18 and older, any sex, with Clinical Stage IV Gastric Cancer AJCC v8 or Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free SurvivalPrimary· From first day of study drug administration to disease progression or death, assessed up to 2 years
Estimated using the product-limit method of Kaplan and Meier. From initial treatment until progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Group
Value
95% CI
Treatment (Pembrolizumab, Cyclophosphamide, and IRX-2)
1.1
0.4 – 2.0
Overall SurvivalSecondary· Up to 2 years
Estimated using the product-limit method of Kaplan and Meier. From the time of initial treatment until death from any cause.
Group
Value
95% CI
Treatment (Pembrolizumab, Cyclophosphamide, and IRX-2)
2.9
0.4 – 8.7
Overall ResponseSecondary· Up to 2 years
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Group
Value
95% CI
Treatment (Pembrolizumab, Cyclophosphamide, and IRX-2)
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events occurred over a period of 2 years and 6 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment (Pembrolizumab, Cyclophosphamide, and IRX-2)
Serious: 2/9 (22%)
Deaths: 9/9
Serious adverse events (3 terms)
Reaction
System
Treatment (Pembrolizumab, …
Pericardial effusion
Cardiac disorders
—
Small intestinal obstruction
Gastrointestinal disorders
—
Pneumothorax
Respiratory, thoracic and mediastinal disorders
—
Other adverse events (108 terms — click to expand)
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che
· Phase 2
· not yet recruiting
NCT07509008 — Phase 1/2 Window Of Opportunity Study Of TROP2 CAR/IL-15 TGFBR2 KO NK Cells Delivered Intraperitoneally For The Manageme
· Phase 1, PHASE2
· not yet recruiting
NCT07444632 — Phase1 Basket Trial Of CAR.70-Engineered IL15-Transduced With TGFBR2 Knock Out Cord Blood-Derived NK Cells For Relapsed/
· Phase 1
· not yet recruiting
NCT07444710 — Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP)
· Phase 1
· not yet recruiting
NCT07437963 — Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatmen
· Phase 1, PHASE2
· not yet recruiting
Other recruiting trials for Clinical Stage IV Gastric Cancer AJCC v8
Currently open trials in the same condition.
NCT06364410 — Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients Wi
· Phase 1
· recruiting
NCT05911243 — Feasibility of Auricular Acupressure for Appetite and Weight in Patients With Stage II-IV Gastric, Esophageal, and Pancr
· NA
· recruiting
NCT06203600 — Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
· Phase 2, PHASE3
· recruiting
NCT05802056 — Aldesleukin With Nivolumab and Standard Chemotherapy for Treatment of Gastric Cancer With Peritoneal Metastasis
· Phase 1
· recruiting
NCT05677490 — mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Neg
· Phase 3
· recruiting
Other City of Hope Medical Center trials
Trials by the same sponsor.
NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant
· Phase 2
· not yet recruiting
NCT07218692 — RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy
· Phase 2
· not yet recruiting
NCT07363408 — Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment
· Phase 1
· not yet recruiting
NCT07226102 — Virtual Mental Health Intervention to Address Fear of Progression for Women With High Risk or Stage III-IV Gynecologic o
· NA
· withdrawn
NCT07225855 — Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Can
· NA
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by City of Hope Medical Center
Last refreshed: 23 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03918499.