Phase 2
Completed N=40
A Study of Bevacizumab (Avastin) in Combination With Dacarbazine in Participants With Unresectable/Metastatic Melanoma
Source: ClinicalTrials.gov NCT01164007 ↗Enrolled (actual)
40
Serious AEs
13.5%
Results posted
Apr 2017
Primary outcomePrimary: Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) — 18.92 percentage of participants — p=0.071
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) |
18.92 | 0.071 |
| SECONDARY Percentage of Participants With Death or Disease Progression Following a Previous Assessment of CR or PR According to RECIST |
57.14 | — |
| SECONDARY Duration of Response (DOR) With CR or PR According to RECIST |
16.89 | — |
| SECONDARY Percentage of Participants With Death or Disease Progression Following a Previous Assessment of CR, PR, or Stable Disease (SD) According to RECIST |
72.22 | — |
| SECONDARY DOR With CR, PR, or SD According to RECIST |
12.52 | — |
| SECONDARY Percentage of Participants With Death or Disease Progression According to RECIST |
81.08 | — |
| SECONDARY Time to Progression (TTP) According to RECIST |
5.48 | — |
| SECONDARY Percentage of Participants Who Discontinued Treatment |
91.89 | — |
| SECONDARY Time to Treatment Failure (TTF) |
3.05 | — |
| SECONDARY Percentage of Participants Who Died |
81.08 | — |
| SECONDARY Overall Survival (OS) |
11.41 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01164007). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.