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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
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). 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 eligible for administration.
3 mg/kg ipilimumab (for a total of 4 intravenous infusions, each administered at 3-week intervals).
Clinical Site
Nagakute, Aichi-ken, Japan
Clinical Site
Nagoya, Aichi-ken, Japan
Clinical Site
Fukuoka, Fukuoka, Japan
Clinical Site
Kurume, Fukuoka, Japan
Best overall response rate (BORR) by irRC
Determine the efficacy of TBI-1401(HF10) in combination with Ipilimumab evaluated by irRC (immuno-related response criteria)
Time frame: at 24 weeks
Best overall response rate (BORR) by mWHO response criteria
Determine the efficacy of TBI-1401(HF10) in combination with Ipilimumab evaluated by modified WHO (mWHO) response criteria
Time frame: at weeks 24
Best overall response rate (BORR) by RECIST version 1.1
Determine the efficacy of TBI-1401(HF10) in combination with Ipilimumab evaluated by RECIST version 1.1
Time frame: at weeks 24
Objective response rate (ORR) by irRC
Overall tumor response evaluated by irRC in the measurable target lesion(s) and unmeasurable/evaluable target lesion(s).
Time frame: at weeks 6, 12, 18, and 24
Objective response rate (ORR) by mWHO
Overall tumor response evaluated by mWHO response criteria in the measurable target lesion(s) and unmeasurable/evaluable target lesion(s).
Time frame: at weeks 6, 12, 18, and 24
Objective response rate (ORR) by RECIST version 1.1
Overall tumor response evaluated by RECIST version 1.1 in the measurable target lesion(s) and unmeasurable/evaluable target lesion(s).
Time frame: at weeks 6, 12, 18, and 24
Adverse event summaries, vital signs, and laboratory parameters to evaluate the safety and tolerability.
Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.0).
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Clinical Site
Sapporo, Hokkaido, Japan
Clinical Site
Tsukuba, Ibaraki, Japan
Clinical Site
Kumamoto, Kumamoto, Japan
Clinical Site
Niigata, Niigata, Japan
Clinical Site
Osaka, Osaka, Japan
Clinical Site
Shizuoka, Shizuoka, Japan
...and 2 more locations
Time frame: through study completion, up to 1 year
Progression-free survival (PFS)
Evaluation the time to progression during and after the treatment.
Time frame: through disease progression, up to 3 years
Durable response rate (DRR)
Evaluation the length of time after a partial or complete response.
Time frame: for 1 year
1 year survival rate
Determine the 1 year survival rate of patient who received treatment.
Time frame: at 1 year