CA209-358 Nivolumab in virus positive and virus negative tumors
Research type
Research Study
Full title
Non-Comparative, Two-Cohort, Single-Arm, Open-Label, Phase 1/2 Study of Nivolumab (BMS-936558) in Subjects with Virus-Positive and Virus-Negative Solid Tumors
IRAS ID
184944
Contact name
Milagros Blazquez
Contact email
Sponsor organisation
Bristol-Myers Squibb
Eudract number
2015-000230-29
Duration of Study in the UK
2 years, 9 months, 1 days
Research summary
Summary of Research
This is a multicentre, phase 1/2 study involving an investigational drug called Nivolumab given alone in patients with pre-operative Squamous Cell Carcinoma of Head and Neck (SCCHN); Cervical, Vaginal, Vulvar carcinoma (GYN); or Merkel cell carcinoma (MCC); or patients with metastatic viral positive SCCHN; viral positive gastric cancer (GC); GYN; MCC; or Nasopharyngeal carcinoma (NPC).
In patients with pre-operative disease the purpose of the study is to define the safety and tolerability of the drug. In patients with metastatic disease the purpose is to determine if treatment with Nivolumab will lead to clinical benefit in patients in those tumour types.
For patients with metastatic disease treatment options are limited. For GC, NPC the prognosis is low despite treatment options. For NPC there is no current standard of care (SOC) and for GYN there is no SOC after first line. For metastatic MCC is incurable with current chemotherapy.
Approximately 84 pre-operative and 115 metastatic patients will take part globally with 20 coming from the UK. The study is sponsored by Bristol-Myers Squibb
Following a screening period eligible patients with pre-operative disease will receive 2 doses of nivolumab intravenously (through your vein) followed by further biopsy or surgery. Patients will then receive standard of care treatment. Those patients with metastatic disease, or if eligible those who progress after pre-operative SOC, will receive nivolumab intravenously every 2 weeks and can remain in the study for as long as they are tolerating the treatment or until it has been confirmed that their cancer has worsened.
Patients will undergo the following study procedures: Tumour biopsy (if not already available), CT/MRI, physical exams, vital signs such as blood pressure, height, weight, body temperature, blood samples for routine safety testing and study specific testing. Patients will also be required to complete questionnaires regularly throughout the study.Summary of Results
PLS is now available and will be shared (pdf) with sites and participants. No URL is available.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
15/NW/0618
Date of REC Opinion
28 Aug 2015
REC opinion
Further Information Favourable Opinion