MELANOMA: Metastatic: BRAFmt: \"20149189\"

Study snapshot

Title: West Cancer Center 20149189
Malignancy: Melanoma, Skin cancer
Stage: Stage 4
Disease setting: Metastatic/Palliative
Line of therapy: Any, provided no prior therapy with T-VEC or combination of dabrafenib/trametinib
Investigational agent: Talimogene laherparepvec (T-VEC)
Drug class: Oncolytic virus
Principal investigator: Ari VanderWalde
Sponsor: West Cancer Center/Amgen
Intervention arm: T-VEC + Dabrafenib + Trametinib
Path: Superficial spreading, nodular, lentigo maligna, acral lentiginous, desmoplastic, mucosal
Randomized: No
ClinicalTrials.gov ID: NCT03088176

Age >18 years at the time of informed consent
Histologically confirmed diagnosis of melanoma
Primary or recurrent Stage IIIB to IV M1c disease for whom surgery is not recommended
Must have an activating BRAF mutation (limited to V600E or V600K mutations if subject is being treated first line, but can include any well-defined BRAF mutation after failure of prior immunotherapy)
Measurable disease per RECIST 1.1
Injectable disease defined as either of the following:
- At least one injectable cutaneous, subcutaneous, or nodal melanoma lesion >10mm in longest diameter
- Multiple injectable melanoma lesions that in aggregate have a longest diameter of >10mm
ECOG Performance Status 0-1
Any number of prior treatment regimens, provided that subject has not previously received T-VEC or combination of dabrafenib/trametinib
No clinically active CNS mets
No active herpes infection or prior complications of herpetic infections
No known HIV, HBV, HCV
No known severe autoimmune disease

Primary: Rate of DLTs; Secondary: PFS, ORR, TTR, DoR, lesion level responses