Table 3.
Main clinical trials on OV regimens in non-melanoma skin cancers and their reported findings.
| Author, Study Name (NCT#) | Phase (Status) | Therapy (Combination) | N | Study Population |
ORR (%) | Main Outcomes (DoR, PFS, etc. in Months |
TRAE (Most Common Grade 3–4) |
|---|---|---|---|---|---|---|---|
| (NCT03458117) | I (Recruiting) | T-VEC | 20 | SCC | N/A | N/A | N/A |
| (NCT04163952) | I (Recruiting) | T-VEC + Panitumumab | 30 | SCC | N/A | N/A | N/A |
| (NCT04050436) | II (Recruiting) | RP1 + Cemiplimab vs. Cemiplimab | 180 | SCC | N/A | N/A | N/A |
| (NCT03714828) | II (Recruiting) | T-VEC | 28 | SCC | N/A | N/A | N/A |
| (NCT01161498) | III (Terminated) | T-VEC + Radiation + Cisplatin vs. Radiation + Cisplatin | 5 | HNSCC | N/A | N/A | Lung infection, urinary tract infection, hyperglycemia, malignant neoplasm progression, acute renal failure, pleural effusion |
| (NCT04349436) | Ιb (recruiting) | RP1 | 30 | SCC | N/A | N/A | N/A |
| Harrington et al., 2021 (NCT02626000) | Ιb (Completed) | T-VEC + pembrolizumab | 36 | Recurrent or metastatic HNSCC | 16.7 | mDoR = 45.9 months mPFS = 3 months |
Pyrexia, arterial hemorrhage, chills, mucosal hemorrhage |
| (NCT03458117) | I (Recruiting) | T-VEC | 20 | BCC | N/A | N/A | N/A |
| (NCT03458117) | I (Recruiting) | T-VEC | 20 | MCC | N/A | N/A | N/A |
| (NCT02819843) | II (Active, not recruiting) | T-VEC | 19 | MCC | N/A | N/A | N/A |
| (NCT03921073) | II (Active, not recruiting) | T-VEC | 5 | Angiosarcoma of the skin | N/A | N/A | N/A |
| Kelly CM et al., 2020 (NCT03069378) |
II (Recruiting) | T-VEC + pembrolizumab | 20 | Locally advanced/ metastatic sarcoma | 35 | mDoR = 14 months (56.1 weeks) mPFS = 4.3 months (17.1 weeks) |
Pneumonitis, anemia, fever, hypophosphatemia |
Abbreviations: N/A = not available; N = number of patients; ORR = objective response rate; DoR = duration of response; PFS = progression free survival; TRAE = treatment-related adverse events; T-VEC = talimogene laherparepvec; SCC = squamous cell carcinoma; BCC = basal cell carcinoma; MCC = Merkel cell carcinoma; HNSCC = head and neck SCC.