MELANOMA: Metastatic: BRAFmt: \"20149189\"

A Phase 1b trial of talimogene laherparepvec in combination with dabrafenib and trametinib in advanced melanoma with an activating BRAF mutation

Title
West Cancer Center 20149189
Study Title

A Phase 1b trial of talimogene laherparepvec in combination with dabrafenib and trametinib in advanced melanoma with an activating BRAF mutation

Site Link
Malignancy
Melanoma, Skin cancer
Stage
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
PI
Ari VanderWalde
Sponsor
West Cancer Center/Amgen
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • 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
Objective

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

Assessment Frequency
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Assessment Frequency 2
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Assessment Frequency Link
Path
Superficial spreading, nodular, lentigo maligna, acral lentiginous, desmoplastic, mucosal
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X