A Study of IMC-1121B (Ramucirumab) With or Without Dacarbazine in Metastatic Malignant Melanoma

Lilly

Status and phase: Completed; Phase 2

Conditions: Metastatic Malignant Melanoma

Treatments: Drug: Dacarbazine; Biological: IMC-1121B (ramucirumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00533702

CP12-0604 (Other Identifier)

13920

I4T-IE-JVBO (Other Identifier)

Details and patient eligibility

About

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.

Full description

The purpose of this study is to determine the antitumor activity and safety profile of IMC-1121B (ramucirumab) when used alone or in combination with dacarbazine in participants with metastatic melanoma who have not received prior chemotherapy for this disease.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

IMC-1121B (ramucirumab)

Experimental group

Description:

IMC-1121B (ramucirumab)

Treatment:

Biological: IMC-1121B (ramucirumab)

IMC-1121B (ramucirumab) + dacarbazine

Active Comparator group

Description:

IMC-1121B (ramucirumab) + dacarbazine

Treatment:

Drug: Dacarbazine

Biological: IMC-1121B (ramucirumab)