A Study of Combination with TBI-1401(HF10) and Ipilimumab in Japanese Patients with Unresectable or Metastatic Melanoma

Sponsor
Takara Bio Inc.
Study ID
NCT03153085
Phase
PHASE2
Status
Completed

Conditions

  • Melanoma Stage III
  • Melanoma Stage IV

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TBI-1401(HF10) — BIOLOGICAL
    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.
  • Ipilimumab — DRUG
    3 mg/kg ipilimumab (for a total of 4 intravenous infusions, each administered at 3-week intervals).

Study Details

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.

Key Dates

Start date
May 25, 2017
Status verified
Dec 2024
Primary completion
Jun 30, 2018
Completion
Dec 14, 2018

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TBI-1401(HF10) + Ipilimumab
    1x10\^7 TCID50/mL TBI-1401(HF10) administered to a single or multiple eligible tumors in a total volume up to 5.0 mL (injection volume will be adjusted based on the size of tumor mass) by intratumoral injection and 3 mg/kg ipilimumab administered by intravenous infusions.

Primary Outcome Measure

Best overall response rate (BORR) by irRC [ Time Frame: at 24 weeks ]

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