A multicenter phase II study evaluating denosumab (XGEVA®) in combination with nivolumab (OPDIVO®) as second-line therapy for patients with stage IV non-small–cell lung cancer (squamous and non-squamous) with bone metastases - DENIVOS

Centre Hospitalier Annecy Genevois0 sites86 target enrollmentApril 27, 2018

Overview

No summary available.

Registry

who.int

Start Date

April 27, 2018

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- \=18 years old;
•\- Cytologically or histologically proven stage IV Non\-Small Cell Lung Cancer;
•\- ECOG PS 0/1;
•\- For non\-squamous cell Non\-Small Cell Lung Cancer, patients without activating Epidermal Growth Factor\-Receptor mutation, Anaplastic Lymphoma Kinase or ROS\-1 translocation, or BRAF V600 mutation.
•\- Patients who had received first\-line platin salt\-based chemotherapy and will be given second\-line nivolumab;
•\- Patients with bone metastases, symptomatic or not, confirmed by X\-rays, CT scan, MRI, PET–CT scan or technetium bone scintigraphy;
•\- Presence of at least 1 measurable target lesion, according to RECIST criteria 1\.1, in a non\-irradiated site;
•\- PD\-L1 status known and expressed as a percentage of tumor cells; assessed at the diagnosis or the more recent PD\-L1 expression status available.
•\- Estimated life\-expectancy \=12 weeks;
•\- No prior malignant tumor during the previous 5 years, except for adequately treated in situ carcinomas of the cervix or basal or squamous cell carcinomas of the skin;

•\- Patients previously treated with bisphosphonates and/or denosumab;
•\- Patients previously treated with immunotherapy;
•\- Patients with symptomatic cerebral metastases;
•\- Contraindication to nivolumab use:
•\- Prior autoimmune disease(s), define as disease required systemic treatment in the past (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
•\- Prior diffuse interstitial pneumopathy,
•\- Systemic immunosuppressive therapy; define as steroid medication at a dose greater than Prednisone 10 mg/day or equivalent. For patients with MMR\-deficient high\-grade gliomas, concurrent steroid medication at a dose greater than Prednisone 20mg/day or equivalent.
•\- Contraindication for denosumab use:
•\- Poor dental status requiring immediate specialized management, like oral surgery,
•\- Prior or current signs of osteonecrosis of the jaw/osteomyelitis,