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
- glembatumumab vedotin — DRUG
- glembatumumab vedotin and varlilumab — DRUG
- glembatumumab vedotin and PD-1 targeted checkpoint inhibitor (nivolumab OR pembrolizumab) — DRUG
- glembatumumab vedotin and CDX-301 — DRUG
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 vedotinglembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle.
- Experimental: Glembatumumab vedotin and varlilumabglembatumumab 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 inhibitorglembatumumab 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-301glembatumumab 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Angeles Clinic and Research Institute | Los Angeles | California | 90025 | - |
| Northern California Melanoma Center/St. Mary's Medical Center | San Francisco | California | 94117 | - |
| Florida Cancer Specialists | Fort Myers | Florida | 33916 | - |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | - |
| Florida Cancer Specialists | West Palm Beach | Florida | 33407 | - |
| Northside Hospital Cancer Institute | Atlanta | Georgia | 30341 | - |
| University of Chicago Medicine | Chicago | Illinois | 60637 | - |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | - |
| Henry Ford Hospital | Detroit | Michigan | 48202 | - |
| New York University School of Medicine | New York | New York | 10016 | - |
| Duke University Medical Center | Durham | North Carolina | 27710 | - |
| Tennessee Oncology | Nashville | Tennessee | 37203 | - |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | - |
| Baylor Research Institute-Sammons Cancer Center | Dallas | Texas | 75246 | - |
Find similar trials in Los Angeles, CA
By condition
By specialty
By research site
The Angeles Clinic and Research Institute· Los Angeles, CANorthern California Melanoma Center/St. Mary's Medical Center· San Francisco, CAFlorida Cancer Specialists· Fort Myers, FLMount Sinai Comprehensive Cancer Center· Miami Beach, FLFlorida Cancer Specialists· West Palm Beach, FLNorthside Hospital Cancer Institute· Atlanta, GA
Related Studies
- Storage and Research Use of Human Bio-specimens From Melanoma Patients and Clinical Testing for Assignment of TreatmentRecruiting · Vanderbilt-Ingram Cancer Center · Nashville, Tennessee
- Molecular Testing for the MD Anderson Cancer Center Personalized Cancer Therapy ProgramRecruiting · M.D. Anderson Cancer Center · Houston, Texas
- Integrated Cancer Repository for Cancer ResearchRecruiting · University of Nebraska · Greenwood Village, Colorado
- A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)PHASE1/PHASE2 · Recruiting · Merck Sharp & Dohme LLC · Aurora, Colorado