CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy

Trial Information

A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma

Inclusion Criteria:

- Surgically incurable melanoma, either Stage IV or IIIC with N3 status for regional
lymph nodes and in-transit or satellite lesions.

- Serum lactic acid dehydrogenase (LDH) <= 2 x ULN

- ECOG performance status of 0 or 1

Exclusion Criteria:

- Received any systemic therapy for metastatic melanoma except post-surgical adjuvant
treatment with cytokines (eg, alpha-interferon or GM-CSF) or with vaccines after
complete resection of melanoma.

- History of brain metastases

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

August 2010

Safety Issue:

Authority:

United States: Food and Drug Administration

Study ID:

A3671009

NCT ID:

NCT00257205

Start Date:

March 2006

Completion Date: