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

NCT04069273 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-07-31

No results posted yet for this study

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

Interventions

DRUG

Pembrolizumab Monotherapy

Pembrolizumab 200 mg IV

DRUG

Ramucirumab

Ramucirumab 10 mg/kg IV

DRUG

Paclitaxel

Paclitaxel 90 mg/m2 IV

Sponsors & Collaborators

Principal Investigators

  • Harry H Yoon, MD, MHS · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2026-06-11
Completion
2026-12-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04069273 on ClinicalTrials.gov