A Study of Glembatumumab Vedotin as Monotherapy or in Combination With Immunotherapies in Patients With Advanced Melanoma
NCT ID: NCT02302339
Last Updated: 2019-09-06
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
132 participants
INTERVENTIONAL
2014-11-30
2018-10-03
Brief Summary
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Detailed Description
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Eligible patients who enroll in the study will receive treatment with one of the following: glembatumumab vedotin, glembatumumab vedotin and varlilumab, glembatumumab vedotin and CDX-301 or glembatumumab vedotin and either nivolumab OR pembrolizumab.
All patients enrolled in the study will be closely monitored to determine if their cancer is responding to treatment and for any side effects that may occur.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Glembatumumab vedotin
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle.
glembatumumab vedotin
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.
glembatumumab vedotin and varlilumab
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.
glembatumumab vedotin and PD-1 targeted checkpoint inhibitor (nivolumab OR pembrolizumab)
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.
glembatumumab vedotin and CDX-301
Interventions
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glembatumumab vedotin
glembatumumab vedotin and varlilumab
glembatumumab vedotin and PD-1 targeted checkpoint inhibitor (nivolumab OR pembrolizumab)
glembatumumab vedotin and CDX-301
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Unresectable, histologically-confirmed advanced (Stage III or Stage IV) melanoma
* Disease progression during or after the last anticancer therapy received. For Cohort 3, progression must have occurred during the PD-1 targeted CPI (checkpoint inhibitor) treatment and the investigator has deemed it appropriate to continue treatment with the PD-1 targeted CPI beyond confirmed disease progression
* No more than one prior chemotherapy-containing regimen for advanced disease.
* Prior treatments received must include at least one CPI inhibitor (e.g., anti-CTLA-4, PD-1-, PD-L1-targeted immunotherapy) and for patients with a BRAF mutation at least one BRAF- or MEK-targeted therapy, unless patients are not candidates for, or refused, these therapies. For cohort 3, prior treatment received must include a PD-1 targeted CPI administered during the most recent disease progression and for patients with BRAF mutation at least one BRAF- or MEK-targeted therapy when appropriate
* The study site will submit paraffin-embedded tumor tissue obtained from the patient for gpNMB analysis. Patients may require a biopsy if recent tumor tissue is not available. Patients in cohort 2 and 3 must submit a recently obtained biopsy of the skin fold for gpNMB analysis. Patients in Cohort 4 will submit a tumor tissue sample while on study.
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
* Adequate bone marrow, liver and renal function.
Exclusion Criteria
* Previously received glembatumumab vedotin (CR011-vcMMAE, CDX-011) or other MMAE-containing agents
* Treatment with the following therapies before the planned start of study treatment:
1. BRAF or MEK inhibitors within 2 weeks
2. Monoclonal based therapies within 4 weeks except for the PD-1 targeted checkpoint inhibitor in cohort 3
3. Immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) within 2 weeks
4. Chemotherapy within 21 days or at least 5 half-lives (whichever is longer)
5. Investigational therapy within 2 weeks (or at least 5 half-lives, whichever is longer)
* Patients with ocular melanoma
* Neuropathy that is moderate (Grade 2) or worse.
* Cancer that has spread to the brain or spine will be discussed with the study sponsor and may exclude patients from the trial.
* History of another cancer except:
1. Patients with adequately treated and cured non-melanoma skin cancer or in situ cancer
2. Patients with any other cancer from which the patient has been disease-free for ≥ 3 years
* Significant cardiovascular disease
* Previously received varlilumab or any other anti-CD27 mAb (Cohort 2 only)
* Active systemic infection requiring treatment
* Treatment with immunosuppressive medications within 4 weeks or corticosteroids within two weeks
* Patients with interstitial lung disease (Cohort 3 only)
* Patients with active diverticulitis (Cohort 3 only)
* Any non-study vaccination within 4 weeks, or influenza vaccine within 2 weeks, prior to CDX-301 dosing (Cohort 4 only)
18 Years
ALL
No
Sponsors
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Celldex Therapeutics
INDUSTRY
Responsible Party
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Locations
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The Angeles Clinic and Research Institute
Los Angeles, California, United States
Northern California Melanoma Center/St. Mary's Medical Center
San Francisco, California, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Florida Cancer Specialists
West Palm Beach, Florida, United States
Northside Hospital Cancer Institute
Atlanta, Georgia, United States
University of Chicago Medicine
Chicago, Illinois, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
New York University School of Medicine
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Tennessee Oncology
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Baylor Research Institute-Sammons Cancer Center
Dallas, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CDX011-05
Identifier Type: -
Identifier Source: org_study_id
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