Glembatumumab Vedotin in Treating Patients With Metastatic or Locally Recurrent Uveal Melanoma

Learn more about:
Related Clinical Trial
A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors Sitravatinib and Tislelizumab in Patients With Metastatic Uveal Melanoma With Liver Metastases. Olaparib in Combination With Pembrolizumab for Advanced Uveal Melanoma Adjuvant Melatonin for Uveal Melanoma Targeted Alpha Particle Radiotherapy for Metastatic Uveal Melanoma Olaparib in Unresectable/Metastatic Melanoma With BRCA1/2 Prospective Registration Of Patient Data and Quality of Life in Eye Melanoma Patients Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists In Patients With Melanoma (Including Ocular Melanoma) The Role of Genetic Mutations and of Circulating mRNAs in Uveal Melanoma A Study of Concurrent Stereotactic Body Radiotherapy With Ipi and Nivo in Metastatic Uveal Melanoma Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal Melanoma Managed Access Program Supporting Patient Access to Tebentafusp Efficacy of Spartalizumab Across Multiple Cancer-types in Patients With PD1-high mRNA Expressing Tumors Frequency and Clinical Phenotype of BAP1 Hereditary Predisposition Syndrome A Study of APG-115 in Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors Early Integration of Supportive Care Into Standard Oncology Care for Metastatic Uveal Melanoma Patients Defactinib (VS-6063) Combined With VS-6766 in Patients With Metastatic Uveal Melanoma Study of PAC-1 and Entrectinib for Patients With Metastatic Uveal Melanoma A Prospective Natural History Study in Uveal Melanoma Uveal Melanoma and Brachytheraphy: Long-term Outcomes. A Study of RO7293583 in Participants With Unresectable Metastatic Tyrosinase Related Protein 1 (TYRP1)-Positive Melanomas Study to Evaluate the Safety of IMM-01 in Patients With Advanced Solid Tumours Isolated Hepatic Perfusion in Combination With Ipilimumab and Nivolumab in Patients With Uveal Melanoma Metastases Study of Safety and Tolerability of BCA101 Alone and in Combination With Pembrolizumab in Patients With EGFR-driven Advanced Solid Tumors Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME) Phase 2 Trial of AU-011 Via Suprachoroidal Administration With a Dose Escalation and Randomized, Masked Dose Expansion Designed to Evaluate Safety and Efficacy of AU-011 in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed by Surgery Epacadostat and Vaccine Therapy in Treating Patients With Stage III-IV Melanoma Sargramostim, Vaccine Therapy, or Sargramostim and Vaccine Therapy in Preventing Disease Recurrence in Patients With Melanoma That Has Been Removed By Surgery A Study of PLX2853 in Advanced Malignancies. Combined PET/CT Imaging for the Early Detection of Ocular Melanoma Metastasis Compared to CT Scanning Alone A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001) TTT Versus TTT and Triamcinolone to Decrease Exudation in Choroidal Melanoma After Proton Beam Therapy C7R-GD2.CART Cells for Patients With Relapsed or Refractory Neuroblastoma and Other GD2 Positive Cancers (GAIL-N) Genetic Predictors of Efficiency and Safety of ICIs in Patients With Different Malignancies (ICIPRESIST-0519) Treatment Of Radiation Retinopathy Trial Temozolomide or Selumetinib in Treating Patients With Metastatic Melanoma of the Eye Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy Ph 1 Study in Subjects With Tumors Requiring Arginine to Assess ADI-PEG 20 With Pemetrexed and Cisplatin Study in Subjects With Small Primary Choroidal Melanoma Study Multicentre Evaluating the Effectiveness and Toxicity Sorafenib (Nexavar®) in Adult Patients With Uveal Melanoma and Metastatic Dissemination Trial of AEB071 in Combination With BYL719 in Patients With Melanoma Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSF Vorinostat in Treating Patients With Metastatic Melanoma of the Eye Radiation Therapy in Preventing Liver Metastases in Patients With Uveal Melanoma Who HaveMonosomy 3 or DecisionDx Class 2 Disease and Are More Likely to Develop Liver Metastases 5 Year Registry Study to Track Clinical Application of DecisionDx-UM Assay Results and Associated Patient Outcomes Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Uveal Melanoma Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma Pembrolizumab in Treating Patients With Advanced Uveal Melanoma Vascular Response to Brachytherapy Using Functional OCT Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma SIR-Spheres® 90Y Microspheres Treatment of Uveal Melanoma Metastasized to Liver Glembatumumab Vedotin in Treating Patients With Metastatic or Locally Recurrent Uveal Melanoma Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal Melanoma Stereotactic Body Radiation Therapy and Aflibercept in Treating Patients With Uveal Melanoma Endoresection of the Tumor Scar or Transpupillary Thermotherapy for the Treatment of Large Uveal Melanomas (Endoresection-Laser) Durvalumab (MEDI4736) Plus Cediranib in Patients With Metastatic Uveal Melanoma A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma Tilting of Radioactive Plaques After Initial Accurate Placement for Treatment of Uveal Melanoma A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma Trametinib With or Without GSK2141795 in Treating Patients With Metastatic Uveal Melanoma RAD001 (Everolimus) and Pasireotide (SOM230) LAR in Patients With Advanced Uveal Melanoma Safety & Activity of Controllable PRAME-TCR Therapy in Previously Treated AML/MDS or Metastatic Uveal Melanoma CAVATAK® and Ipilimumab in Uveal Melanoma Metastatic to the Liver (VLA-024 CLEVER) Comparison Between Fotemustin to Intensive Surveillance in Patients With High Risk Uveal Melanoma Dendritic Cells Plus Autologous Tumor RNA in Uveal Melanoma Study of Immunotherapy Plus ADI-PEG 20 for the Treatment of Advanced Uveal Melanoma New Biopsy Technique for Uveal Melanoma Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Metastatic Uveal Melanoma (SUMIT) Safety and Efficacy of AEB071 in Metastatic Uveal Melanoma Patients Influence of Oral Treatment With Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas With Proton Beam Therapy Intermittent Selumetinib for Uveal Melanoma Transarterial Radioembolisation in Comparison to Transarterial Chemoembolisation in Uveal Melanoma Liver Metastasis A Phase I Study of LXS196 in Patients With Metastatic Uveal Melanoma. Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (ct DNA R0) Messenger Ribonucleic Acid (mRNA) Transfected Dendritic Cell Vaccination in High Risk Uveal Melanoma Patients Study of the Activity of PD-1 Inhibitors in Metastatic Uveal Melanoma A Study of Sorafenib in Patients With Chemonaive Metastatic Uveal Melanoma Crizotinib in High-Risk Uveal Melanoma Following Definitive Therapy Trial of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated Metastatic Uveal Melanoma Vorinostat in Patients With Class 2 High Risk Uveal Melanoma Yttrium90, Ipilimumab, & Nivolumab for Uveal Melanoma With Liver Metastases A Phase II Study of BVD-523 in Metastatic Uveal Melanoma Assessing the Clinical Effectiveness of Serum Biomarkers in the Diagnosis of Metastatic Uveal Melanoma Treatment With Intravitreal Avastin for Large Uveal Melanomas

