Spots Global Cancer Trial Database for Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours

Official Title: A Phase I/II Basket Trial Evaluating a Combination of Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumour

Study ID: NCT03518606

Conditions

Advanced Solid Tumours

Interventions

Durvalumab + Tremelimumab + metronomic Vinorelbine

Study Description

Brief Summary: This is a phase I/II national, multicentre, multiple cohort, prospective open-label, non-randomised and non-comparative study, to evaluate the safety and activity of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy for the treatment of advanced solid tumours.

Detailed Description: Methodology: The study divided in two parts: * Phase I part: dose escalation study of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy, * Phase II part: activity study of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy. Indication: Patient eligible to the study are patients with histologically confirmed locally advanced or metastatic solid tumours, resistant to conventional therapies, and candidate to experimental therapy by local clinical board, from the following primary tumours: head and neck, prostate, cervix, and breast cancers, as well as miscellaneous malignancies with high mutational load.