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A phase 2, open label study to evaluate safety and clinical activity of Avelumab (Bavencio (registered)) in combination with Axitinib ((nlyta (registered)) in patients with advanced or metastatic previously treated non-small cell lung cancer or treatment naïve cisplatin-ineligible urothelial cancer (Javelin Medley VEGF) - B9991027

Studio Clinico

Patologia: Carcinoma della vescica, Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Richiesta mandatoria di tessuto: 

Linee di trattamento: Prima linea, Seconda linea

Criteri di inclusione: 

- Non-small cell lung cancer (NSCLC) Cohort: Histologically or cytologically confirmed diagnosis of NSCLC that is locally advanced or metastatic; No activating EGFR mutations, ALK or ROS1 translocations/rearrangements where testing is standard of care; received at least 1 prior platinum‑based chemotherapy regimen for locally advanced or metastatic NSCLC; No more than 2 prior lines of systemic therapy for locally advanced or metastatic disease (If disease progression occurred during or within 6 months after neoadjuvant/adjuvant chemotherapy or radiotherapy‑chemotherapy, the regimen is counted as 1 prior treatment regimen towards the allowed limit of prior treatment regimens); Checkpoint inhibitor naïve.
- Urothelial Cancer (UC) Cohort: Histologically or cytologically confirmed diagnosis of transitional cell carcinoma (TCC) of the urothelium (if mixed, more than 50% TCC component) including bladder, urethra, ureters, or renal pelvis that is locally advanced or metastatic; No prior systemic treatment for locally advanced or metastatic disease; Prior neoadjuvant or adjuvant therapy is permitted if disease progression occurred >12 months after the completion of therapy; Checkpoint inhibitor naïve; Ineligible for receiving cisplatin‑containing front‑line chemotherapy based at least one of the following criteria: ECOG performance status (PS) 2; Renal dysfunction (defined as creatinine‑clearance <60 ml/min); Grade 2 peripheral neuropathy; Grade 2 hearing loss (hearing loss measured by audiometry of 25 decibels at two contiguous frequencies).
- At least 1 measurable lesion by RECIST v1.1 not previously irradiated.
- Availability of an archival FFPE tumor tissue block from primary diagnosis specimen or metastatic specimen or 15 unstained slides (10 minimum). If an archived sample is not available, a fresh tumor biopsy must be performed.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. For UC patients, ECOG performance 2 is permitted (cisplatin ineligibility criterion)

Criteri di esclusione: 

- Prior immunotherapy with an anti‑PD‑1, anti‑PD‑L1, anti‑PD‑L2, anti‑CD137, anti‑OX‑40, anti‑GITR, anti‑LAG‑3, anti‑TIM‑3 or anti‑CTLA‑4 antibody (including ipilimumab).
- Newly diagnosed brain metastases or known symptomatic brain metastases requiring steroids.
- Radiologically documented evidence of major blood vessel invasion or encasement by cancer or intratumor cavitation, regardless of tumor histology.
- Active autoimmune disease (that might deteriorate when receiving an immunostimulatory agent).
- Current use of immunosuppressive medication (except for those listed in protocol).
- Known prior severe hypersensitivity to the investigational products /monoclonal antibodies.
- Known history of immune‑mediated colitis, inflammatory bowel disease, immune‑mediated pneumonitis, pulmonary fibrosis.
- NCI CTCAE Grade 3 hemorrhage within 28 days prior to study enrollment

Schema di trattamento: 

Avelumab administered at 800 mg IV every two weeks in combination with axitinib, 5 mg PO BID

Trattamento sperimentale: 

Avelumab+Axitinib

Trattamento di controllo: 

/

Obiettivi primari dello studio: 

Confirmed objective response [Time Frame: Baseline up to approximately 18 months]

Objective response (OR) is defined as a confirmed complete response (CR) or partial (PR) per RECIST v 1.1

Centri partecipanti

Nord Italia

Azienda Ospedaliero-Universitaria di Parma
Via Gramsci 14 - 43126 Parma - PR
U.O. Oncologia Medica

Riferimento: Dr. Marcello Tiseo
Email: mtiseo@ao.pr.it

 

Centro Italia

Azienda Ospedaliera di Perugia
Via Dottori 1 - 06132 Perugia - PG

Riferimento: Dr. Fausto Roila
Telefono: 0755784211
Email: roila.fausto@libero.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

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2017-004345-24

Data di inserimento: 23.01.2019

Promotore

Pfizer

CRO

/

Principal Investigator ITALIA

Azienda Ospedaliera Universitaria Policlinico Umberto I, Roma

Riferimento: Prof. Enrico Cortesi

Telefono: 064462982

Email: dhoncologico.cortesi@uniroma1.it

Localita: Roma

 

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