Table 1.
Representative Oncolytic Virus Clinical Trials in Progress (as of November 2016
PRIMARY OUTCOME | DRUGS | PI | CONDITION |
---|---|---|---|
Best overall response rate (BORR) [Time Frame: at 24 weeks] [Designated as safety issue: No] | Replication-competent HSV-1 Oncolytic Virus, and Ipilimumab | Robert Andtbacka | Stage IIIB, Stage IIIC, or Stage IV Unresectable or Metastatic Malignant Melanoma |
Maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of JX-594 administered by intravenous (IV) infusion [Time Frame: 4 weeks] [Designated as safety issue: Yes] | Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594) | David Kim, MD | Melanoma Lung Cancer Renal Cell Carcinoma |
Safety and tolerability of two doses of Coxsackievirus A21 administered intratumourally. [Time Frame: Days 1, 3, 6, 8,10, 13, 17, 24, 38, 52, 87] [Designated as safety issue: Yes] | Coxsackievirus A21 | Mark Smithers Damien Thomson |
Stage IV Melanoma |
Number of participants with treatment-related adverse events as defined by CTCAE v4.03. [Time Frame: 2.5 years] [Designated as safety issue: Yes] |
Biological: GL-ONC1 Biological: Eculizumab |
Kaitlyn Kelly | Solid Organ Cancers |
Response rate for injected tumor(s) [Time Frame: Initial response assessment at 6 weeks] [Designated as safety issue: No] |
Biological: JX-594 | James Burke | Melanoma |
Safety and tolerability (CTCAE version 4.0). [Time Frame: up to Week 16] [Designated as safety issue: Yes] Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.0). |
Biological: TBI-1401(HF10) | Naoya Yamazaki | Solid Tumor |
Phase I: Maximum Tolerated Dose (MTD)/Recommended Phase II Dose (RP2D) [Time Frame: Up to 6 months] [Designated as safety issue: Yes] MTD/RP2D of talimogene laherparepvec administered with neoadjuvant paclitaxel-doxorubicin/cyclophosphamide | Biological: Talimogene laherparepvec Drug: Paclitaxel |
Hatem Soliman | Breast Cancer Ductal Carcinoma Invasive Breast Carcinoma Invasive Ductal Breast Carcinoma |
To determine whether intratumoral injection or intravenous infusions of HSV1716 is safe in adolescents and young adults with non-CNS solid tumors. [Time Frame: Dose limiting toxicities will be assessed at 28 days after injection of HSV1716.] [Designated as safety issue: | Biological: HSV1716 | Timothy Cripe | Rhabdomyosarcoma Osteosarcoma Ewing Sarcoma Soft Tissue Sarcoma |
The incidence of dose-limiting toxicities (DLT) of intravenous pembrolizumab in combination with intratumoral CAVATAK will be assessed using CTCAE v. 4.0. [Time Frame: Up to 2 years] [Designated as safety issue: Yes] | Biological: CAVATAK Drug: Pembrolizumab |
Howard L Kaufman | Melanoma |