
c. Therapy changed due to toxicity in the absence of progre considered as part of the same line (ie, not counted inde
d. Hormonal therapy will be counted as a separate line of th was given as maintenance
9. Patient must have an Eastern Cooperative Oncology Group Pe Status (ECOG PS) of 0 or 1
10. Time from prior therapy:
a. Systemic antineoplastic therapy (5 half-lives or 4 weeks shorter)
b. Focal radiation completed at least 2 weeks prior to first drug
11. Patients must have stabilized or recovered (Grade 1 or baseline) from therapy-related toxicities
12. Major surgery must be completed at least 4 weeks prior to first dose and recovered or stabilized from the side effects of prior surgery
13. Patients must have adequate hematologic, liver and kidney functions defined
as:
a. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1,500/μL)
b. Platelet count ≥ 100 x 109/L (100,000/μL) without platelet transfusion the prior 10 days
c. Hemoglobin ≥ 9.0 g/dL
d. Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
e. Aspartate aminotransferase (AST) and alanine aminotransferase 3.0 x ULN
f. Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis Gilbert syndrome are eligible if total bilirubin < 3.0 x ULN
g. Serum albumin ≥ 2 g/dL
14. Patients or their legally authorized representative must be willing and sign the informed consent form (ICF) and to adhere to the protocol requirements
15. 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 study drug and for at least 3 months after the last dose of MIRV or at least months after the last dose of paclitaxel, pegylated liposomal doxorubicin, topotecan
16. WCBP must have a negative pregnancy test within 4 days prior to the of study drug

Critères de non-inclusion : 1. Patients with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade or borderline ovarian tumor
2. Patients with primary platinum-refractory disease, defined as disease not respond to or has progressed within 3 months of the last dose of first platinum-containing chemotherapy
3. Patients with prior wide-field RT affecting at least 20% of the bone
4. Patients with > Grade 1 peripheral neuropathy per CTCAE v5.0
5. 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 degeneration requiring intravitreal injections, active diabetic retinopathy macular edema, macular degeneration, presence of papilledema, and monocular vision
6. Patients with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:
a. Active hepatitis B or C infection (whether or not on active antiviral therapy)
b. HIV infection
c. Cytomegalovirus infection
d. Any other concurrent infectious disease requiring IV antibiotics within weeks before starting study drug
7. Patients with history of multiple sclerosis or other demyelinating disease Lambert-Eaton syndrome (paraneoplastic syndrome)
8. Patients with clinically significant cardiac disease including, but not limited any one of the following:
a. Myocardial infarction ≤ 6 months prior to first dose
b. Unstable angina pectoris
c. Uncontrolled congestive heart failure (New York Heart Association class II)
d. Uncontrolled ≥ Grade 3 hypertension (per CTCAE)
e. Uncontrolled cardiac arrhythmias
9. Patients assigned to PLD stratum only: Left ventricular ejection fraction below the institutional limit of normal as measured by echocardiography
(ECHO) or multigated acquisition (MUGA) scan
10. Patients with a history of hemorrhagic or ischemic stroke within six months prior to randomization
11. Patients with a history of cirrhotic liver disease (Child-Pugh Class B or 12. Patients with a previous clinical diagnosis of non-infectious interstitial disease (ILD), including noninfectious pneumonitis
13. Patients with required use of folate-containing supplements (eg, folate deficiency)
14. Patients with prior hypersensitivity to monoclonal antibodies
15. Women who are pregnant or lactating
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04209855
Promoteur :
ImmunoGen, Inc.
Type de sponsor : Industriel
-
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Oscar Lambret - 3 Rue Frédéric Combemale - 59000 LILLE

Investigateur :
Docteur Stéphanie BECOURT

TEC / ARC / IDE :
Unité Intégrée de Recherche Clinique
investigation@
o-lambret.fr
03.20.29.59.35

Statut de l'essai : OUVERT

MAJ : 15/01/2021