Table 9.
Clinical Trials of microorganisms applied for cancer theranostics
| Microorganisms | Tumor type | Clinical Studies | Year | Database (ID) |
|---|---|---|---|---|
| T4 phage | Skin Cancer | T4N5 Liposomal Lotion in Preventing the Recurrence of Nonmelanoma Skin Cancer in Patients Who Have Undergone a Kidney Transplant | 2004-2007 | ClinicalTrials.gov [a] (NCT00089180) |
| MV-CEA, and MV-NIS (Oncolytic virus) | Ovarian cancer | Recombinant Measles Virus Vaccine Therapy and Oncolytic Virus Therapy in Treating Patients with Progressive, Recurrent, or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer | 2004-2017 | ClinicalTrials.gov (NCT00408590) |
| GL-ONC1 (Oncolytic virus) | Solid Tumors | Safety Study of GL-ONC1, an Oncolytic Virus, in Patients with Advanced Solid Tumors | 2008-2015 | ClinicalTrials.gov (NCT00794131) |
| CG0070 (Oncolytic virus) | Bladder Cancer | Safety and Efficacy of CG0070 Oncolytic Virus Regimen for High Grade NMIBC After BCG Failure | 2015-2019 | ClinicalTrials.gov (NCT02365818) |
| TBI-1401 (HF10) (Oncolytic virus) | Solid Tumor | A Study of TBI-1401(HF10) in Patients with Solid Tumors with Superficial Lesions | 2015-2107 | ClinicalTrials.gov (NCT02428036) |
| Enadenotucirev (Oncolytic virus) | Ovarian Cancer | Phase I / Dose Expansion Study of Enadenotucirev in Ovarian Cancer Patients | 2014-2019 | ClinicalTrials.gov (NCT02028117) |
| Enadenotucirev (Oncolytic virus) | Solid Tumours | Phase I / II Study of Enadenotucirev by Sub-acute Fractionated IV Dosing in Cancer Patients | 2012-2016 | ClinicalTrials.gov (NCT02028442) |
| G207 (Oncolytic virus) | Brain Cancer | Safety and Effectiveness Study of G207, a Tumor-Killing Virus, in Patients with Recurrent Brain Cancer | 2001-2003 | ClinicalTrials.gov (NCT00028158) |
| Colo-Ad1 (Oncolytic virus) | Colon Cancer; Non-small Cell Lung Cancer; Bladder Cancer; Renal Cell Carcinoma | Mechanism of Action Trial of ColoAd1 | 2013-2016 | ClinicalTrials.gov (NCT02053220) |
| ONCOS-102 (Oncolytic virus) | Solid Tumour | ONCOS-102 (Previously CGTG-102) for Therapy of Advanced Cancers | 2012-2013 | ClinicalTrials.gov (NCT01598129) |
| HSV1716 (Oncolytic virus) | Solid Tumour | HSV1716 in Patients with Non-Central Nervous System (Non-CNS) Solid Tumors | 2010-2018 | ClinicalTrials.gov (NCT00931931) |
| DNX-2401 (Oncolytic virus) | Brain Tumors | DNX-2401 With Interferon Gamma (IFN-γ) for Recurrent Glioblastoma or Gliosarcoma Brain Tumors | 2014-2018 | ClinicalTrials.gov (NCT02197169) |
| VCN-01 | Solid Tumors | Phase I Dose Escalation Study of Intravenous VCN-01 With or Without Gemcitabine and Abraxane® in Patients with Advanced Solid Tumors | 2014-2020 | ClinicalTrials.gov (NCT02045602) |
| Ad-MAGEA3, MG1-MAGEA3 (Oncolytic virus) | Non-Small Cell Lung Cancer | Oncolytic MG1-MAGEA3 With Ad-MAGEA3 Vaccine in Combination with Pembrolizumab for Non-Small Cell Lung Cancer Patients | 2017-2020 | ClinicalTrials.gov (NCT02879760) |
| HSV1716 (Oncolytic virus) | Mesothelioma | Intrapleural Administration of HSV1716 to Treat Patients with Malignant Pleural Mesothelioma | 2012-2016 | ClinicalTrials.gov (NCT01721018) |
