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



Status:Terminated
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/20/2018
Start Date:November 2014
End Date:October 3, 2018

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A Phase 2 Study of Glembatumumab Vedotin, an Anti-gpNMB Antibody-drug Conjugate, as Monotherapy or in Combination With Immunotherapies in Patients With Advanced Melanoma

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

Glembatumumab vedotin consists of an antibody attached to a drug, monomethyl auristatin E
(MMAE), that can kill cancer cells. The fully human antibody is designed to deliver the drug
to cancer cells by attaching to a protein called glycoprotein NMB (gpNMB) that is expressed
on the cancer cell. The MMAE is then released inside of the cell, where it interferes with
cell growth and can lead to cell death of the targeted cell, as well as neighboring cells.
Varlilumab is a fully human antibody that binds to CD27. This antibody allows the body's
immune system to work against cancer cells. Nivolumab is a fully human antibody and
pembrolizumab is a humanized antibody. Both bind to PD-1. CDX-301 is a fully human protein
that helps boost production of certain white blood cells. This protein allows the body's
immune system to work against tumor cells.

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.

Inclusion Criteria:

Among other criteria, patients must meet all of the following conditions to be eligible for
the study:

- 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:

Among other criteria, patients who meet any of the following conditions are NOT eligible
for the study:

- 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)
We found this trial at
14
sites
2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Principal Investigator: Douglas B. Johnson, MD
Phone: 800-811-8480
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
Principal Investigator: Lowell Hart, MD
Phone: 877-691-7274
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Fort Myers, FL
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Atlanta, Georgia 30341
Principal Investigator: Aaron Alizadeh, MD
Phone: 770-496-9418
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Atlanta, GA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Patrick Ott, MD
Phone: 617-582-5030
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Chicago, Illinois 60637
Principal Investigator: Jason J Luke, MD
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Dallas, Texas 75246
Principal Investigator: Lance Cowey, MD
Phone: 214-818-8472
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: April Salama, MD
Phone: 919-668-3771
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Los Angeles, California 90025
Principal Investigator: Omid Hamid, MD
Phone: 310-231-2121
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Los Angeles, CA
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Miami Beach, Florida 33140
Principal Investigator: Jose Lutzky, MD
Phone: 305-674-2625
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Miami Beach, FL
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: David Spigel, MD
Phone: 877-691-7274
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Anna Pavlick, DO
Phone: 212-731-5682
New York University School of Medicine NYU School of Medicine has a proud history that...
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San Francisco, California 94117
Principal Investigator: Robert Weber, MD
Phone: 415-750-5660
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West Palm Beach, Florida 33401
Principal Investigator: Neal Rothschild, MD
Phone: 877-691-7274
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