Clinical trial · Interventional
A Study of Bevacizumab (Avastin) in Combination With Dacarbazine in Participants With Unresectable/Metastatic Melanoma
Phase II Study of Dacarbazine With the Anti-Vascular Endothelial Growth Factor Antibody (Bevacizumab) in Patients With Unresectable/Metastatic Melanoma
NCT01164007CI-TRIAL-00027128completedPhase 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)
This study will assess the preliminary anti-tumor activity and safety profile of a combination of bevacizumab and dacarbazine in participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease.
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 | Drug | Bevacizumab | ALIAS |
| Dacarbazine | Drug | Dacarbazine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dacarbazine + Bevacizumab
- description
- Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease will receive dacarbazine and bevacizumab until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
- interventionNames
- Drug: Bevacizumab
- Drug: Dacarbazine
Primary outcomes (1)
- measure
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST)
- timeFrame
- Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)
- description
- Tumor assessments were performed using RECIST. CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to sum of LD at Baseline. Both were to be confirmed at a follow-up visit at least 4 weeks from the initial assessment of CR or PR. The percentage of participants with a best overall response of CR or PR during the study was reported.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed cutaneous malignant melanoma * Clinical evidence of metastatic disease and/or unresectable regional lymphatic disease and/or extensive in transit recurrent disease * Measurable and/or evaluable lesions according to RECIST Exclusion Criteria: * Prior interferon alfa and/or cytokine therapy for metastatic disease * Prior chemotherapy for metastatic disease * Brain metastases * Chronic daily treatment with high-dose aspirin (more than 325 milligrams per day) * Other co-existing malignancies or malignancies diagnosed within the past 5 years with the exception of basal cell cancer or cervical cancer in situ
References
Publications (0)
Data not yet available
No reference posted for this study.