Metastatic Malignant Melanoma MedDRA version: 9.1 Level: LLT Classification code 10027480 Term: Metastatic malignant melanoma
Conditions
Interventions
Product Name: IMC-1121B
Product Code: IMC-1121B
Pharmaceutical Form: Solution for infusion
CAS Number: 947 687-13-0
Current Sponsor code
Sponsors
ImClone Systems Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient has histologically or cytologically confirmed cutaneous malignant melanoma that is American Joint Committee on Cancer (AJCC) stage IV (metastatic). 2. The patient is = 18 years of age. 3. The patient has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1. 4. The patient has completed any prior radiotherapy, biologic/immunotherapy or vaccine therapy (for adjuvant or advanced disease) at least 6 weeks prior to the first dose of study therapy. 5. The patient has a life expectancy > 3 months. 6. The patient has evidence of measurable disease as defined by RECIST. 7. The patient has resolution of all clinically significant toxic effects of prior cancer therapy to grade = 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0 (NCI-CTCAE). 8. The patient has adequate hematological functions (absolute neutrophil count [ANC] = 1500 cells/µL, hemoglobin = 9 g/dL and platelets = 100,000 cells/µL). 9. The patient has adequate hepatic function (bilirubin within normal limits [WNL], aspartate transaminase [AST] and/or alanine transaminase [ALT] = 3.0 times the upper limit of normal [ULN], or = 5.0 times the ULN if the transaminase elevation is due to liver metastases). 10. The patient has serum creatinine = 1.5 x ULN (or a calculated creatinine clearance > 60 mL/min). 11. 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 2 years prior to study), surgically sterile, or is using an effective method of contraception in the opinion of the investigator. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The patient has mucosal or intra-ocular melanoma. 2. The patient has known or suspected brain or leptomeningeal metastases. 3. The patient has had prior cytotoxic chemotherapy for metastatic malignant melanoma. 4. The patient has had more than one line of biologic, immunologic, or vaccine-based therapy for metastatic malignant melanoma (not including adjuvant therapy). 5. The patient has a concurrent active malignancy other than adequately treated non-melanomatous skin cancer or other non-invasive carcinoma or in situ neoplasm. A patient with previous history of malignancy is eligible, provided that he/she has been disease free for > 3 years. 6. The patient has a nonhealing wound or ulcer. 7. The patient has a known alcohol or drug dependency. 8. The patient is pregnant or lactating. 9. 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. 10. 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. 11. The patient has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness. 12. The patient has uncontrolled or poorly controlled hypertension despite standard medical management (>140 mmHg systolic or > 90 mmHg diastolic).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the progression-free survival (PFS) of patients with metastatic malignant melanoma who have not received prior chemotherapy for metastatic disease when treated with IMC-1121B alone or in combination with dacarbazine.; Secondary Objective: The secondary objectives will be to: • Assess the safety and tolerability of IMC-1121B alone and in combination with dacarbazine • Measure overall response rate (ORR) • Determine median duration of response • Measure stable disease rate at 6 weeks and 12 weeks • Determine 12-week response rate • Assess the pharmacokinetics of IMC-1121B alone and in combination with dacarbazine ; Primary end point(s): The primary efficacy endpoint for this study is PFS. PFS is defined as the time from the day of randomization to the first evidence of progression as defined by RECIST or death from any cause. Patients who die without a reported prior progression will be considered to have progressed on the day of their death. Patients who do not progress and are subsequently lost to follow-up will have their data censored at the day of their last tumor assessment. The Kaplan-Meier method will be used to analyze PFS and to estimate the median survival time. The Kaplan-Meier survival curves will be presented as stratified. Log-rank test will be used to compare the survival curves for the stratification factors LDH status and extent-of-metastasis. The 95% confidence interval for the median survival time will be provided. A univariate Cox proportional hazards model analysis will be performed using treatment as a simple covariate and LDH status and extent of metastasis as strata. | — |
Countries
United Kingdom
Outcome results
None listed