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CA027-002: A Phase 1/2a Study of BMS-986253 in Combination With Nivolumab in Advanced Cancers

Studio Clinico

Patologia: Melanoma, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: I, II

Richiesta mandatoria di tessuto: 

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- Patients ≥ 18 years
- Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1
- At least 1 lesion accessible for biopsy
- Eastern Cooperative Oncology Group Performance Status of 0 or 1

Criteri di esclusione: 

- Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)
- Participants with active, known or suspected autoimmune disease
- Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
- Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)
- Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy

Other protocol defined inclusion/exclusion criteria could apply

Trattamento sperimentale: 

- Dose Finding: BMS-986253 administered in combination with Nivolumab
- Dose Expansion: BMS-986253 administered in combination with Nivolumab

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

- Incidence of adverse events (AE) [Time Frame: Approximately 5 years]
- Incidence of serious adverse events (SAE) [Time Frame: Approximately 5 years]
- Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria [Time Frame: Approximately 5 years]
- Incidence of AEs leading to discontinuation [Time Frame: Approximately 5 years]
- Incidence of deaths [Time Frame: Approximately 5 years]
- Incidence of labornatory abnormalities [Time Frame: Approximately 5 years]

Centri partecipanti

Nord Italia

Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI

Riferimento: Dr. Matteo Simonelli
Telefono: 0282244559
Email: matteo.simonelli@hunimed.eu

 

Sud Italia e isole

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

Riferimento: Dr. Paolo Ascierto
Telefono: 0815903236
Email: p.ascierto@istitutotumori.na.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT03400332

Data di inserimento: 07.03.2019

Promotore

Bristol-Myers Squibb

CRO

/

Principal Investigator ITALIA

Istituto Nazionale Tumori - IRCCS Fondazione Pascale, Napoli

Riferimento: Dr. Paolo Ascierto

Telefono: 0815903236

Email: p.ascierto@istitutotumori.na.it

Localita: Napoli

 

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