A Study of Combination Treatment With HF10 and Ipilimumab in Patients With Unresectable or Metastatic Melanoma
NCT02272855 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2018-09-26
Summary
The purpose of this study is to determine if HF10 in combination with ipilimumab is effective in patients with stages IIIB, IIIC, or IV unresectable or metastatic melanoma.
Conditions
- Malignant Melanoma
Interventions
- BIOLOGICAL
-
HF10 plus Ipilimumab
Patients will receive the dose of 1 x 10\^7 TCID50/mL HF10 (for a total of 6 injections; the first 4 injections at 1-week intervals; the remaining 2 injections at 3-week intervals) and ipilimumab at 3 mg/kg ipilimumab (for a total of 4 intravenous infusions, each administered at 3-week intervals).
Sponsors & Collaborators
-
Theradex
collaborator INDUSTRY -
Takara Bio Inc.
lead INDUSTRY
Principal Investigators
-
Robert Andtbacka · University of Utah
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-04-30
- Primary Completion
- 2016-10-31
- Completion
- 2018-08-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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