A Study of Glembatumumab Vedotin as Monotherapy or in Combination With Immunotherapies in Patients With Advanced Melanoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Celldex Therapeutics
Study ID
NCT02302339
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

Study Details

This study will examine the effectiveness and safety of glembatumumab vedotin as monotherapy or in combination with immunotherapies in patients with advanced melanoma.

Key Dates

Start date
Nov 30, 2014
Status verified
Aug 2019
Primary completion
Jun 14, 2018
Completion
Oct 3, 2018

Study Design

Enrollment
132 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Glembatumumab vedotin
    glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle.
  • Experimental: Glembatumumab vedotin and varlilumab
    glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Varlilumab administered as an intravenous infusion on Day 1 of cycles 1, 2, 4, 6, 8 and 10.
  • Experimental: Glembatumumab vedotin and PD-1 targeted checkpoint inhibitor
    glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Nivolumab OR pembrolizumab administered according to institutional standard of care.
  • Experimental: Glembatumumab vedotin and CDX-301
    glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. CDX-301 is injected once a day for five days before cycles 1 and 2.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Every 6 to 9 weeks following treatment initiation until disease progression. ]

Locations (14)

FacilityCityStateZIPSite coordinators
The Angeles Clinic and Research InstituteLos AngelesCalifornia90025-
Northern California Melanoma Center/St. Mary's Medical CenterSan FranciscoCalifornia94117-
Florida Cancer SpecialistsFort MyersFlorida33916-
Mount Sinai Comprehensive Cancer CenterMiami BeachFlorida33140-
Florida Cancer SpecialistsWest Palm BeachFlorida33407-
Northside Hospital Cancer InstituteAtlantaGeorgia30341-
University of Chicago MedicineChicagoIllinois60637-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Henry Ford HospitalDetroitMichigan48202-
New York University School of MedicineNew YorkNew York10016-
Duke University Medical CenterDurhamNorth Carolina27710-
Tennessee OncologyNashvilleTennessee37203-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
Baylor Research Institute-Sammons Cancer CenterDallasTexas75246-

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