| REOLYSIN® (Oncolytic virus) | Colorectal Cancer | Study of REOLYSIN® in Combination with FOLFIRI and Bevacizumab in FOLFIRI Naive Patients With KRAS Mutant Metastatic Colorectal Cancer | 2010-2018 | ClinicalTrials.gov (NCT01274624) |
| GL-ONC1 (Oncolytic virus) | Cancer of Head and Neck | Safety Study of Attenuated Vaccinia Virus (GL-ONC1) with Combination Therapy in Head & Neck Cancer | 2012-2015 | ClinicalTrials.gov (NCT01584284) |
| JX-594 (Oncolytic virus) | Hepatic Carcinoma | A Study of Recombinant Vaccinia Virus to Evaluate the Safety and Efficacy of a Transdermal Injection Within the Tumor of Patients with Primary or Metastatic Hepatic Carcinoma | 2006-2007 | ClinicalTrials.gov (NCT00629759) |
| JX-594 (Oncolytic virus) | Liver Cancer | A Phase 2b Study of Modified Vaccinia Virus to Treat Patients Advanced Liver Cancer Who Failed Sorafenib | 2008-2011 | ClinicalTrials.gov (NCT01387555) |
| DNX-2401 (Oncolytic virus) | Brain Cancer | Combination Adenovirus + Pembrolizumab to Trigger Immune Virus Effects | 2016-2021 | ClinicalTrials.gov (NCT02798406) |
| REOLYSIN® (Oncolytic virus) | Non-small Cell Lung Carcinoma | Phase 2 Study of REOLYSIN® in Combination with Paclitaxel and Carboplatin for Non-Small Cell Lung Cancer With KRAS or EGFR Activation | 2009-2015 | ClinicalTrials.gov (NCT00861627) |
| CVA21 (Oncolytic virus) | Uveal Melanoma; Liver Metastases | CAVATAK® and Ipilimumab in Uveal Melanoma Metastatic to the Liver (VLA-024 CLEVER) | 2018-2019 | ClinicalTrials.gov (NCT03408587) |
| JX-594 (Oncolytic virus) | Solid Tumors | Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors | 2008-2014 | ClinicalTrials.gov (NCT00625456) |
| VCN-01 (Oncolytic virus) | Pancreatic Adenocarcinoma | A Phase I Dose Escalation Study of Intratumoral VCN-01 Injections with Gemcitabine and Abraxane® in Patients with Advanced Pancreatic Cancer | 2014-2018 | ClinicalTrials.gov (NCT02045589) |
| JX-594 (Oncolytic virus) | Solid Tumors | Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors in Pediatric Patients | 2010-2014 | ClinicalTrials.gov (NCT01169584) |
| REOLYSIN® (Oncolytic virus) | Malignant Glioma | Safety and Efficacy Study of REOLYSIN® in the Treatment of Recurrent Malignant Gliomas | 2006-2010 | ClinicalTrials.gov (NCT00528684) |
| GL-ONC1 (Oncolytic virus) | Peritoneal Carcinomatosis | A Study of GL-ONC1, an Oncolytic Vaccinia Virus, in Patients with Advanced Peritoneal Carcinomatosis | 2012-2014 | ClinicalTrials.gov (NCT01443260) |
| TBI-1401 (HF10) (Oncolytic virus) | Melanoma | A Study of Combination With TBI-1401(HF10) and Ipilimumab in Japanese Patients with Unresectable or Metastatic Melanoma | 2017-2018 | ClinicalTrials.gov (NCT03153085) |
| HF10 (Oncolytic virus) | Melanoma | A Study of Combination Treatment with HF10 and Ipilimumab in Patients With Unresectable or Metastatic Melanoma | 2014-2018 | ClinicalTrials.gov (NCT02272855) |
| JX-594 (Oncolytic virus) | Colorectal Carcinoma | Recombinant Vaccinia Virus Administered Intravenously in Patients with Metastatic, Refractory Colorectal Carcinoma | 2012-2015 | ClinicalTrials.gov (NCT01394939) |