Brief Title

Glembatumumab Vedotin in Treating Patients With Metastatic or Locally Recurrent Uveal Melanoma

Official Title

A Phase 2 Study of CDX-011 (Glembatumumab Vedotin) for Metastatic Uveal Melanoma

Brief Summary

      This phase II trial studies how well glembatumumab vedotin works in treating patients with
      middle layer of the wall of the eye (uveal) melanoma that has spread to other parts of the
      body (metastatic) or has returned at or near the same place after a period of time during
      which the cancer could not be detected (locally recurrent). Glembatumumab vedotin may shrink
      the tumor by binding to tumor cells and delivering tumor-killing substances to them.

Detailed Description


      I. To characterize the clinical anti-tumor activity of CDX-011 (glembatumumab vedotin) as a
      single-agent in the treatment of patients with metastatic uveal melanoma.


      I. Description of the clinical safety and benefit of CDX-011 (glembatumumab vedotin) and
      pharmacodynamics changes in glycoprotein NMB (glycoprotein [transmembrane] NMB) (GPNMB)


      I. Characterization of the anti-tumor immunophenotype of patients receiving treatment.

      II. Post hoc, correlation of rash with clinical benefit, or lack of rash with lack of
      benefit, will also be explored.


      Patients receive glembatumumab vedotin intravenously (IV) over 90 minutes every 3 weeks in
      the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up for 30 days.

