Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma

Completed · Phase 2

Conditions studied: Metastatic Melanoma

In brief

This is a global, Phase 2, open label, dose selection, proof-of-concept study to assess progression free survival in subjects with metastatic melanoma. Approximately 80 subjects at 29 sites in the U.S., U.K., Germany and Australia will be randomized into one of two dose groups: 2 mg/kg, 4 mg/kg. Weekly treatment will continue until disease progression. Subjects must have measurable disease by CT Scan or MRI and must have completed at least one prior round of chemotherapy. Subjects will be assessed for Efficacy, PK/PD, Overall survival, and Safety (Adverse Events/Adverse Events of Interest, Electrocardiograms (ECG's), clinical labs, physical exams/vital signs, tolerability).

Key facts

Study ID

NCT01335009

Run by

Eisai Inc.

People needed

76

Starts

2011-05-16

Expected to finish

2020-04-10

Last updated by the study team

2021-09-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period.
• Histologically confirmed diagnosis of metastatic melanoma
• At least 1 prior systemic treatment for metastatic melanoma with disease progression following treatment
• Measurable disease, as defined by RECIST v1.1, assessed within 4 weeks prior to study entry
• At least 3 week interval between first infusion of test article and most recent prior systemic anticancer therapy. All treatment-associated toxicity must be resolved to less than or equal to Grade 1 before the administration of MORAb-004
• Have a life expectancy of at least 3 months as estimated by the investigator
• Have other significant medical conditions well-controlled and stable, in the opinion of the investigator, for at least 30 days prior to Study Day 1
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Have sites of disease amenable to the protocol-specified biopsy (Note: All participants will have protocol-specified biopsy at Screening. The second, on-treatment biopsy will be mandatory in the first 30 randomized participants only. For all other participants, the second biopsy is optional.
• Laboratory tests results prior to Study Day 1 within limits as outlined in protocol

You may not qualify if…

• Have received no prior systemic treatment for metastatic melanoma
• Evidence of other active malignancy requiring treatment within the last 5 years (other than basal cell or squamous cell carcinoma of the skin), or active brain metastasis
• Clinically significant heart disease (Congestive heart failure of New York Heart Association [NYHA] Class 3 or 4, angina not well controlled by medication, or myocardial infarction within 6 mos.), or ECGs demonstrating clinically significant arrhythmias
• Have any other serious systemic disease, including active bacterial or fungal infection, or any medical condition requiring cytotoxic therapy or chronic (at least 4 consecutive weeks) systemic corticosteroid use
• Have active viral hepatitis or symptomatic Human immunodeficiency virus (HIV) infection
• Be breast-feeding, pregnant, or likely to become pregnant during the study
• Known allergic reaction to a prior monoclonal antibody therapy
• Previous treatment with MORAb-004
• Brain metastasis

Where it is running

• Pinnacle Oncology — Scottsdale, Arizona, United States
• The Angeles Clinic and Research Institute — Los Angeles, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• University of Colorado Cancer Center, Anschutz Cancer Pavilion — Aurora, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• The University Of Chicago — Chicago, Illinois, United States
• Oncology Specialists, SC — Park Ridge, Illinois, United States
• University of Iowa Hospital — Iowa City, Iowa, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Atlantic Health — Morristown, New Jersey, United States
• New York University Cancer Institute — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• St. Luke's Hospital & Health Network — Bethlehem, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Cancer Institute — Pittsburgh, Pennsylvania, United States
• University of Utah Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Sydney Cancer Center - Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
• Newcastle Melanoma Unit, Calvery Mater Newcastle — Waratah, New South Wales, Australia
• The Crown Princess Mary Cancer Centre, Westmead Hospital — Westmead, New South Wales, Australia
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• Universitatsklinikum Essen, Klinik fur Dermatologie — Essen, Germany

Full record on ClinicalTrials.gov

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