| REOLYSIN® (Oncolytic virus) | Sarcomas | Safety and Efficacy Study of REOLYSIN® in the Treatment of Bone and Soft Tissue Sarcomas Metastatic to the Lung | 2007-2011 | ClinicalTrials.gov (NCT00503295) |
| CVA21(Oncolytic virus) | Melanoma | A Study of Intratumoral CAVATAK™ in Patients With Stage IIIc and Stage IV Malignant Melanoma (VLA-007 CALM ) | 2011-2016 | ClinicalTrials.gov (NCT01227551) |
| JX-594 (Oncolytic virus) | Melanoma | A Study of Recombinant Vaccinia Virus to Treat Malignant Melanoma | 2007-2009 | ClinicalTrials.gov (NCT00429312) |
| CVA21(Oncolytic virus) | Melanoma | A Safety Study of Two Intratumoural Doses of Coxsackievirus Type A21 in Melanoma Patients (PSX-X03) | 2007-2009 | ClinicalTrials.gov (NCT00438009) |
| ParvOryx (Oncolytic virus) | Glioblastoma | Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme. | 2011-2015 | ClinicalTrials.gov (NCT01301430) |
| REOLYSIN® (Oncolytic virus) | Pancreatic Adenocarcinoma | Study of Pembrolizumab With REOLYSIN® and Chemotherapy in Patients With Advanced Pancreatic Adenocarcinoma | 2015-2018 | ClinicalTrials.gov (NCT02620423) |
| DNX2401 (Oncolytic virus) | Glioblastoma | Virus DNX2401 and Temozolomide in Recurrent Glioblastoma | 2013-2017 | ClinicalTrials.gov (NCT01956734) |
| REOLYSIN® (Oncolytic virus) | Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer | Paclitaxel With or Without Viral Therapy in Treating Patients with Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer | 2010-2020 | ClinicalTrials.gov (NCT01199263) |
| MV-NIS (Oncolytic virus) | Myeloma | UARK 2014-21 A Phase II Trial of Oncolytic Virotherapy by Systemic Administration of Edmonston Strain of Measles Virus | 2015-2019 | ClinicalTrials.gov (NCT02192775) |
| Pexa Vec (Oncolytic virus) | Hepatocellular Carcinoma | Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone | 2015-2020 | ClinicalTrials.gov (NCT02562755) |
| JX-594 (Oncolytic virus) | Hepatocellular Carcinoma | A Study of Recombinant Vaccinia Virus to Treat Unresectable Primary Hepatocellular Carcinoma | 2008-2013 | ClinicalTrials.gov (NCT00554372) |
| MV-NIS (Oncolytic virus) | Mesothelioma | Intrapleural Measles Virus Therapy in Patients with Malignant Pleural Mesothelioma | 2011-2019 | ClinicalTrials.gov (NCT01503177) |
| T-VEC (Oncolytic virus) | Melanoma | A Study of Talimogene Laherparepvec in Stage IIIc and Stage IV Malignant Melanoma | 2005-2008 | ClinicalTrials.gov (NCT00289016) |
| ONCOS-102 | Melanoma | A Pilot Study of Sequential ONCOS-102, an Engineered Oncolytic Adenovirus Expressing GMCSF, and Pembrolizumab in Patients with Advanced or Unresectable Melanoma Progressing After Programmed Cell Death Protein 1 (PD1) Blockade | 2016-2020 | ClinicalTrials.gov (NCT03003676) |
| ParvOryx (Oncolytic virus) | Pancreatic Cancer | A non-controlled, single arm, open label, Phase II study of intravenous and intratumoral administration of ParvOryx in patients with metastatic, inoperable pancreatic cancer | 2015-2018 | EudraCT [b] (2015-001119-11) |
