Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
Inclusion Criteria:1. Patient must have signed a written informed consent form prior to any study specific procedures. 2. 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 squamous cell carcinomas, - Breast cancer, - Prostate cancer, - Cervical cancer, - Miscellaneous primary tumours (except melanoma, non-small cell lung cancer [NSCLC], and renal cell cancer) with a high mutational load, as defined by a molecular clinical board after next-generation sequencing (comprehensive cancer gene panel or whole genome/exome sequencing) analysis.
Exclusion Criteria:1. 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. 2. 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. 3. Previous treatment with an anti-PD1/PD-L1 including durvalumab or an anti-CTLA-4 therapy including tremelimumab or vinorelbine. 4. Patients with known allergy or severe hypersensitivity to any of the study treatments or any of the study treatment excipients. 5. History of active primary immunodeficiency. 6. 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:
- - Patients with vitiligo or alopecia.
- - Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement therapy.
- - Any chronic skin condition that does not require systemic therapy.
- - Patients without active disease in the last 5 years may be included but only after consultation with the study physician.
- - Patients with celiac disease controlled by diet alone.
- - Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) - Systemic corticosteroids at physiologic doses ≤10 mg/day of prednisone or its equivalent.
- - Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) 11.
- - Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Coordinator.
- - Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Study Coordinator.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Phase 1/Phase 2|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Advanced Solid Tumours, Breast Cancer, Head and Neck Cancer, Cervix Cancer, Prostate Cancer|
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.
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
Drug: - Durvalumab + Tremelimumab + metronomic Vinorelbine
Patient will be treated by metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Active, not recruiting
Centre Antoine Lacassagne
Active, not recruiting