Study Phase

Phase 2

Study Type


Primary Outcome

Overall Response Rate Using Response Evaluation Criteria in Solid Tumors Version 1.1

Secondary Outcome

 The Number of Participants With Change in Glycoprotein NMB Expression on Tumor Tissue Via Immunohistochemistry


Recurrent Uveal Melanoma


Glembatumumab Vedotin

Study Arms / Comparison Groups

 Treatment (glembatumumab vedotin)
Description:  Patients receive glembatumumab vedotin IV over 90 minutes every 3 weeks in the absence of disease progression or unacceptable toxicity.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

September 16, 2015

Completion Date

July 2, 2018

Primary Completion Date

July 2, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed metastatic or locally
             recurrent uveal melanoma; because histologic or cytologic confirmation of primary
             uveal melanoma is not always possible, confirmation of the clinical diagnosis of uveal
             melanoma by the treating investigator is allowed; clinical diagnosis of uveal melanoma
             is often made by an ophthalmologist, not by tissue diagnosis; if an ophthalmologist
             diagnosed and treated a patient for uveal melanoma in the past, it is sufficient for a
             clinical diagnosis

          -  Patients must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (longest diameter to be recorded for
             non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with
             conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT)
             scan, magnetic resonance imaging (MRI), or calipers by clinical exam

          -  The study will be limited to patients who are chemotherapy naive; patients may have
             received prior systemic or liver-directed local therapies for advanced uveal melanoma
             as long as those treatments do not involve chemotherapy; this includes, but is not
             limited to: immunotherapy, targeted therapy, transarterial embolization,
             radiofrequency ablation, or cryoablation; treatment must be completed at least 28 days
             prior to initiation of study therapy; radiation therapy is also allowed and must be
             completed at least 28 days prior to initiation of study therapy; lesions treated via
             radiation or liver-directed therapy may not be used as target lesions unless they
             demonstrate growth over a minimum of 3 months on subsequent imaging

          -  All prior treatment-related toxicities must be Common Terminology Criteria for Adverse
             Events (CTCAE) version (V) 5 grade =< 1 (except alopecia); certain exceptions apply,
             such as immunotherapy-induced hypothyroidism or adrenal insufficiency or
             panhypopituitarism requiring stable doses of hormone replacement or rash from prior

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2

          -  Life expectancy of greater than 3 months

          -  Leukocytes >= 3,000/uL

          -  Absolute neutrophil count >= 1,500/uL

          -  Platelets >= 100,000/uL

          -  Total bilirubin =< 1.5 x institutional upper limit of normal

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 2.5 x institutional upper limit of normal; =< 5 x institutional upper limit of
             normal if liver metastasis present

          -  Creatinine =< institutional upper limit of normal OR creatinine clearance >= 60
             mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry, for
             the duration of study participation, and for 4 months after last CDX-011
             (glembatumumab vedotin) dose; women of child-bearing potential must have a negative
             serum pregnancy test within 14 days prior to start of protocol treatment; should a
             woman become pregnant or suspect she is pregnant while she or her partner is
             participating in this study, she should inform her treating physician immediately; men
             and women treated or enrolled on this protocol must also agree to use adequate
             contraception prior to the study, for the duration of study participation, and 4
             months after completion of glembatumumab vedotin administration

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Patients with a history of another malignancy except for those who have been
             disease-free for 2 years; patients with a history of definitively treated non-melanoma
             skin cancer or squamous cell carcinoma of the cervix are eligible; patients with
             definitively treated in-situ cancers are eligible, regardless of timeframe

          -  Patients with neuropathy > grade 1

          -  Patients who are receiving any other investigational agents; if the patient received a
             previous investigational or other agent or treatment, a washout period of 4 weeks is

          -  Patients receiving any medications or substances that are substrates of cytochrome
             P450 family 3, subfamily A, polypeptide 4 (CYP3A4) will be closely monitored for
             toxicity; as part of the enrollment/informed consent procedures, the patient will be
             counseled on the risk of interactions with other agents, and what to do if new
             medications need to be prescribed or if the patient is considering a new
             over-the-counter medicine or herbal product

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Human immunodeficiency virus (HIV)-positive patients on antiretroviral medications
             that are CYP3A4 substrates will be closely monitored; HIV-positive patients will be
             excluded if they have a cluster of differentiation 4 (CD4) count < 200

          -  Pregnant or nursing women

          -  Patients who have previously received CDX-011 (glembatumumab vedotin) or other
             monomethyl auristatin E (MMAE)-containing agents

          -  Patients with a history of allergic reactions attributed to compounds of similar
             composition to dolastatin or auristatin (e.g. Auristatin PHE, Auristatin PE, and




18 Years - N/A

Accepts Healthy Volunteers



Sapna Patel, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Responsible Party


Study Sponsor

National Cancer Institute (NCI)

Study Sponsor

Sapna Patel, Principal Investigator, University of Texas MD Anderson Cancer Center LAO

Verification Date

July 2020