KEYNOTE 811 : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Stomach<br/>CancersCancer LocationStomach
Cancers

Systemic therapy | Stomach and upper gastrointestinal tractGastro-oesophageal junction ,Oesophagus,Stomach

Trial Overview Read MoreRead more

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 MoreRead more

Trial Identifiers

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Scientific Title

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

Commercial Sponsor

Merck

Summary

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 MoreRead more

Monash Health, Medical Oncology
Clayton
GI Research Study Coordinator
gi.oncresearch@monashhealth.org

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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