CA224-020 Anti-LAG-3 with Nivolumab in Advanced Soild Tumors

• Research type

  Research Study

• Full title

  A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination with Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors

• IRAS ID

  198197

• Contact name

  James Larkin

• Contact email

  james.larkin@rmh.nhs.uk

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Eudract number

  2014-002605-38

• Clinicaltrials.gov Identifier

  NCT01968109

• Clinicaltrials.gov Identifier

  117607, IND number

• Duration of Study in the UK

  2 years, 3 months, 0 days

• Research summary

  The purpose of this phase 1/2a study is to test the safety, tolerability & efficacy of an investigational drug called BMS-986016 (known as anti-LAG-3) given alone or in combination with BMS drug called nivolumab (known as BMS-936558) for patients with advanced solid tumors. This study is split into 3 parts (A, B & C).

  Part A: Dose escalation with Anti Lag-3
  Part B: Dose escalation with Anti Lag-3 & Nivolumab
  Part C*: Dose expansion with Anti Lag-3 & Nivolumab
  *Patients in the UK will be entering PART C

  This study was also used to identify the highest dose of anti-LAG-3 that was tolerated alone and in combination with nivolumab. The information that was collected from that part of the study (PART B) was used to select the dose of anti-LAG-3 and nivolumab that will be tested in PART C (expansion part) of the study.
  The purpose of the expansion part (PART C) of the study is to further test the safety of the combination of anti-LAG-3 and nivolumab and to see how patients will tolerate the drugs. Another purpose, is to obtain initial information about the effectiveness of the combination of the investigational drugs in patients with specific types of cancers (Skin, non small cell lung cancer, head and neck cancer, renal (Kidney) cell carcinoma, liver cancer, and stomach cancer).

  Following a screening period, eligible patients will receive nivolumab in combination with anti-LAG-3. All medications are given intravenously (through a vein).

  Patients will complete up to 4 periods of the study: Screening (up to 28 days), Treatment (up to a maximum of twelve 8-week cycles of study therapy), Clinical Follow-up (135 days), and Survival Follow-up (up to 2 years following the first dose of study drug.

  Patients will be followed regularly throughout the trial, with physical exams, vital signs, blood tests, chest x-rays, CT/MRI scans, and monitoring of the heart (with ECGs), to ensure on-going safety within the trial.

  Up to 450 patients in total are expected to participate globally in the dose expansion of this study

• REC name

  London - City & East Research Ethics Committee

• REC reference

  16/LO/1199

• Date of REC Opinion

  23 Aug 2016

• REC opinion

  Further Information Favourable Opinion