Nivolumab monotherapy in patients with Non-Small Cell Lung Cancer
Research type
Research Study
Full title
An Open-Label, Multicenter Clinical Trial with Nivolumab (BMS-936558) Monotherapy in Subjects with Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) who Have Received at Least One Prior Systemic Regimens for the Treatment of Stage IIIb/IV SqNSCLC
IRAS ID
174324
Contact name
Sanjay Popat
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2014-001285-10
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
The sponsor, Bristol-Myers Squibb has developed an investigational drug called Nivolumab (BMS936558) which is currently being studied in patients with Non-Small Cell Lung Cancer (NSCLC). Nivolumab is a protein drug (monoclonal antibody) which works by enabling the immune system to attack and kill cancer cells.
This is a clinical trial for patients who have been diagnosed as having squamous NSCLC which has progressed during or after receiving a minimum of 2 prior systemic treatments.
This study will assess safety events, estimate overall survival and partial or complete response.
Approximately 1800 patients from around Europe will take part in this study with 220 from the UK. Participants will receive 3mg/kg of nivolumab directly into the vein every 2 weeks. Each cycle of treatment is 14 days. Participants may continue to receive the study drug for 1 year, until their disease progresses (although they may be still treated under certain circumstances) or they do not tolerate the treatment (toxicity). After 1 year, participants who are still benefitting from therapy will be randomly allocated into one of two groups:
Cohort A: participants will continue to receive nivolumab until progression, toxicity or until they withdraw consent.
Cohort B: participants will stop nivolumab, but remain in the study and may re-start nivolumab upon progression and then continue treatment until progression, toxicity or until they withdraw consent.
After the treatment ends, participants will continue to be monitored to gather additional information about their disease, further treatments and survival.
This study involves assessments including: medical history, physical examinations, questionnaires, status assessments, blood tests, pregnancy testing, vital signs and level of blood oxygen. Participants will have a CT scan (specialised X-ray test) at screening, at week 8, then as per standard of care.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
15/LO/0691
Date of REC Opinion
14 May 2015
REC opinion
Favourable Opinion