NCT04249739

Pembrolizumab + Capecitabine／Oxaliplatin (CapeOx) -HER2 Nagative and Pembrolizumab + Trastuzumab + Cisplatin/Capecitabine HER2 Positive

Phase II Study of Pembrolizumab + Capecitabine／Oxaliplatin (CapeOx)(HER2 Negative ARM) or Pembrolizumab + Trastuzumab+ Capecitabine／Cisplatin (HER2 Positive ARM) in Metastatic GC as First-line Treatment

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, single arm, phase II trial the efficacy and safety of pembrolizumab + CapeOx (HER2 negative ARM) or pembrolizumab + Trastuzumab + Capecitabine/Cisplatin (HER2 positive ARM) as first line therapy in advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Detailed description

Cohort A is allocated for the patients with Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma who confirmed with HER2 negative, and approximately 78 subjects will be enrollment to evaluate the efficacy and safety of pembrolizumab + Capecitabine/oxaliplatin. Cohort B is allocated for the patients with Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma who confirmed with HER2 positive, and approximately 15 subjects will be enrollment to evaluate the efficacy and safety of pembrolizumab + Trastuzumab + Capecitabine/Cisplatin (1 Cycle: Day 1 through Day 21) Planned Biopsy Analysis immediate pre-treatment biopsy before chemotherapy; Newly-obtained specimens are defined as FFPE-preserved blocks or fresh tissue collected up to 12 weeks prior to C1D1. 2.on treatment primary tumor biopsy (C2D1 - 3 days window; before administration of C2D1) to explore whether tumor has change in characters (i.e., immune desert to immune infiltration) 3.on treatment primary tumor biopsy (C7D1 - 3 days window; before administration of C7D1) to explore whether tumor has change in characters (i.e., immune desert to immune infiltration) 4.At progression biopsy will be optional whenever the tumor biopsy is feasible.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Keytruda ™ (pembrolizumab) has recently been approved in the United Stated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.

Timeline

• Start date: 2020-09-29
• Primary completion: 2024-02-06
• Completion: 2025-03-01
• First posted: 2020-01-31
• Last updated: 2024-03-13

Locations

1 site across 1 country: South Korea