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 — BIOLOGICAL
    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).

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)

FacilityCityStateZIPSite coordinators
Clinical SiteSan FranciscoCalifornia94115-
Clinical SiteAtlantaGeorgia30322-
Clinical SitePortlandOregon97239-
Clinical SiteBethlehemPennsylvania18015-
Clinical SiteHersheyPennsylvania17033-
Clinical SiteDallasTexas75230-
Clinical SiteHoustonTexas77030-
Clinical SiteSalt Lake CityUtah84112-

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