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

Sponsor
UNICANCER
Study ID
NCT03518606
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 20, 2018
Status verified
Jan 2024
Primary completion
Apr 1, 2022
Completion
Dec 19, 2024

Study Design

Enrollment
126 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Breast cancer cohort
    Patients presenting advanced refractory breast cancer
  • Experimental: Head and neck cohort
    Patients presenting advanced refractory head and neck cancer
  • Experimental: Cervix cohort
    Patients presenting advanced refractory cervix cancer
  • Experimental: Prostate cohort
    Patients presenting advanced refractory prostate cancer
  • Experimental: Miscellaneous cohort
    Patients presenting advanced refractory solid tumour with high mutational load

Primary Outcome Measure

Maximum Tolerated Dose (MTD) and the phase II recommended dose (RP2D) [ Time Frame: 9 months ]

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