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A randomized, open-label, multicenter, phase 3 study to evaluate the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of avelumab in combination with the poly (adenosine diphosphate [adp]-ribose) polymerase (parp) inhibitor talazoparib in patients with previously untreated advanced ovarian cancer (JAVELIN OVARIAN PARP 100) - B9991030

Studio Clinico

Patologia: Tumori dell’ovaio

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: 

Linee di trattamento: Prima linea

Criteri di inclusione: 

- Histologically confirmed Stage III IV epithelial ovarian, fallopian tube, or primary peritoneal cancer including carcinosarcoma with high-grade serous component.
- Patients must be candidates for bevacizumab in combination with platinum based chemotherapy and previously untreated.
- Must have completed a primary surgical debulking procedure, or be candidates for neoadjuvant chemotherapy with planned interval debulking surgery.
    1. Patients who completed primary debulking must have had incompletely resected disease that is macroscopically/grossly visible and at least with lesions >1 mm and be randomized at a maximum of 8 weeks after surgery.

    2. For patients who are candidates for neoadjuvant chemotherapy, the diagnoses must have been confirmed by:
        - Core tissue (not fine-needle aspiration) biopsy is required for diagnosis.
        - Stage IIIC-IV documented via imaging or surgery (without attempt at cytoreduction).
        - Serum CA-125/CEA ratio >25. If the serum CA-125/CEA ratio is <25, then workup should be negative for the presence of a primary gastrointestinal or breast malignancy (<6 weeks before start of neoadjuvant treatment).
        - Randomization must occur within 8 weeks after diagnosis.

- Availability of an archival FFPE tumor tissue block or a minimum of 25 slides, together with an accompanying original H&E slide. If archived FFPE tissue is not available, a de novo (ie, fresh) tumor sample must be obtained in accordance with local institutional practice for tumor biopsies. Tumor tissue must contain 40% or greater tumor nuclei per central laboratory assessment.- ECOG performance status 0-1
- Age >=18 years.
- Adequate bone marrow, hepatic, and renal function and blood coagulation

Criteri di esclusione: 

- Non-epithelial tumors or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors.
- Patients for whom intraperitoneal cytotoxic chemotherapy is planned.
- Prior exposure to immunotherapy with interleukin (IL)-2, interferon alpha (IFN-α), or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte associated antigen 4 (anti-CTLA4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, excluding therapeutic anticancer vaccines.
- Prior treatment with a PARP inhibitor.
- Prior treatment with any anti-vascular endothelial growth factor (VEGF) drug, including bevacizumab.
- Major surgery (other than debulking or exploratory surgery for ovarian cancer) for any reason within 4 weeks prior to randomization and/or incomplete recovery from surgery.
- Prior radiotherapy to any portion of the abdominal cavity or pelvis. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
- Prior targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their ovarian, peritoneal primary or fallopian tube carcinoma.
- Prior organ transplantation including allogenic stem cell transplantation.
- Diagnosis of Myelodysplastic Syndrome (MDS).
- Known symptomatic brain metastases requiring steroids. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study enrollment, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable.

Trattamento sperimentale: 

Platinum-based chemotherapy + avelumab followed by avelumab + talazoparib maintenance

Trattamento di controllo: 

Platinum-based chemotherapy + bevacizumab followed by bevacizumab maintenance

Obiettivi primari dello studio: 

Progression-Free Survival (PFS) [Time Frame: Baseline to measured progressive disease (up to approximately 41 months)]

The time from the date of randomization to the date of the first documentation of Progression of Disease or death due to any cause, whichever occurs first. Assessments to be completed by third-party blinded independent committee review.

Centri partecipanti

Nord Italia

Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO

Riferimento: Dr. Claudio Zamagni
Telefono: 0512144548
Email: claudio.zamagni@aosp.bo.it

 

E.O. OSPEDALI GALLIERA - GENOVA
Via Mura delle Cappuccine 14 - 16128 Genova - GE
S.C. Oncologia Medica

Riferimento: Prof. Andrea De Censi
Telefono: 0105634501
Email: andrea.decensi@galliera.it

 

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: Dr.ssa Gabriella Maria Parma
Telefono: 0257489543
Email: gabriella.parma@ieo.it

 

A.O.U. Policlinico di Modena
Via del Pozzo 71 - 41100 Modena - MO

Riferimento: Dr. Roberto Sabbatini

 

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

Riferimento: Prof. PierFranco Conte
Telefono: 0498215290
Email: pierfranco.conte@unipd.it

 

AO della Valtellina e Valchiavenna
Via Stelvio 25 - 23100 Sondrio - SO
P.O. di Sondrio

Riferimento: Dr. Alessandro Stefano Bertolini
Telefono: 0342521167
Email: alessandro.bertolini@aovv.it

 

IRCCS Candiolo (TO)
St.Provinciale Km 3,95 SP142 - 10060 Candiolo - TO

Riferimento: Dr. Giorgio Valabrega
Telefono: 0119933250
Email: giorgio.valabrega@ircc.it

 

Centro Italia

Nuovo Ospedale di Prato
Via Suor Niccolina Infermiera 20 - 59100 Prato - PO
Oncologia

Riferimento: Dr.ssa Elena Zafarana

 

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

Riferimento: Prof. Giovanni Scambia

 

Sud Italia e isole

A.O. per l’Emergenza Cannizzaro di Catania
Via Messina 829 - 95126 Catania - CT
Oncologia Medica

Riferimento: Dr.ssa Giuseppa Scandurra
Email: oncologiacatania@yahoo.com

 

AOU degli studi della Campania Luigi Vanvitelli
Piazza Luigi Miraglia 2 - 80138 Napoli - NA

Riferimento: Prof. Michele Orditura
Telefono: 0815666713
Email: michele.orditura@unicampania.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2017‐004456‐30

Data di inserimento: 22.01.2019

Promotore

Pfizer

CRO

/

Principal Investigator ITALIA

Riferimento: Dr.ssa Gabriella Maria Parma

Telefono: 0257489543

Email: gabriella.parma@ieo.it

Localita: Milano

 

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