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. 2018 Nov 14;7:35. doi: 10.1186/s40169-018-0214-5

Table 2.

Important ongoing clinical trials combining oncolytic vectors and checkpoint inhibitors

Trial identifier Study phase Virus type Virus name Virus dose, schedule Virus route Checkpoint inhibitor Study regimen cancer type
NCT 03004183
STOMP
II Adenovirus ADV/HSV-tk 5x1011 vp, single injection IT Pembrolizumab Virus (Day 0), Valacyclovir (Day1–15), SBRT (Day 2–16, total 30 Gy), CI (starting day 22) Metastatic NSCLC
Metastatic TNBC
NCT 02798406
CAPTIVE/KEYNOTE-192
II Adenovirus DNX-2401 5x108–5x1010 vp, single injection IT Pembrolizumab Virus (Day 0), CI (starting Day 7–9) Glioblastoma, gliosarcoma
NCT 03003676 I Adenovirus ONCOS-102 3 × 1011 vp, multiple injection (× 3) IT Pembrolizumab Cyclophosphadmide priming, Virus (Day 1, 4, 8), CI (starting day 22) Advanced/Unresectable Melanoma Progressing After PD1 Blockade
NCT 03408587
VLA-024 CLEVER
Ib Coxsackie CAVATAK (CVA21) 1 × 109 TCID50, multiple doses IV Ipilimumab Virus (Day 1, 3, 5, 8 then repeat cycle every 21 days for up to 8 cycles) + CI (Day 8, 29, 50, 71) Uveal Melanoma with Liver Metastases
NCT 02565992
VLA-011 CAPRA
I Coxsackie CAVATAK (CVA21) 4.5 × 106 TCID50/kg, multiple injections IT Pembrolizumab Virus (Day 1, 3, 5, 8, then 3 week intervals), CI (starting day 8) Advanced Melanoma
NCT 02824965 I, II Coxsackie CAVATAK (CVA21) 1 × 108–1 × 109 TCID50, multiple injections IT Pembrolizumab Virus (Day 1, 3, 5, 8, 29, 50, 71, 92, 113, 134, 155) + CI (starting day 8) Advanced NSCLC
NCT 03153085 II HSV HF10 (TBI-1401) 1 × 107 TCID50/mL, multiple injections (× 6) IT Ipilimumab Virus (Week 1, 2, 3, 4, 7, 10) + CI (3-week intervals × 4 doses) Unresectable/Metastatic Melanoma in Japanese Patients
NCT 02272855 II HSV HF10 (TBI-1401) 1 × 107 TCID50/mL, multiple injections (× 6) IT Ipilimumab Virus (Week 1, 2, 3, 4, 7, 10) + CI (3-week intervals × 4 doses) Unresectable/Metastatic Melanoma
NCT 03259425 II HSV HF10 (TBI-1401) 1 × 107 TCID50/mL, multiple injections IT Nivolumab Virus (Day 0, 7, 14, 21, 28, 42, 56, 70, 84) + CI (starting day 0, every 2 weeks for 7 doses) Resectable Stage IIIB/C, IV Melanoma
NCT 01740297 Ib, II HSV TVEC (Talimogene Laherparepvec) 106 PFU/mL, multiple injections IT Ipilimumab Virus (Week 1, 4, then every 2 weeks) + CI (Week 1, then every 3 weeks for 4 total doses) Unresected Stage IIIb/IV melanoma
NCT 02263508
Masterkey 265/KEYNOTE-034
Ib, III HSV TVEC (Talimogene Laherparepvec) Multiple injections IT Pembrolizumab Virus (Day 1, then every 2–3 weeks) + CI (starting 2–5 weeks after first viral inoculation) Unresectable Stage IIIb/IV Melanoma
NCT 02626000
Masterkey 232/Keynote-137
Ib, III HSV TVEC (Talimogene Laherparepvec) 106 PFU/mL, multiple injections IT Pembrolizumab Virus (Day 1 and every 3 weeks) + CI (Day 1 and every 3 weeks) Recurrent/Metastatic HNSCC
NCT 02879760 I, II Maraba Virus MG1-MAGEA3 1x1010–3x1011 pfu, multiple doses IV Pembrolizumab Ad/MAGEAE priming, MG1-MAGEA3 (Day 15/18), CI starting day 22 Previously treated NSCLC
NCT 02620423 Ib Reovirus Reolysin (Pelareorep) 4.5 × 1010 TCID50, multiple doses IV Pembrolizumab Virus (Day 1, 2), Chemo: Gemcitabine or Irinotecan or 5-FU/LV (Day 1), CI (starting Day 8) Pancreatic Adenocarcinoma
NCT 03206073 I, II Vaccinia Pexa Vec (Pexastimogene Devacirepvec) 3 × 108–1 × 109 pfu, multiple doses (× 4) IV Durvalumab
Tremelimumab
Virus (Day 1, 2, 16 of cycle 1; Day 2 of cycle 2) + CI (Day 1 of each cycle) Refractory Colorectal Cancer
NCT 02977156
ISI-JX
I Vaccinia Pexa Vec (Pexastimogene Devacirepvec) 1 × 109 pfu, multiple injections IT Ipilimumab Virus (Week 1, 3, 5, 9, 12) + CI (Week 3, 5, 9, 12–IT injection) Metastatic/Advanced Solid Tumors
NCT 03071094 I, IIa Vaccinia Pexa Vec (Pexastimogene Devacirepvec) 1 x 109 pfu, multiple injections IT Nivolumab Virus (Day 1, Day 14, Day 28) + CI (starting day 14) Advanced HCC

VP viral particle, pfu plaque forming unit, TCID tissue culture infective dose, IT intratumoral, IV intravenous, SBRT stereotactic body radiotherapy, CI checkpoint inhibitor, NSCLC non small cell lung cancer, TNBC triple negative breast cancer, HNSCC head and neck squamous cell carcinoma, HCC hepatocellular carcinoma