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Brief Title: A Study of Combination With TBI-1401(HF10) and Ipilimumab in Japanese Patients With Unresectable or Metastatic Melanoma
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
Study ID: NCT03153085
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Clinical Site, Nagakute, Aichi, Japan
Clinical Site, Nagoya, Aichi, Japan
Clinical Site, Kurume, Fukuoka, Japan
Clinical Site, Sapporo, Hokkaido, Japan
Clinical Site, Tsukuba, Ibaraki, Japan
Clinical Site, Chūōku, Tokyo, Japan
Clinical Site, Chūō, Yamanashi, Japan
Clinical Site, Fukuoka, , Japan
Clinical Site, Kumamoto, , Japan
Clinical Site, Niigata, , Japan
Clinical Site, Shizuoka, , Japan
Clinical Site, Ōsaka, , Japan
Name: Naoya Yamazaki
Affiliation: National Cancer Center Hospital
Role: PRINCIPAL_INVESTIGATOR