CA224-060 Relatlimab, Nivolumab & Chemotherapy in Gastric Cancer

• Research type

  Research Study

• Full title

  A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (anti-LAG-3) plus Nivolumab in Combination with Chemotherapy Versus Nivolumab in Combination with Chemotherapy as First-Line Treatment in Patients with Gastric or Gastroesophageal Junction Adenocarcinoma

• IRAS ID

  247545

• Contact name

  Nicholas Maisey

• Contact email

  nick.maisey@gstt.nhs.uk

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Eudract number

  2018-001069-18

• Clinicaltrials.gov Identifier

  IND number, 137,615

• Duration of Study in the UK

  4 years, 6 months, 12 days

• Research summary

  This is a multicentre, phase 2 study of the investigational drug called BMS-986213 (fixed dose combination of Nivolumab and Relatlimab), given in combination with chemotherapy, in patients with inoperable, locally advanced or metastatic gastric or gastroesophageal junction who have not received treatment before Nivolumab and Relatlimab are immunotherapy drugs designed to stimulate the body’s own immune system to help attack cancer cells.
  This study will assess if BMS-986213, given together with chemotherapy, increases the survival of patients, who have inoperable or metastatic gastric or gastroesophageal cancer, and whether it delays the progression of their cancer (when compared to chemotherapy alone).
  250 patients, aged 18 years or older, will take part globally in this study, 24 of them will be in the UK.
  After a screening period, patients will randomly receive one of the following treatments:
  • BMS-986213 plus chemotherapy
  • Nivolumab plus chemotherapy

  Most of the drugs are given through a vein but there is also some oral chemotherapy medication (depends on which chemotherapy regimen your study doctor gives you). This is an open label study, so patients and doctors will know what treatment patients will receive.
  During their study participation, patients will have physical examinations (including vital signs [e.g. heart rate and blood pressure] and weight), scans, biopsies (if needed), ECGs and blood samples for safety and for study-specific tests, Patients will receive the drugs until, they withdraw their consent to receive the study drugs, or they no longer tolerate the study treatment or their cancer gets worse.
  The study is paid by Bristol-Myers Squibb (BMS).

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  18/SC/0429

• Date of REC Opinion

  4 Sep 2018

• REC opinion

  Favourable Opinion