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

NCT03153085 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-12-09

No results posted yet for this study

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.

Conditions

  • Melanoma Stage III
  • Melanoma 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).

Sponsors & Collaborators

  • Takara Bio Inc.

    lead INDUSTRY

Principal Investigators

  • Naoya Yamazaki · National Cancer Center Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-25
Primary Completion
2018-06-30
Completion
2018-12-14

Countries

  • Japan

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03153085 on ClinicalTrials.gov