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. Author manuscript; available in PMC: 2022 Apr 3.
Published in final edited form as: Am J Clin Dermatol. 2017 Feb;18(1):1–15. doi: 10.1007/s40257-016-0238-9

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