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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Melanoma

Treatments: Drug: CP-675,206; Drug: dacarbazine; Drug: temozolomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00257205

A3671009

Details and patient eligibility

About

This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)

Enrollment: 655 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

655 participants in 2 patient groups

B

Active Comparator group

Description:

Choice of one or the other Dacarbazine or Temozolomide(CP-675,206) (choice)

Treatment:

Drug: dacarbazine

Drug: temozolomide

A

Experimental group

Treatment:

Drug: CP-675,206