Melanoma Stage IV Clinical Trial
Official title:
A Phase II Study of Combination Treatment With TBI-1401(HF10), a Replication-competent HSV-1 Oncolytic Virus, and Ipilimumab in Japanese Patients With Stage IIIB, IIIC, or IV Unresectable or Metastatic Malignant Melanoma
The purpose of this study is to determine if TBI-1401(HF10) in combination with ipilimumab is effective in Japanese patients with stages IIIB, IIIC, or IV unresectable or metastatic melanoma.
The study is designed to assess efficacy and safety with repeated administration of
intratumoral injections of TBI-1401(HF10) at 1x10^7 TCID50/mL in combination with intravenous
infusions of 3mg/kg ipilimumab in Japanese patients.
This is a single arm, open label Phase II study, to evaluate the efficacy and safety of
TBI-1401(HF10) treatment in combination with the immunologic checkpoint inhibitor, ipilimumab
(anti-CTLA-4 monoclonal antibody). The study population will include patients with Stage
IIIB, IIIC or IV unresectable or metastatic malignant melanoma who are ipilimumab-eligible.
Patients will receive the dose of 1x10^7 TCID50/mL TBI-1401(HF10) (for a total of 6
injections; the first 4 injections at 1-week intervals; the remaining 2 injections at 3-week
intervals) + ipilimumab at 3 mg/kg (for a total of 4 intravenous infusions, each administered
at 3-week intervals).
Following combination therapy, patients may continue to receive the 1x10^7 TCID50/mL
TBI-1401(HF10) alone for up to an additional 13 injections (total of 19 injections = 1 year)
if they have tolerated the study treatment, are responding, have stable disease, or have
progressive disease that is not clinically significant in the judgment of the Investigator.
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