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Phase II Randomized, Open-Label Study of IMC-1121B With or Without Dacarbazine in Patients With Metastatic Malignant Melanoma

Phase 2
18 Years
Not Enrolling
Metastatic Malignant Melanoma

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Trial Information

Phase II Randomized, Open-Label Study of IMC-1121B With or Without Dacarbazine in Patients With Metastatic Malignant Melanoma

The purpose of this study is to determine the antitumor activity and safety profile of
ramucirumab when used alone or in combination with dacarbazine in patients with metastatic
melanoma who have not received prior chemotherapy for this disease.

Inclusion Criteria:

- The patient has histologically or cytologically confirmed melanoma that is stage IV

- The patient has an ECOG PS of 0-1

- The patient 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 patient has adequate hematological functions (absolute neutrophil count [ANC]≥
1500 cells/μL, hemoglobin ≥ 9 g/dL and platelets ≥ 100,000 cells/μL).

- The patient 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 patient has serum creatinine ≤ 1.5 x ULN (or a calculated creatinine clearance >
60 mL/min)

- The patient'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 mg of protein in 24 hours to allow participation in the study)

- The patient 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 patient has mucosal or intra-ocular melanoma

- The patient has known or suspected brain or leptomeningeal metastases

- The patient has had prior cytotoxic chemotherapy for metastatic malignant melanoma

- The patient has had more than one line of biologic, immunologic or vaccine-based
therapy for metastatic malignant melanoma (including therapy for adjuvant or advanced

- The patient has a nonhealing wound or ulcer

- The patient has a known alcohol or drug dependency

- The patient is pregnant or breastfeeding

- The patient 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 patient 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free survival (PFS)

Outcome Description:

PFS is defined as the time from randomization to the first evidence of progression as defined by RECIST or death from any cause.

Outcome Time Frame:

Approximately 18 weeks

Safety Issue:


Principal Investigator

E-mail: ClinicalTrials@

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC


United States: Food and Drug Administration

Study ID:




Start Date:

November 2007

Completion Date:

May 2011

Related Keywords:

  • Metastatic Malignant Melanoma
  • Phase II
  • Melanoma
  • IMC-1121B
  • ImClone
  • Melanoma



ImClone Investigational SiteDenver, Colorado  80262
ImClone Investigational SiteNew York, New York  10021
ImClone Investigational SiteBakersfield, California  93309
ImClone Investigational SiteJacksonville, Florida  32207
ImClone Investigational SiteGreat Falls, Montana  59405
ImClone Investigational SiteDallas, Texas  75230
ImClone Investigational SitePhiladelphia, Pennsylvania  19107
ImClone Investigational SiteTucson, Arizona  85712
ImClone Investigational SiteJackson, Mississippi  39202
ImClone Investigational SiteSeattle, Washington  98104
ImClone Investigational SiteBirmingham, Alabama  35233