| ParvOryx (Oncolytic virus) | Glioblastoma | Phase I/IIa study of intratumoral/intracerebral or intravenous/intracerebral administration of PArvovirus H-1 (ParvOryx) in patients with progressive primary or recurrent glioblastoma multiforme | 2011-2015 | EudraCT (2011-000572-33) |
| HSV1716 (Oncolytic virus) | Pleural mesothelioma | A Phase I/IIa Study Of The Safety, Tolerability And Biological Effect Of Single And Repeat Administration Of The Selectively Replication-Competent Herpes Simplex Virus Hsv1716 Into The Tumour-Bearing Pleural Cavity (Intrapleural) In Patients With Inoperable Malignant Pleural Mesothelioma. | 2012-2016 | EudraCT (2010-024496-37) |
| Pexa-Vec (Oncolytic virus) | Hepatocellular carcinoma | A phase I/IIa trial to evaluate the safety and efficacy of the combination of the oncolytic immunotherapy Pexa-Vec with the PD-1 receptor blocking antibody nivolumab in the first-line treatment of advanced hepatocellular carcinoma (HCC) | 2018-2020 | EudraCT (2016-000085-32) |
| ONCOS-102 (Oncolytic virus) | Pleural mesothelioma | A randomised Phase II open-label study with a Phase Ib safety lead-in cohort of ONCOS-102, an immune-priming GM-CSF coding oncolytic adenovirus, and pemetrexed/cisplatin in patients with unresectable malignant pleural mesothelioma | 2018-2019 | EudraCT (2015-005143-13) |
| T-VEC (Oncolytic virus) | Melanoma | A Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety and Efficacy of Talimogene Laherparepvec and Ipilimumab Compared to Ipilimumab Alone in Subjects With Unresected, Stage IIIB-IV Melanoma | 2014-2021 | EudraCT (2012-000307-32) |
| VNP20009 (Bacteria) | Cancer | Treatment of Patients With Cancer With Genetically Modified Salmonella Typhimurium Bacteria | 2000-2002 | ClinicalTrials.gov (NCT00004988) |
| Lactobacillus plantarum HEAL 19 (Bacteria) | Rectal Cancer | Action of Synbiotics on Irradiated GI Mucosa in Rectal Cancer Treatment | 2008-2015 | ClinicalTrials.gov (NCT03420443) |
| Intestine bacteria | Breast Cancer | Intestine Bacteria and Breast Cancer Risk | 2011-2020 | ClinicalTrials.gov (NCT01461070) |
| Gut bacteria | Breast Cancer | Engineering Gut Microbiome to Target Breast Cancer | 2017-2020 | ClinicalTrials.gov (NCT03358511) |
| Gut bacteria | Colorectal cancer | Study of Fecal Bacteria in Early Diagnosis of Colorectal Cancer | 2012-2017 | ClinicalTrials.gov (NCT02845973) |
| Bacteria vaccine | Cancer | A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients with Tumors Expressing NY-ESO-1 Antigen | 2007-2013 | ClinicalTrials.gov (NCT00623831) |
| C. novyi-NT (Bacteria) | Solid Tumor | Safety Study of Intratumoral Injection of Clostridium Novyi-NT Spores to Treat Patients With Solid Tumors That Have Not Responded to Standard Therapies | 2013-2017 | ClinicalTrials.gov (NCT01924689) |
| Colistimethate sodium (Bacteria) | Haematological Malignancies | A Study of DEcolonization in Patients with HAematological Malignancies (DEHAM) | 2017-2017 | ClinicalTrials.gov (NCT02966457) |
| Bacteria | Malignant Neoplasm | Peritoneal Bacterial Contamination Following Resection With Closed or Open Rectal Stump for Left-sided Cancer | 2014-2014 | ClinicalTrials.gov (NCT02527382) |
