Clinical trial · Interventional
A Study of Avastin (Bevacizumab) in Combination With Fotemustine in Patients With Metastatic Melanoma
An Open-label Study to Assess the Anti-tumor Activity of Avastin in Combination With Fotemustine as First-line Therapy in 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 study will investigate the efficacy and safety of bevacizumab + fotemustine in patients with stage IV melanoma, previously untreated with chemo- or immunotherapy for metastatic disease. Patients will receive Avastin (15mg/kg intravenously\[IV\]) on Day 1 of every 3 week cycle, in combination with fotemustine (100mg/m² IV) on Days 1, 8 and 15, followed by 4 weeks rest, followed by 100mg/m² IV every 3 weeks for 4-6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.
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 |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab [Avastin] | Drug | Bevacizumab | ALIAS |
| fotemustine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: bevacizumab [Avastin]
- Drug: fotemustine
Primary outcomes (2)
- measure
- Percentage of Participants With Complete Response (CR) or Partial Response (PR)
- timeFrame
- Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months
- description
- The percentage of participants with an objective response, defined as achieving CR or PR, as evaluated by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target), PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
- measure
- Percentage of Participants With Clinical Benefit of CR, PR, or Stable Disease (SD)
- timeFrame
- Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * cutaneous malignant melanoma; * advanced, inoperable stage IV melanoma; * measurable and/or evaluable sites of metastases. Exclusion Criteria: * prior chemotherapy and/or IFN/IL2 based immunotherapy for metastatic disease; * prior malignancies within past 5 years, with the exception of cured non-melanoma skin cancer, or in situ cancer of cervix; * clinically significant cardiovascular disease; * ongoing treatment with aspirin (\>325mg/day) or other medications known to predispose to gastrointestinal ulceration.
References
Publications (1)
- DERIVEDDel Vecchio M, Mortarini R, Canova S, Di Guardo L, Pimpinelli N, Sertoli MR, Bedognetti D, Queirolo P, Morosini P, Perrone T, Bajetta E, Anichini A. Bevacizumab plus fotemustine as first-line treatment in metastatic melanoma patients: clinical activity and modulation of angiogenesis and lymphangiogenesis factors. Clin Cancer Res. 2010 Dec 1;16(23):5862-72. doi: 10.1158/1078-0432.CCR-10-2363. Epub 2010 Oct 28. PMID 21030496