Ipilimumab With or Without Talimogene Laherparepvec in Unresected Melanoma

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Amgen
Study ID
NCT01740297
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Talimogene laherparepvec — DRUG
    Talimogene laherparepvec administered by intratumoral injection on Day 1 of Week 1, Day 1 of Week 4, then every two weeks thereafter.
  • Ipilimumab — DRUG
    Ipilimumab administered intravenously every 3 weeks for a total of 4 infusions.

Study Details

Phase 1b of the study will evaluate the safety of talimogene laherparepvec in combination with ipilimumab. Phase 2 is a randomized study that will evaluate the safety and efficacy of talimogene laherparepvec in combination with ipilimumab versus ipilumumab alone.

Key Dates

Start date
Feb 7, 2013
Status verified
May 2024
Primary completion
Aug 23, 2016
Completion
Mar 9, 2021

Study Design

Enrollment
217 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b: Talimogene Laherparepvec + Ipilimumab
    Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque-forming units (PFU)/mL injected into 1 or more skin, nodal, or subcutaneous tumors. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks until complete response (CR), all injectable tumors had disappeared, confirmed disease progression per the modified immune-related response criteria (irRC), or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab administered intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).
  • Active Comparator: Phase 2: Ipilimumab
    Participants received ipilimumab 3 mg/kg intravenously every 3 weeks for a total of 4 infusions starting at week 1.
  • Experimental: Phase 2: Talimogene Laherparepvec + Ipilimumab
    Participants received talimogene laherparepvec at an initial dose of 10⁶ PFU/mL injected into 1 or more skin, nodal, or subcutaneous tumors. Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks until CR, all injectable tumors had disappeared, confirmed disease progression per the modified irRC, or intolerance of study treatment, whichever occurred first. Participants also received 3 mg/kg ipilimumab intravenously every 3 weeks for a total of 4 infusions starting at the time of the third dose of talimogene laherparepvec (week 6).

Primary Outcome Measure

Phase 1b: Number of Participants With Dose-limiting Toxicities [ Time Frame: The DLT evaluation period was 6 weeks from the initial administration of ipilimumab (week 6 to 12). ]

Locations (32)

FacilityCityStateZIPSite coordinators
Research SiteTucsonArizona85724-
Research SiteBeverly HillsCalifornia90211-
Research SiteLos AngelesCalifornia90025-
Research SiteLos AngelesCalifornia90089-2211-
Research SiteLos AngelesCalifornia90095-
Research SiteSan FranciscoCalifornia94115-
Research SiteSanta RosaCalifornia95403-
Research SiteAuroraColorado80045-
Research SiteJacksonvilleFlorida32207-
Research SiteJacksonvilleFlorida32224-
Research SiteLakelandFlorida33805-
Research SiteMiamiFlorida33140-
Research SiteChicagoIllinois60612-
Research SiteIndianapolisIndiana46202-
Research SiteIndianapolisIndiana46260-
Research SiteIowa CityIowa52242-
Research SiteLouisvilleKentucky40202-
Research SiteMinneapolisMinnesota55407-
Research SiteSt LouisMissouri63110-
Research SiteMorristownNew Jersey07962-
Research SiteNew BrunswickNew Jersey08903-
Research SiteNew YorkNew York10029-
Research SiteNew YorkNew York10032-
Research SiteChapel HillNorth Carolina27599-
Research SiteCantonOhio44718-
Research SiteCincinnatiOhio45267-
Research SiteCharlestonSouth Carolina29425-
Research SiteNashvilleTennessee37232-
Research SiteHoustonTexas77030-
Research SiteSalt Lake CityUtah84112-
Research SiteRichmondVirginia23298-0037-
Research SiteMilwaukeeWisconsin53226-

Find similar trials in Tucson, AZ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Research Site· Tucson, AZResearch Site· Beverly Hills, CAResearch Site· Los Angeles, CAResearch Site· San Francisco, CAResearch Site· Santa Rosa, CAResearch Site· Aurora, CO

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