CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
Cyclophosphamide +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03918499
NCT03918499Phase 2Completed

A Phase 1b/2 Trial of the IRX-2 Regimen and Pembrolizumab in Patients With Advanced Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

City of Hope Medical Center·interventional·Posted Apr 17, 2019·Updated Mar 23, 2023

In Brief

A Phase 2 clinical trial evaluating Cyclophosphamide, Cytokine-based Biologic Agent IRX-2, and 1 other intervention for Clinical Stage IV Gastric Cancer AJCC v8 and 17 related conditions. Completed, enrolled 9 participants across 3 sites.

Detailed Summary

This phase Ib/II trial studies the side effects of IRX-2, cyclophosphamide, and pembrolizumab work in treating participants with gastric or gastroesophageal junction cancer that has come back or that has spread to other places in the body. Interleukins, such as those found in IRX-2, are proteins made by white blood cells and other cells in the body and may help regulate immune response. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving RX-2, cyclophosphamide, and pembrolizumab may work better in treating participants with gastric or gastroesophageal junction cancer.

Study Details

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 17, 2019
Enrollment StartApr 19, 2019
Primary CompletionFeb 9, 2023
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 7.2 years ago

Interventions

Cyclophosphamidedrug

Given IV

Cytokine-based Biologic Agent IRX-2biological

Given SC

Pembrolizumabbiological

Given IV