---
title: A Study of IMC-1121B (Ramucirumab) With or Without Dacarbazine in Metastatic Malignant Melanoma
nct_id: NCT00533702
overall_status: COMPLETED
phase: PHASE2
sponsor: Eli Lilly and Company
study_type: INTERVENTIONAL
primary_condition: Metastatic Malignant Melanoma
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00533702.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00533702"
ct_last_update_post_date: 2014-08-01
last_seen_at: "2026-05-12T07:11:12.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of IMC-1121B (Ramucirumab) With or Without Dacarbazine in Metastatic Malignant Melanoma

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

**NCT ID:** [NCT00533702](https://clinicaltrials.gov/study/NCT00533702)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 106
- **Lead Sponsor:** Eli Lilly and Company
- **Conditions:** Metastatic Malignant Melanoma
- **Start Date:** 2007-11
- **Completion Date:** 2011-05
- **CT.gov Last Update:** 2014-08-01

## Brief 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.

## Detailed 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **IMC-1121B (ramucirumab)** (EXPERIMENTAL) — IMC-1121B (ramucirumab)
- **IMC-1121B (ramucirumab) + dacarbazine** (ACTIVE_COMPARATOR) — IMC-1121B (ramucirumab) + dacarbazine

## Interventions

- **IMC-1121B (ramucirumab)** (BIOLOGICAL) — 10 milligrams/kilogram (mg/kg) intravenously every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
- **Dacarbazine** (DRUG) — 1000 milligrams/square meter (mg/m2) intravenously every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.

## Primary Outcomes

- **Progression Free Survival (PFS)** _(time frame: Baseline up to 36 months)_ — PFS was defined as the time from the first day of therapy to the first evidence of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions, taking as reference the smallest sum LD recorded since the treatment started in comparison with the measurement of the nadir or the appearance of 1 or more new lesions. In addition, unequivocal progression of existing non-target lesions was considered PD. New or existing pleural effusion/ascites required cytological confirmation for PD according to the protocol. Participants who did not progress and who were alive or did not have documented progression or missed ≥2 visits, or had no post baseline assessment were censored at the day of their last tumor assessment.

## Secondary Outcomes

- **Number of Participants With Adverse Events (AE)** _(time frame: Baseline up to 40 months)_
- **Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]** _(time frame: Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months)_
- **Duration of Response** _(time frame: Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months)_
- **Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 6 Weeks** _(time frame: 6 weeks (2 cycles of treatment))_
- **Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 12 Weeks** _(time frame: 12 weeks (4 cycles of treatment))_
- **Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate) at 12 Weeks** _(time frame: 12 weeks (4 cycles of treatment))_
- **Maximum Concentration (Cmax) for Cycle 1 Day 1** _(time frame: Cycle 1 Day 1 (21-day cycle) 1-hour post infusion)_
- **Maximum Concentration (Cmax) for Cycle 1 Day 7** _(time frame: Cycle 1 Day 7 (21-day cycle))_
- **Maximum Concentration (Cmax) for Cycle 1 Day 14** _(time frame: Cycle 1 Day 14 (21-day cycle))_

## Locations (17)

- ImClone Investigational Site, Decatur, Alabama, United States
- ImClone Investigational Site, Scottsdale, Arizona, United States
- ImClone Investigational Site, Scottsdale, Arizona, United States
- ImClone Investigational Site, Fresno, California, United States
- ImClone Investigational Site, San Francisco, California, United States
- ImClone Investigational Site, Aurora, Colorado, United States
- ImClone Investigational Site, Jacksonville, Florida, United States
- ImClone Investigational Site, Orlando, Florida, United States
- ImClone Investigational Site, Oxford, Mississippi, United States
- ImClone Investigational Site, Missoula, Montana, United States
- ImClone Investigational Site, Buffalo, New York, United States
- ImClone Investigational Site, New York, New York, United States
- ImClone Investigational Site, New York, New York, United States
- ImClone Investigational Site, Willow Grove, Pennsylvania, United States
- ImClone Investigational Site, Dallas, Texas, United States
- ImClone Investigational Site, Houston, Texas, United States
- ImClone Investigational Site, Seattle, Washington, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.imclone investigational site|decatur|alabama|united states` — added _(2026-05-12)_
- `locations.imclone investigational site|scottsdale|arizona|united states` — added _(2026-05-12)_
- `locations.imclone investigational site|fresno|california|united states` — added _(2026-05-12)_
- `locations.imclone investigational site|san francisco|california|united states` — added _(2026-05-12)_
- `locations.imclone investigational site|aurora|colorado|united states` — added _(2026-05-12)_
- `locations.imclone investigational site|jacksonville|florida|united states` — added _(2026-05-12)_
- `locations.imclone investigational site|orlando|florida|united states` — added _(2026-05-12)_
- `locations.imclone investigational site|oxford|mississippi|united states` — added _(2026-05-12)_
- `locations.imclone investigational site|missoula|montana|united states` — added _(2026-05-12)_
- `locations.imclone investigational site|buffalo|new york|united states` — added _(2026-05-12)_
- `locations.imclone investigational site|new york|new york|united states` — added _(2026-05-12)_
- `locations.imclone investigational site|willow grove|pennsylvania|united states` — added _(2026-05-12)_
- `locations.imclone investigational site|dallas|texas|united states` — added _(2026-05-12)_
- `locations.imclone investigational site|houston|texas|united states` — added _(2026-05-12)_
- `locations.imclone investigational site|seattle|washington|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00533702.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00533702*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*