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

NCT01335009 | Completed Phase 2 Results

• 2 other identifiers: MORAb-004-201MEL2011-001282-40
• Study Type: interventional
• Target: 76
• Locations: 4 countries
• Sites: 29

Brief Summary

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).

Conditions

Metastatic Melanoma

Keywords

melanoma; malignant; metastatic

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Progression-free Survival (PFS) at Week 24

  PFS was defined as the time (in weeks) from the date of randomization to the date of the first sign of disease progression (PD) based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, or date of death, regardless of cause. PD greater than or equal to (\>=) 20 percent (%) increase in the nadir of total tumor burden (TTB) (minimum 5 millimeter \[mm\]). Participants who were alive with no disease progression had their PFS time censored at the date of their last tumor assessment. Participants who received a new anti-cancer therapy before disease progression had their PFS time censored at the date of their last tumor assessment before the new anti-cancer therapy was started. PFS was analyzed using Kaplan Meier method.

  Week 24

Secondary Outcomes (4)

• Percentage of Participants With PFS at Weeks 16 and 52

  Week 16 and Week 52

• Overall Survival (OS)

  Date of first study treatment (Day 1) to date of death or up to approximately 2 years 7 months

• Percentage of Participants With Overall Response

  Date of first study treatment (Day 1) to complete response or partial response, assessed up to approximately 2 years 7 months

• Optimal Biologic Dosing (OBD) of Morab-004

  Day 1 Cycle 1 (Cycle length = 28 days)

Study Arms (2)

MORAb-004, 2 mg/kg

EXPERIMENTAL

Biologic (monoclonal antibody)

Biological: MORAb-004 (monoclonal antibody)

MORAb-004, 4 mg/kg

EXPERIMENTAL

Biologic (monoclonal antibody)

Biological: MORAb-004 (monoclonal antibody)

Interventions

MORAb-004 (monoclonal antibody) BIOLOGICAL

Subjects will receive one cycle of treatment with MORAb-004, administered intravenously, on Days 1, 8, 15, and 22 (4 administrations per cycle). Additional cycles will continue without interruption until disease progression occurs or clinical or symptomatic progression as suggested by an investigator.

MORAb-004, 2 mg/kg; MORAb-004, 4 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (29)

Pinnacle Oncology

Scottsdale, Arizona, 19454, United States

Location

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

University of Colorado Cancer Center, Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

The University Of Chicago

Chicago, Illinois, 60637, United States

Location

Oncology Specialists, SC

Park Ridge, Illinois, 60068, United States

Location

University of Iowa Hospital

Iowa City, Iowa, 52242, United States

Location

University of Minnesota

Minneapolis, Minnesota, 19454, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Atlantic Health

Morristown, New Jersey, 07962, United States

Location

New York University Cancer Institute

New York, New York, 10016, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 19454, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

St. Luke's Hospital & Health Network

Bethlehem, Pennsylvania, 18051, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Sydney Cancer Center - Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Newcastle Melanoma Unit, Calvery Mater Newcastle

Waratah, New South Wales, 2298, Australia

Location

The Crown Princess Mary Cancer Centre, Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Universitatsklinikum Essen, Klinik fur Dermatologie

Essen, 45147, Germany

Location

Universitats-Hautklinik

Mainz, 55131, Germany

Location

Eberhard Karls University Tuebingen

Tübingen, 72076, Germany

Location

The Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

Weston Park Hospital

Sheffield, S10 2SJ, United Kingdom

Location

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis

Interventions

ontuxizumab; Antibodies, Monoclonal

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Eisai Medical Information
• Organization: Eisai Inc.

esi_medinfo@eisai.com

18882742378

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2011
• First Posted: April 13, 2011
• Study Start: May 16, 2011
• Primary Completion: December 2, 2013
• Study Completion: April 10, 2020
• Last Updated: September 1, 2021
• Results First Posted: September 1, 2021

Record last verified: 2021-04

Locations

US (20); GB (2); AU (4); DE (3)