NCT03518606

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumours
• Breast Cancer
• Head and Neck Cancer
• Cervix Cancer
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab + Tremelimumab + metronomic Vinorelbine	Patient will be treated by metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy

Timeline

• Start date: 2018-06-20
• Primary completion: 2022-04-01
• Completion: 2024-12-19
• First posted: 2018-05-08
• Last updated: 2025-01-15

Locations

9 sites across 1 country: France