A Study of IMC-1121B (Ramucirumab) With or Without Dacarbazine in Metastatic Malignant Melanoma
Condition: Metastatic Malignant Melanoma
MeSH terms: Melanoma
Intervention: IMC-1121B (ramucirumab); Dacarbazine
Intervention description: 10 milligrams/kilogram (mg/kg) intravenously every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.; 1000 milligrams/square meter (mg/m2) intravenously every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Intervention MeSH terms: Dacarbazine; Ramucirumab; Antibodies, Monoclonal; Imidazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase II; Melanoma; IMC-1121B; ImClone

Summary:

      The primary objective of this study is to determine the progression-free survival (PFS) of
      participants with previously untreated metastatic malignant melanoma when treated with
      IMC-1121B (ramucirumab) alone or in combination with dacarbazine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant has histologically or cytologically confirmed melanoma that is stage
             IV (metastatic)

          -  The participant has an Eastern Cooperative Oncology Performance Status (ECOG PS) of
             0-1

          -  The participant has completed any prior radiotherapy, biologic/immunotherapy or
             vaccine therapy (for adjuvant or advanced disease) at least six weeks prior to the
             first dose of study therapy

          -  The participant has adequate hematological functions [absolute neutrophil count (ANC)
             ≥ 1500 cells/microliter (μL), hemoglobin ≥ 9 grams/deciliter (g/dL) and platelets ≥
             100,000 cells/μL].

          -  The participant has adequate hepatic function [bilirubin within normal limits (WNL),
             aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤ 2.5 times the upper
             limit of normal (ULN), or ≤ 5.0 times the ULN if the transaminase elevation is due to
             liver metastases]

          -  The participant has serum creatinine ≤ 1.5 x ULN [or a calculated creatinine clearance
             > 60 milliliters/minute (mL/min)]

          -  The participant's urinary protein ≤ 1+ on dipstick or routine urinalysis [(UA); if
             urine dipstick or routine analysis is ≥ 2+, a 24-hour urine for protein must
             demonstrate < 1000 milligrams (mg) of protein in 24 hours to allow participation in
             the study]

          -  The participant must have adequate coagulation function as defined by International
             Normalized Ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 1.5 X ULN

        Exclusion Criteria

          -  The participant has mucosal or intra-ocular melanoma

          -  The participant has known or suspected brain or leptomeningeal metastases

          -  The participant has had prior cytotoxic chemotherapy for metastatic malignant melanoma

          -  The participant has had more than one line of biologic, immunologic or vaccine-based
             therapy for metastatic malignant melanoma (including therapy for adjuvant or advanced
             disease)

          -  The participant has a nonhealing wound or ulcer

          -  The participant has a known alcohol or drug dependency

          -  The participant is pregnant or breastfeeding

          -  The participant has a coexisting medical or psychiatric problem of sufficient severity
             to limit compliance with the study and/or increase the risks associated with study
             participation or study drug administration or interfere with the interpretation of
             study results

          -  The participant has an ongoing or active infection, symptomatic congestive heart
             failure, unstable angina pectoris, symptomatic or poorly controlled cardiac
             arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled
             medical disorders in the opinion of the investigator