A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 655
- Locations
- 1
- Primary Endpoint
- overall survival
Study Overview
Brief Summary
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
B
Choice of one or the other Dacarbazine or Temozolomide(CP-675,206) (choice)
Intervention: dacarbazine (Drug)
B
Choice of one or the other Dacarbazine or Temozolomide(CP-675,206) (choice)
Intervention: temozolomide (Drug)
A
Intervention: CP-675,206 (Drug)
Outcomes
Primary Outcomes
overall survival
Time Frame: August 2010
Secondary Outcomes
- adverse events(1 year)
- PFS at 6 months(6 months)
- objective tumor response(1 year)
- Durable response(6 months)
- pharmacokinetics endpoints(15 months)
- pharmacogenomic endpoints(1 year)
- HQol(1 year)
- healthcare resource utilization and loss of productivity(1 year)
- human antihuman antibody response for patients in Arm A(15 months)