CA209-451 Nivolumab vs Nivolumab/Ipilimumab or Placebo in ED-SCLC

• Research type

  Research Study

• Full title

  A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination with Ipilimumab, or Placebo as Maintenance Therapy in Subjects with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) after Completion of Platinum-based First Line Chemotherapy

• IRAS ID

  188945

• Contact name

  Katia Kempinaire

• Contact email

  katia.kempinaire@bms.com

• Sponsor organisation

  Bristol-Myers Squibb Pharmaceuticals Ltd

• Eudract number

  2015-002441-61

• Clinicaltrials.gov Identifier

  NCT02538666

• Duration of Study in the UK

  3 years, 8 months, 18 days

• Research summary

  Summary of Research
  A clinical trial of Nivolumab; Nivolumab with Ipilimumab, or Placebo in patients with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC). Lung cancer is the second most common cancer in the UK and the most common cause of cancer related deaths in men and women. A significant number of patients have advanced lung cancer at diagnosis. Unfortunately with current standard of care chemotherapy, the survival rate remains poor, with less than 5% of advanced lung cancer patients alive five years on from diagnosis. There is a clear unmet medical need for patients with advanced SCLC.

  Nivolumab, is a new type of immunotherapy drug which stimulates the body’s own immune system to help attack cancer cells. It works by blocking a protein on the body’s immune cells, called PD1, so that tumours can be recognised as foreign and attacked by the immune system. Ipilimumab is already on the market in the UK for the treatment of melanoma, a type of skin cancer.

  Following a screening period, eligible patients will be randomized to 1 of 3 treatment arms. Patients will receive either Nivolumab, Nivolumab with Ipilimumab or Placebo until their cancer gets worse or their doctor decides they should come out of the study. Patients will undergo the following procedures during the study: tumour tissue biopsy (possible), CT/MRI scans, ECG, physical exams, vital signs and blood sampling for routine safety testing and study specific testing.
  Patients will be treated by trained oncology teams in specialised NHS clinics. 810 patients are to be treated in the study with approximately 24 being treated in the UK. The study is sponsored by Bristol-Myers Squibb.

  Summary of Results
  please refer to clinicaltrials.gov

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  15/EE/0418

• Date of REC Opinion

  30 Dec 2015

• REC opinion

  Further Information Favourable Opinion