Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced So… (NCT03518606) | Clinical Trial Compass
CompletedPhase 1/2
Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours
France126 participantsStarted 2018-06-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient must have signed a written informed consent form prior to any study specific procedures.
✓. 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:
✓. Patients aged ≥18 years at registration.
✓. Life expectancy ≥3 months.
✓. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
✓. Body weight \>30 kg.
✓. Normal haematological function (ANC ≥1.5 x 10⁹/L; platelets count ≥100 x 10⁹/L; haemoglobin ≥9.0 g/dL).
Exclusion criteria
✕. Other concurrent malignancies, except adequately treated cone-biopsied in situ carcinoma of the cervix, or basal cell or squamous cell carcinoma of the skin. Patients who have had potentially curative therapy for a prior malignancy are eligible provided there has been no evidence of disease for ≥5 years and the risk of recurrence is considered low.
✕. Active brain metastases, spinal cord compression, or leptomeningeal disease. Patients whose brain metastases have been treated may participate if the brain metastases are stable by imagery (defined as 2 brain images, both obtained after treatment of the brain metastases and at least four weeks apart, and showing no evidence of intracranial progression). In addition, any neurologic symptoms caused by the brain metastases or their treatment must be resolved or stable, without steroidal treatment or with a dose of steroid ≤10 mg/day of prednisone or its equivalent and an anticonvulsants, for at least 14 days prior to the start of treatment.
What they're measuring
1
Maximum Tolerated Dose (MTD) and the phase II recommended dose (RP2D)
✕. Previous treatment with an anti-PD1/PD-L1 including durvalumab or an anti-CTLA-4 therapy including tremelimumab or vinorelbine.
✕. Patients with known allergy or severe hypersensitivity to any of the study treatments or any of the study treatment excipients.
✕. History of active primary immunodeficiency.
✕. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]). The following are exceptions to this criterion:
✕. History of allogeneic organ transplantation.
✕. History or evidence of active, non-infectious pneumonitis.