Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours
NCT03518606 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 126
Last updated 2025-01-15
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.
Conditions
- Advanced Solid Tumours
- Breast Cancer
- Head and Neck Cancer
- Cervix Cancer
- Prostate Cancer
Interventions
- DRUG
-
Durvalumab + Tremelimumab + metronomic Vinorelbine
Patient will be treated by metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy
Sponsors & Collaborators
-
National Cancer Institute, France
collaborator OTHER_GOV - collaborator INDUSTRY
-
Pierre Fabre Laboratories
collaborator INDUSTRY -
UNICANCER
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-06-20
- Primary Completion
- 2022-04-01
- Completion
- 2024-12-19
Countries
- France
Study Locations
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