Table 3.
TVEC Clinical Trials in Melanoma.
Therapy | Phase (Enrollment) | Primary Outcomes |
---|---|---|
TVEC Monotherapy | I (n = 30) | Established dosing regimen |
TVEC Monotherapy | II (n = 50) | ORR = 26%, CR = 16% |
TVEC v. GM-CSF | III (n = 436) | TVEC improved DRR v. GM-CSF (16% v. 2%, p < 0.001) |
Neoadjuvant TVEC v. Immediate Resection | II (n = 150) | Enrollment completed May 2017, results pending |
Ipilimumab +/− TVEC | Ib/II (n = 198) | Addition of TVEC to Ipilimumab improved ORR (39% v. 18%, p = 0.002) |
Pembrolizumab +/− TVEC | Ib/III (n = 660) | Ib (n = 21) demonstrated tolerability and ORR = 57% with combo; phase III enrolling |
TVEC + Dabrafenib and Trametinib | Ib (n = 20) | Enrolling |