A Study of Combination Treatment With HF10 and Ipilimumab in Patients With Unresectable or Metastatic Melanoma
Part of paid clinical trials in San Francisco, California.
- Sponsor
- Takara Bio Inc.
- Study ID
- NCT02272855
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- HF10 plus Ipilimumab — BIOLOGICALPatients 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).
Study Details
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.
Key Dates
- Start date
- Apr 30, 2014
- Status verified
- Sep 2018
- Primary completion
- Oct 31, 2016
- Completion
- Aug 31, 2018
Study Design
- Enrollment
- 46 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: HF10 plus ipilimumab
Primary Outcome Measure
Best overall response rate (BORR) [ Time Frame: at 24 weeks ]
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Clinical Site | San Francisco | California | 94115 | - |
| Clinical Site | Atlanta | Georgia | 30322 | - |
| Clinical Site | Portland | Oregon | 97239 | - |
| Clinical Site | Bethlehem | Pennsylvania | 18015 | - |
| Clinical Site | Hershey | Pennsylvania | 17033 | - |
| Clinical Site | Dallas | Texas | 75230 | - |
| Clinical Site | Houston | Texas | 77030 | - |
| Clinical Site | Salt Lake City | Utah | 84112 | - |
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