Avelumab Plus Intermittent Axitinib in Previously Untreated Patients With Metastatic Renal Cell Carcinoma

PHASE2UnknownINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

October 7, 2020

Primary Completion Date

September 30, 2023

Study Completion Date

October 31, 2024

Conditions
Renal Carcinoma Metastatic
Interventions
DRUG

Axitinib Oral Tablet

"Axitinib is an orally bioavailable tyrosine kinase inhibitor currently approved in EU for treatment of patients affected by metastatic renal cell carcinoma (mRCC) progressed after another anti VEGFR-tyrosine kinase inhibitor (TKI).~Axitinib inhibits the proangiogenic cytokines vascular endothelial growth factor (VEGF) and platelet-derived growth factor receptor (PDGF), thereby exerting an anti-angiogenic effect."

DRUG

Avelumab

Avelumab is a human immunoglobulin G1 (IgG1) monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein, with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, avelumab binds to PD-L1 and prevents the interaction of PD-L1 with its receptor programmed cell death protein 1 (PD-1). This inhibits the activation of PD-1 and its downstream signaling pathways. This may restore immune function through the activation of cytotoxic T lymphocytes (CTLs) targeted to PD-L1-overexpressing tumor cells. In addition, avelumab induces an antibody-dependent cellular cytotoxic (ADCC) response against PD-L1-expressing tumor cells. PD-1, a cell surface receptor belonging to the immunoglobulin superfamily expressed on T cells, negatively regulates T-cell activation and effector function when activated by its ligand, and plays an important role in tumor evasion from host immunity.

Trial Locations (20)

Unknown

ACTIVE_NOT_RECRUITING

Azienda Ospedaliera Universitaria di Cagliari- P.O. Duilio Casula Monserrato, Monserrato

NOT_YET_RECRUITING

ASL CN2 Alba-Bra, Alba

NOT_YET_RECRUITING

Irccs Oncologico Istituto Tumori Giovanni Paolo Ii, Bari

NOT_YET_RECRUITING

ASST Papa Giovanni XXIII, Bergamo

NOT_YET_RECRUITING

Azienda Ospedaliero-Universitaria Di Bologna Suor Orsola Malpighi, Bologna

NOT_YET_RECRUITING

Ospedale Policlinico San Martino, Genova

NOT_YET_RECRUITING

"OSPEDALE di LECCE VITO FAZZI", Lecce

NOT_YET_RECRUITING

Presidio Ospedaliero Unico Av3 - Ospedale Generale Provinciale - Macerata, Macerata

RECRUITING

Istituto Clinico Humanitas, Milan

NOT_YET_RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

NOT_YET_RECRUITING

Azienda Ospedaliero-Universitaria di Modena, Modena

NOT_YET_RECRUITING

Istituto Oncologico Veneto, Padua

RECRUITING

Azienda Ospedaliero-Universitaria di Parma, Parma

NOT_YET_RECRUITING

Istituti Clinici Scientifici Maugeri, Pavia

ACTIVE_NOT_RECRUITING

Irccs Istituto in Tecnologie Avanzate E Modelli Assistenziali in Oncologia Di Reggio Emilia, Reggio Emilia

NOT_YET_RECRUITING

Azienda Ospedaliera San Camillo-Forlanini, Roma

RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome

NOT_YET_RECRUITING

Azienda Ospedaliera Santa Maria Terni, Terni

ACTIVE_NOT_RECRUITING

Azienda Ospedaliero-Universitaria S. Luigi Gonzaga, Torino

ACTIVE_NOT_RECRUITING

Azienda Ospedaliero-Universitaria Integrata Verona - Borgo Roma, Verona

Sponsors
All Listed Sponsors
collaborator

Clinical Research Technology S.r.l.

INDUSTRY

lead

Consorzio Oncotech

OTHER

NCT04698213 - Avelumab Plus Intermittent Axitinib in Previously Untreated Patients With Metastatic Renal Cell Carcinoma | Biotech Hunter | Biotech Hunter