BP42772:PD-1/TIM-3 & PD-1/LAG-3 vs Nivolumab in Patients with Advanced/Metastatic Esophageal Cancer

• Research type

  Research Study

• Full title

  A 3-ARM, RANDOMIZED, BLINDED, ACTIVE-CONTROLLED, PHASE II STUDY OF RO7121661, A PD1-TIM3 BISPECIFIC ANTIBODY AND RO7247669, A PD1-LAG3 BISPECIFIC ANTIBODY, COMPARED WITH NIVOLUMAB IN PARTICIPANTS WITH ADVANCED OR METASTATIC SQUAMOUS CELL CARCINOMA OF THE ESOPHAGUS

• IRAS ID

  1003646

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2020-004606-60

• Clinicaltrials.gov Identifier

  NCT04785820

• Research summary

  The purpose of this study is to find out what effects, good or bad, RO7121661 and RO7247669, have on participants with Oesophageal Cancer compared to nivolumab.
  RO7121661, RO7247669, and nivolumab belong to a group of medicines called cancer immunotherapeutics. They are designed to block different proteins on the surface of T-cells (a type of immune cell):
  • PD-1, which helps keep the body's immune responses in check. Nivolumab blocks PD-1.
  • TIM-3, plays a role in regulating the body’s immune response. RO7121661 blocks PD1 and TIM3.
  • LAG-3, which also plays a role in regulating the body’s immune response. RO7247669 blocks PD1 and LAG3.
  When these proteins are blocked on specific T-cells, the “brakes” put on the immune system by cancer cells are released, and the ability of T-cells to kill cancer cells is potentially increased.
  RO7121661 and RO7247669 are both experimental study drugs, which means health authorities have not approved them for the treatment of oesophageal cancer. Nivolumab is approved in the UK for the treatment of some cancers, including oesophageal cancer.
  There are 3 treatment groups (RO7121661, RO7247669 and Nivolumab) where participants will be given study drug every 2 weeks for a maximum of 24 months, unless the cancer worsens. Study participation will depend on how long it takes the cancer to respond, which could range from 1 day to 24 months. After the final dose the Investigator will, follow-up with the participant every 3 months until the participant agrees or study closes. Neither the participant nor the site staff will know which treatment group they are in.

  Approximately 26 participants will take part in the study in the UK and 255 worldwide.

  The study is sponsored by F. Hoffman La Roche

  Research Summary; Version 1 and 11-Feb-2021;

• REC name

  West of Scotland REC 1

• REC reference

  21/WS/0035

• Date of REC Opinion

  17 May 2021

• REC opinion

  Further Information Favourable Opinion