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

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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

      PRIMARY OBJECTIVES:

      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.

      SECONDARY OBJECTIVES:

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

      TERTIARY OBJECTIVES:

      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.

      OUTLINE:

      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

Interventional


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

Condition

Recurrent Uveal Melanoma

Intervention

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.

Publications

* 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

Drug

Estimated Enrollment

37

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
             therapy

          -  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
             required

          -  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
             symplostatin)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Sapna Patel, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02363283

Organization ID

NCI-2015-00159

Secondary IDs

NCI-2015-00159

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

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


Verification Date

July 2020