NCT04069273

Novel SEQUEnced Immunotherapy With Anti-angiogenesis and Chemotherapy in Advanced gastroesophageaL Adenocarcinoma

Phase 2 Study of Novel SEQUEnced Immunotherapy (Pembrolizumab) With Anti-angiogenesis and Chemotherapy in Advanced Gastric and gastroesophageaL Junction (GEJ) Adenocarcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Harry H Yoon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cohort 1 \[CLOSED\] Study treatment involves two segments: (1) Induction Immunotherapy segment with pembrolizumab monotherapy every 3 weeks until irRECIST PD and (2) Combination Therapy segment. Nab-paclitaxel may be utilized in place of paclitaxel at investigator's discretion for subjects with paclitaxel reactions. Cohort 2 Patients are randomized to Arm A or B. Treatment in both arms includes pembrolizumab + RAM + paclitaxel.

Conditions

• Gastric Cancer
• GastroEsophageal Cancer
• Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab Monotherapy	Pembrolizumab 200 mg IV
DRUG	Ramucirumab	Ramucirumab 10 mg/kg IV
DRUG	Paclitaxel	Paclitaxel 90 mg/m2 IV

Timeline

• Start date: 2020-12-01
• Primary completion: 2026-06-11
• Completion: 2026-12-10
• First posted: 2019-08-28
• Last updated: 2025-07-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study