This phase III trial is evaluating the safety and effectiveness of adding an immunotherapy (Pembrolizumab) to a combination treatment with another immunotherapy (Trastuzumab) and standard of care (SOC) chemotherapy in patients with HER2 positive stomach cancers.
This trial is treating patients with HER-2 positive gastric (stomach) or gastro-oesophageal cancer.
This is a systemic therapy trial.
You may be able to join this trial if:
- You have been diagnosed with cancer, but have not received any treatment.
- Your cancer has spread to other parts of the body.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have been diagnosed with a prior or secondary type of cancer.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
Use the hyperlinks, where available to access additional clinical trial information.
A Phase III, Randomized, Double-blind Trial Comparing Trastuzumab Plus Chemotherapy and Pembrolizumab With Trastuzumab Plus Chemotherapy and Placebo as First-line Treatment in Participants With HER2 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
This is a randomised trial with quadruple masking. In this trial, participants will receive intravenous Pembrolizumab (200mg) or placebo on day-1 of each 3-week cycle. Trastuzumab will also be administered on day-1 of each 3- week cycle (at a 8mg/kg loading dose and 6mg/kg maintenance dose). Either FP or CAPOX standard of care (SOC) chemotherapy will be administered to the global cohort. FP chemotherapy includes 80 mg/m^2 cisplatin administered IV on Day 1 of each 3-week cycle and 800 mg/m^2 5-fluorouracil [5-FU] administered IV on Days 1-5 of each 3-week cycle. CAPOX includes 1000 mg/m^2 capecitabine administered orally twice daily [BID] on days 1-14 of each 3-week cycle and 130 mg/m^2 oxaliplatin administered IV on Day 1 of each 3-week cycle.
Recruiting Hospitals Read More