At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed HER2-positive gastric or GEJ adenocarcinoma, locally advanced unresectable or metastatic, previously untreated
- ✓HER2-positive defined as IHC 3+ or IHC 2+ with ISH+ or FISH on primary or metastatic tumor by central review
- ✓Measurable disease by RECIST 1.1
- ✓ECOG performance status 0 or 1
- ✕Prior systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer
- ✕Major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization
- ✕Radiotherapy within 14 days of randomization
- ✕Known active CNS metastases and/or carcinomatous meningitis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 (KEYNOTE 811)
In Brief
A Phase 3 clinical trial evaluating Pembrolizumab, Placebo, and 6 other interventions for Gastric Neoplasms and Gastroesophageal Junction Adenocarcinoma. Completed, enrolled 738 participants across 192 sites in 20 countries.
Detailed Summary
The study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive gastric cancer. The primary hypotheses of the study are that pembrolizumab plus trastuzumab in combination with chemotherapy is superior to trastuzumab plus chemotherapy in terms of 1) progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), and 2) overall survival (OS).
Study Details
Timeline
Interventions
200 mg on Day 1 of each 3-week cycle as an IV infusion.
Solution for IV infusion on Day 1 of each 3-week cycle.
80 mg/m\^2 on Day 1 of each 3-week cycle as an IV infusion, administered as part of FP chemotherapy regimen.
800 mg/m\^2/day continuous on Days 1-5 of each 3-week cycle (120 hours or per local standard), administered as part of FP chemotherapy regimen.
130 mg/m\^2 on Day 1 of each 3-week cycle over 2 hours as an IV infusion, administered as part of CAPOX chemotherapy regimen and as part of SOX chemotherapy regimen.
1000 mg/m\^2 as oral capsules BID on Days 1-14 of each 3-week cycle, administered as part of CAPOX chemotherapy regimen.
Combination product of tegafur, CDHP, and Oxo. Oral capsules BID on Days 1-14 of each 3-week cycle based on body surface area (BSA): \<1.25 m\^2 BSA =40 mg, 1.25 to \<1.5 m\^2 BSA=50 mg, ≥1.5 m\^2 BSA=60 mg. Administered as part of SOX chemotherapy regimen.
8 mg/kg loading dose and then 6 mg/kg maintenance dose administered IV on day 1 of each 3-week cycle.