Clinical trial · Interventional
Bevacizumab Combined With Carboplatin Plus Paclitaxel Chemotherapy to Treat Metastatic Mucosal Melanoma
A Randomized Phase II Study Evaluating the Activity of Bevacizumab in Combination With Carboplatin Plus Paclitaxel in Patients With Previously Untreated Advanced Mucosal Melanoma
NCT02023710CI-TRIAL-00027456unknownPhase 2ClinicalTrials.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)
Mucosal melanoma is rare and associated with extremely poor prognosis.No effective treatment for advanced mucosal melanoma patients.Investigators conducted a randomized phase II study in patients with previously untreated metastatic mucosal melanoma to characterize the efficacy and safety of bevacizumab when combined with carboplatin plus paclitaxel.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BEV plus Chemotherapy
- description
- Paclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; Bevacizumab 5mg/kg, d1、15; 28 days a cycle
- interventionNames
- Drug: Paclitaxel
- Drug: Carboplatin
- Drug: Bevacizumab
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy alone
- description
- Paclitaxel 175mg/m2, d1; Carboplatin AUC=5, d1; 28 days a cycle
- interventionNames
- Drug: Paclitaxel
- Drug: Carboplatin
Primary outcomes (1)
- measure
- progress-free survival(PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed mucosal melanoma with metastases and has no received any systemic treatment. 2. ECOG performance status 0, 1 3. Estimated life expectancy of 12 weeks or greater 4. Age 18 years or older, male or female 5. At least one measurable site (diameter≥1cm) of disease (RECIST 1.1). 6. Adequate organ function 7. Without symptoms of brain metastases and stable in neuro-functions. 8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures Exclusion Criteria: 1. Mutations in C-KIT or BRAF-V600E, asked for other target treatments 2. Pregnant or lactation women 3. Acute infections without control. 4. Heart disease history, cardiac function class≥NYHA II. 5. HIV positive or chronic HBV/HCV in active stage. 6. Brain metastases or primary tumor with positive symptoms 7. Need anti-epileptic treatments 8. Organ transplantation history 9. Hemorrhagic tendency or related history 10. Renal dialysis patients 11. Diagnosis of any second malignancy within the last 3 years, except for adequately treated. 12. Current treatment on another clinical trial 13. The other improper situations which investigator judged.
References
Publications (4)
- BACKGROUNDKim KB, Sosman JA, Fruehauf JP, Linette GP, Markovic SN, McDermott DF, Weber JS, Nguyen H, Cheverton P, Chen D, Peterson AC, Carson WE 3rd, O'Day SJ. BEAM: a randomized phase II study evaluating the activity of bevacizumab in combination with carboplatin plus paclitaxel in patients with previously untreated advanced melanoma. J Clin Oncol. 2012 Jan 1;30(1):34-41. doi: 10.1200/JCO.2011.34.6270. Epub 2011 Nov 28. PMID 22124101
- BACKGROUNDChi Z, Li S, Sheng X, Si L, Cui C, Han M, Guo J. Clinical presentation, histology, and prognoses of malignant melanoma in ethnic Chinese: a study of 522 consecutive cases. BMC Cancer. 2011 Feb 25;11:85. doi: 10.1186/1471-2407-11-85. PMID 21349197
- BACKGROUNDLian B, Si L, Cui C, Chi Z, Sheng X, Mao L, Li S, Kong Y, Tang B, Guo J. Phase II randomized trial comparing high-dose IFN-alpha2b with temozolomide plus cisplatin as systemic adjuvant therapy for resected mucosal melanoma. Clin Cancer Res. 2013 Aug 15;19(16):4488-98. doi: 10.1158/1078-0432.CCR-13-0739. Epub 2013 Jul 5. PMID 23833309
- DERIVEDYan X, Sheng X, Chi Z, Si L, Cui C, Kong Y, Tang B, Mao L, Wang X, Lian B, Li S, Bai X, Zhou L, Dai J, Yao H, Guo J. Randomized Phase II Study of Bevacizumab in Combination With Carboplatin Plus Paclitaxel in Patients With Previously Untreated Advanced Mucosal Melanoma. J Clin Oncol. 2021 Mar 10;39(8):881-889. doi: 10.1200/JCO.20.00902. Epub 2021 Jan 14. PMID 33444116