Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma and Predictive Value of Angiogenic Markers
In Norway, cutaneous malignant melanoma is the second most frequent and the most frequent
cancer type in middle-aged (30-54 years) females and males, respectively, and the incidence
has six-doubled during the last 30 years. Median survival for patients with metastatic
melanoma is 6 months.
Many agents have been investigated for anti-tumor effect in melanoma, but there is no
accepted standard therapy. Biochemotherapy, combining cytotoxic drugs with Interleukin-2 or
Interferon alpha, has not been shown to be superior to single agent Dacarbazine (DTIC),
which is regarded to be the most active agent. Other biological approaches like vaccination
are currently under investigation, but still no efficient treatment for metastatic melanoma
is available. DTIC induces objective remission in 20% of the patients, but without
significant impact on survival.
The need of a new and effective treatment for the group of melanoma patients is urgently
needed. This will be the first study to assess response rates of bevacizumab monotherapy in
first line treatment of metastatic melanoma. In addition there will be a major focus on the
identification of predictive biomarkers of bevacizumab efficacy.
LEVEL A (second line): after confirmed progression on standard first line treatment with
LEVEL B (first line): when objective clinical response is observed in LEVEL A, patients
will be included for first line treatment with bevacizumab
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical Response rates
Oddbjorn Straume, MD, PhD
Department of Oncology, Haukeland University Hospital
Norway: Norwegian Medicines Agency