Phase 2 open-label study with GS-5745 in subjects with gastric cancer
Research type
Research Study
Full title
A Phase 2, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of GS-5745 Combined with Nivolumab versus Nivolumab Alone in Subjects with Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma
IRAS ID
211983
Contact name
Richard Hubner
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2016-001402-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 1 months, 26 days
Research summary
Adenocarcinoma of the stomach is the most common gastrointestinal cancer in the world and the third leading cause of cancer death worldwide. Adenocarcinoma of the gastroesophageal junction is one of the most rapidly increasing solid tumours in the US and Western Europe. Initial (first line) treatment is chemotherapy and there is no standard approach for second line therapy after failure of the first line chemotherapy.
This study will evaluate the safety and efficacy of new drug GS-5745 in patients with gastric cancer when used in combination with nivolumab versus nivolumab alone.
GS-5745 is being developed by Gilead Sciences, Inc. for the treatment of gastric cancer by blocking the action of a protein called MMP9, which may have a key role in helping tumours grow. By blocking MMP9, GS-5745 may slow or stop the progression of gastric cancer. Nivolumab is a drug which is commercially available for treatment in other cancers, but is not yet approved for gastric cancer. This drug is thought to increase the ability of a patient’s immune system to fight tumour cells.
Approximately 120 participants will take part at around 50 sites globally.
Participation in the study may last up to 5 years, for most patients, study involvement will be much shorter; participants may receive treatment for up to 2 years, involving a total of at least 50 visits. Participants will be randomised in a 1:1 ratio to receive either GS-5745 + nivolumab or nivolumab only.
Participants will be selected by chance to receive 1 of the following:
Treatment Group A: approximately 60 participants will receive GS-5745 + nivolumab
Treatment Group B: Approximately 60 participants will receive nivolumab
These medications will be provided by Gilead.The safety and tolerability of these drugs will be determined by physical examinations, laboratory tests, and any symptoms or problems the participants may experience during the study.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
16/EM/0408
Date of REC Opinion
7 Nov 2016
REC opinion
Further Information Favourable Opinion