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

PHASE2CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

May 25, 2017

Primary Completion Date

June 30, 2018

Study Completion Date

December 14, 2018

Conditions
Melanoma Stage IIIMelanoma Stage IV
Interventions
BIOLOGICAL

TBI-1401(HF10)

"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."

DRUG

Ipilimumab

3 mg/kg ipilimumab (for a total of 4 intravenous infusions, each administered at 3-week intervals).

Trial Locations (12)

Unknown

Clinical Site, Nagakute

Clinical Site, Nagoya

Clinical Site, Fukuoka

Clinical Site, Kurume

Clinical Site, Sapporo

Clinical Site, Tsukuba

Clinical Site, Kumamoto

Clinical Site, Niigata

Clinical Site, Osaka

Clinical Site, Shizuoka

Clinical Site, Chūōku

Clinical Site, Chūō

All Listed Sponsors
lead

Takara Bio Inc.

INDUSTRY

NCT03153085 - A Study of Combination with TBI-1401(HF10) and Ipilimumab in Japanese Patients with Unresectable or Metastatic Melanoma | Biotech Hunter | Biotech Hunter