Clinical trial · Interventional
A Study of Bevacizumab With Carboplatin and Paclitaxel Chemotherapy for the First-Line Treatment of Patients With Metastatic Melanoma
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Carboplatin and Paclitaxel Chemotherapy for the First-Line Treatment of Patients With Metastatic Melanoma
- 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)
This Phase II, multicenter, randomized, double-blind, placebo-controlled trial was designed to estimate the efficacy and characterize the safety of bevacizumab when combined with carboplatin + paclitaxel chemotherapy compared with carboplatin + paclitaxel chemotherapy alone in patients with previously untreated metastatic melanoma.
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 |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| carboplatin | Drug | Carboplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Carboplatin+Paclitaxel+Placebo
- interventionNames
- Drug: carboplatin
- Drug: paclitaxel
- Drug: placebo
- type
- EXPERIMENTAL
- label
- Carboplatin+Paclitaxel+Bevacizumab
- interventionNames
- Drug: bevacizumab
- Drug: carboplatin
- Drug: paclitaxel
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- From randomization up to102 weeks. As of the clinical cut-off date (April 2009), the maximum time on treatment was 88 weeks, median time was 12.4 weeks for the Placebo arm and 16.1 weeks for the bevacizumab arm.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed Informed Consent Form * Age ≥ 18 years * Metastatic melanoma (Stage IV) * Histologically confirmed malignant melanoma with measurable or non-measurable disease * Ability and willingness to comply with study and follow-up procedures Exclusion Criteria: * Prior treatment for Stage IV disease with chemotherapy or biologic therapy such as interferon and interleukin-2 * Complete surgical resection or irradiation of all identifiable sites of disease at randomization * Radiation therapy within 14 days prior to Day 1 * Prior therapy with bevacizumab, sorafenib, sunitinib, or other vascular endothelial growth factor (VEGF) pathway-targeted therapy * Melanoma of ocular origin * Known central nervous system (CNS) disease/brain metastases (history of brain disease or active disease) * Life expectancy of \< 12 weeks * Current, recent, or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study * Inadequate organ function * History of other malignancies within 5 years of Day 1, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix * Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications * Inadequately controlled hypertension * History of hypertensive crisis or hypertensive encephalopathy * New York Heart Association (NYHA) Class II or greater CHF * History of myocardial infarction or unstable angina within 6 months prior to Day 1 * History of stroke or transient ischemic attack within 6 months prior to Day 1 * Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis within 6 months prior to Day 1 * History of hemoptysis within 1 month prior to Day 1 * Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study * Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1 * History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1 * Serious, non-healing wound, active ulcer, or untreated bone fracture * Known hypersensitivity to any component of bevacizumab * Pregnancy (positive pregnancy test) or lactation * Current, ongoing treatment with full-dose warfarin
References
Publications (0)
Data not yet available