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A phase 2 study to evaluate safety and anti-tumor activity of Avelumab in combination with Talazoparib in patients with BRCA or ATM mutant tumors - B9991032 (Javelin BRCA/ATM)

Studio Clinico

Patologia: Neoplasie della mammella, Tumori dell’ovaio, Carcinoma della prostata, Neoplasie cerebrali, Neoplasie dello stomaco, Epatocarcinoma, Carcinoma del pancreas esocrino, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Richiesta mandatoria di tessuto: 

Linee di trattamento: Non applicabile

Criteri di inclusione: 

- BRCA1, BRCA2 and/or ATM gene defect.
- Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumors that are not amenable for treatment with curative intent
- Availability a tumor tissue sample from a diagnostic biopsy/surgery or a metastatic tumor biopsy.
- Progressive disease at study enrollment.
- Minimum age 18 years (in Japan, minimum age 20 years).
- ECOG performance status 0 or 1.
- Adequate bone marrow, renal and liver function.
- For childbearing female patients, negative serum or urine pregnancy test at screening
- Signed and dated informed consent document.

Criteri di esclusione: 

- Prior anti-cancer therapy or radiation therapy within 2 weeks prior to enrolment. Palliative radiotherapy to metastatic lesion(s) permitted providing that it has been completed at least 2 days prior to enrolment and no significant toxicity are expected.
- Major surgery within 4 weeks prior to study enrollment.
- Current use of immunosuppressive medication at the time of study enrollment.
- Known prior severe hypersensitivity to investigational products or any component in their formulations
- Known history of immune-mediated colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis.
- Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
- Prior organ transplantation including allogenic stem-cell transplantation.
- Administration of live attenuated vaccines within 4 weeks of study enrollment.
- Diagnosis of myelodysplastic syndrome.
- Known symptomatic brain metastases requiring steroids.
- Persisting toxicity related to prior therapy Grade >1.
- Known history of HIV or AIDS.
- Positive HBV or HCV test indicating acute or chronic infection.
- Active infection requiring systemic therapy.
- Clinically significant (active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months prior to study enrollment; unstable angina, congestive heart failure or a serious cardiac arrhythmia requiring medication.
- Diagnosis of any other malignancy within 2 years prior to study enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast, bladder, or cervix, or low-grade prostate cancer or other early-stage low-risk cancers.
- Pregnant or breastfeeding female patients; female or male patients who are able to have children who are unable or unwilling to use contraception as outlined in the protocol.

Trattamento sperimentale: 

Avelumab+Talazoparib

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

Confirmed Objective Response (OR) [Time Frame: From date of first dose of study treatment until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to approximately 24 months]

Confirmed OR in patients with locally advanced or metastatic solid tumors with BRCA 1/2 or ATM defect, as assessed by Blinded Independent Central Review using RECIST v1.1 and, in patients with mCRPC, RECIST v1.1. and PCWG3.

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

 

IRCCS - IRST
Via P. Maroncelli 40 - 47014 Meldola - FC
Oncologia Medica

Riferimento: Dr. Giovanni Luca Frassineti
Telefono: 0543739271
Email: luca.frassineti@irst.emr.it

 

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI

Riferimento: Prof. Filippo De Braud
Telefono: 0223902148
Email: filippo.debraud@istitutotumori.mi.it

 

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

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

 

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

Riferimento: Dr. Marco Angelo Colleoni
Telefono: 0257489970
Email: marco.colleoni@ieo.it

 

A.O. San Gerardo
Via Pergolesi 33 - 20900 Monza - MB

Riferimento: Dr.ssa Marina Elena Cazzaniga

 

Centro Italia

Ospedale Riuniti Umberto I - Lancisi-Salesi
Via Conca 71 - 60020 Ancona - AN

Riferimento: Prof.ssa Rossana Berardi
Telefono: 0715965715
Email: r.berardi@univpm.it

 

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

Riferimento: Prof. Giovanni Scambia
Email: giovanni.scambia@policlinicogemelli.it

 

Università La Sapienza Policlinico Umberto I
Viale del Policlinico 155 - 00161 Roma - RM

Riferimento: Prof. Enrico Cortesi
Telefono: 064462982
Email: dhoncologico.cortesi@uniroma1.it

 

Sud Italia e isole

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

Riferimento: Dr. Sandro Pignata
Telefono: 0815903409
Email: s.pignata@istitutotumori.na.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2018-000345-39

Data di inserimento: 23.01.2019

Promotore

Pfizer

CRO

/

Principal Investigator ITALIA

Istituto Europeo di Oncologia, Milano

Riferimento: Prof.ssa Nicoletta Colombo

Telefono: 0257489543

Email: nicoletta.colombo@ieo.it

Localita: Milano

 

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