Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Participants With Advanced Melanoma

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Millennium Pharmaceuticals, Inc.
Study ID
NCT02723006
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • TAK-580 — DRUG
    TAK-580 tablets
  • TAK-202 — DRUG
    TAK-202 infusion
  • vedolizumab — DRUG
    vedolizumab infusion
  • nivolumab — DRUG
    nivolumab infusion
  • ipilimumab — DRUG
    ipilimumab infusion

Study Details

The purpose of this study is to determine the initial safety profile and initial antitumor activity of the combination treatments (immune checkpoint inhibitors \[nivolumab, ipilimumab\] with investigational drugs \[TAK-580, TAK-202 (plozalizumab), vedolizumab\]) in the 3 arms when administered to participants with advanced melanoma.

Key Dates

Start date
Jun 22, 2016
Status verified
Feb 2024
Primary completion
May 11, 2018
Completion
May 11, 2018

Study Design

Enrollment
22 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: TAK-580 + nivolumab
    TAK-580 orally, once weekly along with nivolumab, intravenous, every 2 weeks.
  • Experimental: TAK-202 (plozalizumab) + nivolumab
    TAK-202 (plozalizumab) 2 milligram (mg), intravenous, once in Week 1, 3, 5, 9, and every 4 weeks thereafter with nivolumab infusion, intravenous, every 2 weeks.
  • Experimental: vedolizumab + nivolumab + ipilimumab
    Vedolizumab intravenous, once in Week 1, 3, 5, and 13 along with nivolumab infusion, intravenous, once in Week 1, 4, 7, 10, and 13 and every 2 weeks thereafter, along with ipilimumab intravenous, once in Week 1, 4, 7, and 10.

Primary Outcome Measure

Number of Dose Limiting Toxicities (DLTs) During the Dose-escalation Safety Lead-in Phase [ Time Frame: TAK-580 + Nivolumab and TAK-202 + Nivolumab: Baseline up to Week 9; Vedolizumab + Nivolumab + Ipilimumab: Baseline up to Week 7 ]

Locations (14)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer CenterTucsonArizona--
University of California Los Angeles - Jonsson Comprehensive Cancer CenterLos AngelesCalifornia--
University of California San Francisco Medical CenterSan FranciscoCalifornia--
University of Colorado Cancer CenterAuroraColorado--
Emory University HospitalAtlantaGeorgia--
Dana-Farber Cancer InstituteBostonMassachusetts--
Massachusetts General Hospital Cancer CenterBostonMassachusetts--
Virginia Piper Cancer InstituteMinneapolisMinnesota--
Washington University School of MedicineSt LouisMissouri--
New York University Langone Medical CenterNew YorkNew York--
Saint Luke's Cancer Center - BethlehemEastonPennsylvania--
Fox Chase Cancer CenterPhiladelphiaPennsylvania--
Texas Oncology-Baylor Charles A. Sammons Cancer CenterDallasTexas--
Inova Fairfax HospitalFairfaxVirginia--

Find similar trials in Tucson, AZ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
University of Arizona Cancer Center· Tucson, AZUniversity of California Los Angeles - Jonsson Comprehensive Cancer Center· Los Angeles, CAUniversity of California San Francisco Medical Center· San Francisco, CAUniversity of Colorado Cancer Center· Aurora, COEmory University Hospital· Atlanta, GADana-Farber Cancer Institute· Boston, MA

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