Clinical trial · Interventional
A Study of IMC-1121B (Ramucirumab) With or Without Dacarbazine in Metastatic Malignant Melanoma
Phase II Randomized, Open-Label Study of IMC-1121B With or Without Dacarbazine in Patients With Metastatic Malignant Melanoma
NCT00533702CI-TRIAL-00015291completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Malignant Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dacarbazine | Drug | Dacarbazine | ALIAS |
| IMC-1121B (ramucirumab) | Biological | Ramucirumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IMC-1121B (ramucirumab)
- description
- IMC-1121B (ramucirumab)
- interventionNames
- Biological: IMC-1121B (ramucirumab)
- type
- ACTIVE_COMPARATOR
- label
- IMC-1121B (ramucirumab) + dacarbazine
- description
- IMC-1121B (ramucirumab) + dacarbazine
- interventionNames
- Biological: IMC-1121B (ramucirumab)
- Drug: Dacarbazine
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- Baseline up to 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDCarvajal RD, Wong MK, Thompson JA, Gordon MS, Lewis KD, Pavlick AC, Wolchok JD, Rojas PB, Schwartz JD, Bedikian AY. A phase 2 randomised study of ramucirumab (IMC-1121B) with or without dacarbazine in patients with metastatic melanoma. Eur J Cancer. 2014 Aug;50(12):2099-107. doi: 10.1016/j.ejca.2014.03.289. Epub 2014 Jun 12. PMID 24930625