A Study of Bevacizumab (Avastin) in Combination With Dacarbazine in Participants With Unresectable/Metastatic Melanoma

Roche

Status and phase: Completed; Phase 2

Conditions: Malignant Melanoma

Treatments: Drug: Dacarbazine; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01164007

2005-003416-30 (EudraCT Number)

ML18727

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Dacarbazine + Bevacizumab

Experimental group

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.

Treatment:

Drug: Bevacizumab

Drug: Dacarbazine