4 completed, 2 active not recruiting, 1 terminated, 1 withdrawn. 5 Phase 2, 4 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 5 | Completed 3, Active not recruiting 1, Terminated 1 |
| Phase 1 | 4 | Completed 2, Active not recruiting 1, Withdrawn 1 |
Follow IRX 2: new trials by email Literature Review of IRX 2 trials Research Report on IRX 2
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Pembrolizumab, IRX-2, and Chemotherapy in Triple Negative Breast Cancer Pembrolizumab, IRX 2 - Breast Cancer, Breast Neoplasms | Phase 2 | Active not recruiting | Providence Health & Services | 12 | 2020-12-30 | 2026-04-24 |
| Nivolumab & IRX-2 With Surgery for Resectable Stage III-IVA Oral Cavity Cancer or HPV-Positive Oropharyngeal Cancer Cyclophosphamide, IRX-2, Nivolumab - Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma, Stage II Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7 | Phase 1 | Withdrawn | Emory University | 2020-07-01 | 2019-08-28 | |
| IRX-2, Cyclophosphamide, and Nivolumab in Treating Patients With Recurrent or Metastatic and Refractory Liver Cancer Cyclophosphamide, Cytokine-based Biologic Agent IRX-2, Nivolumab - Recurrent Hepatocellular Carcinoma, Refractory Liver Carcinoma | Phase 1 | Active not recruiting | City of Hope Medical Center | 8 | 2019-05-17 | 2026-08-21 |
| IRX-2, Cyclophosphamide, and Pembrolizumab in Treating Participants With Recurrent or Metastatic Gastric or Gastroesophageal Junction Cancer Cyclophosphamide, Cytokine-based Biologic Agent IRX-2, Pembrolizumab - Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Phase 1 / Phase 2 | Completed | City of Hope Medical Center | 9 | 2019-04-30 | 2026-10-21 |
| IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors IRX 2, Nivolumab - Metastatic Cancer, Recurrent Cancer | Phase 1 | Completed | H. Lee Moffitt Cancer Center and Research Institute | 12 | 2019-02-13 | 2023-04-14 |
| IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3 Cyclophosphamide, Indomethacin, IRX-2 - Cervical Squamous Cell Carcinoma In Situ, Vulvar High Grade Squamous Intraepithelial Lesion | Phase 2 | Terminated | University of Southern California | 10 | 2017-11-08 | 2025-04-13 |
| IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity IRX-2, Cyclophosphamide, Indomethacin - Squamous Cell Carcinoma of the Oral Cavity | Phase 2 | Completed | Brooklyn ImmunoTherapeutics, LLC | 105 | 2016-01-11 | 2024-01-30 |
| A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer IRX-2, Cyclophosphamide, Indomethacin - Squamous Cell Carcinoma of the Head and Neck | Phase 2 | Completed | Brooklyn ImmunoTherapeutics, LLC | 27 | 2005-07-01 | 2020-12-11 |
Squamous Cell Carcinoma of Head and Neck (4) · Head and Neck Neoplasms (2) · Breast Neoplasms (1) · Carcinoma, Hepatocellular (1) · Carcinoma, Non-Small-Cell Lung (1) · Carcinoma, Renal Cell (1) · Carcinoma, Squamous Cell (1) · Carcinoma, Transitional Cell (1) · Mouth Neoplasms (1) · Neoplasm Metastasis (1) · Neoplasms (1) · Recurrence (1) · Uterine Cervical Dysplasia (1)
Brooklyn ImmunoTherapeutics, LLC (2) · City of Hope Medical Center (2) · Emory University (1) · H. Lee Moffitt Cancer Center and Research Institute (1) · Providence Health & Services (1) · University of Southern California (1)
United States (7) · Brazil (1) · Canada (1) · United Kingdom (1)
Daneng Li (1) · Gregory T Wolf, MD, FACS (1) · Jeffrey S. Moyer, MD (1) · Joseph Chao (1) · Lynda Roman, MD (1) · Mihir Patel, MD (1) · Rohit Jain, MD, MPH (1)
PMID 20539208, PMID 21284052, PMID 22057678, PMID 22109700, PMID 32738599
P30CA014089 (1), P30CA033572 (1)