| Bacteria | Breast Cancer | Effects of Chemotherapy on Intestinal Bacteria in Patients With Newly Diagnosed Breast Cancer | 2014-2018 | ClinicalTrials.gov (NCT02370277) |
| AG013 (Bacteria) | Head and Neck Cancer | Study to Assess Safety and Tolerability of AG013 in Oral Mucositis in Subjects Receiving Induction Chemotherapy for the Treatment of Cancers of the Head and Neck | 2009-2012 | ClinicalTrials.gov (NCT00938080) |
| Oral bacteria | Pancreatic Cancer | Oral Microbiome and Pancreatic Cancer | 1992-2010 | ClinicalTrials.gov (NCT03302637) |
| La1, BB536 (Bacteria) | Colorectal Cancer | Probiotics In Colorectal Cancer Patients | 2006-2007 | ClinicalTrials.gov (NCT00936572) |
| Bl-04, NCFM (Bacteria) | Colon cancer | Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer | 2010-2016 | ClinicalTrials.gov (NCT03072641) |
| JNJ-64041809 (Bacteria) | Prostate Cancer | Safety & Immunogenicity of JNJ-64041809, a Live Attenuated Double-deleted Listeria Immunotherapy, in Participants With Metastatic Castration-resistant Prostate Cancer | 2015-2018 | ClinicalTrials.gov (NCT02625857) |
| Bacteria | Leukemia; Sarcoma; Neuroblastoma | The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients | 2007-2017 | ClinicalTrials.gov (NCT00726934) |
| Bacteria | Skin Cancer | Observational Study to Investigate Surgical Site Infection in Ulcerated Skin Cancers | 2019-2020 | ClinicalTrials.gov (NCT03782727) |
| Bacteria | Gastric Cancer | Gastric Cancer Precursor Lesions (GCPL) Study | 2017-2020 | ClinicalTrials.gov (NCT03188406) |
| Intestinal microbiome | Gastric Cancer | Intestinal Microbiome After Gastrectomy | 2018-2019 | ClinicalTrials.gov (NCT03418428) |
| Bacteria | Colorectal cancer, Stomach cancer, Pancreatic Cancer | Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery | 2008-2012 | ClinicalTrials.gov (NCT04002128) |
| Bacteria | Colorectal cancer | Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer | 2010-2015 | ClinicalTrials.gov (NCT01479907) |
| Bacteria | Colorectal Cancer | Microbiota-anastomotic Leak Among Colorectal Surgery Patients: Pilot Study | 2018-2018 | ClinicalTrials.gov (NCT03496441) |
| Fluoroquinolone Resistant Enteric Bacteria | Prostate cancer | Incidence of Fluoroquinolone Resistant Bacteria in Patients Undergoing Prostate Biopsy | 2015-2016 | ClinicalTrials.gov (NCT02140502) |
| Fecal Microbiota | Leukemia | PreventiOn of DYSbioSis Complications With Autologous FMT in AML Patients | 2016-2018 | ClinicalTrials.gov (NCT02928523) |
| Gut microbiome | Colorectal Adenoma | Ginger and Gut Microbiome | 2018-2020 | ClinicalTrials.gov (NCT03268655) |
| Probiotics (Bacteria) | Hepatocellular Carcinoma | Influence of Probiotics Administration Before Liver Resection in Liver Disease | 2013-2018 | ClinicalTrials.gov (NCT02021253) |
| BCG (Bacteria) | Bladder cancer | A Phase III Randomized, Open-Label, Multi-Center, Global Study of Durvalumab and Bacillus Calmette-Guerin (BCG) Administered as Combination Therapy Versus BCG Alone in High-Risk, BCG Naïve Non Muscle Invasive Bladder Cancer Patients | 2017-2019 | EudraCT (2017-002979-26) |
a) ClinicalTrials.gov (https://clinicaltrials.gov/); b) EudraCT (https://www.clinicaltrialsregister.eu)