Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00257205 | CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy | PHASE3 | COMPLETED | 655 | — | — | Mar 1, 2006 | Aug 1, 2010 | Jul 2, 2012 | 143 | United States, Argentina +19 |
| NCT00431275 | Study to Compare Two Formulations of CP-675,206 Monoclonal Antibody | PHASE1 | COMPLETED | 85 | — | — | Jun 1, 2006 | Feb 1, 2008 | Jun 6, 2012 | 8 | United States |
| Arm | Type | Description |
|---|---|---|
| B | ACTIVE_COMPARATOR | Choice of one or the other Dacarbazine or Temozolomide(CP-675,206) (choice) |
| A | EXPERIMENTAL | - |
| Commercial Formulation | EXPERIMENTAL | Commercial Formulation |
| Current Formulation | EXPERIMENTAL | Current Formulation |
| Name | Type | Description |
|---|---|---|
| dacarbazine | DRUG | decarbazine 1000 mg/m2 IV Q 21 days x 12 |
| CP-675,206 | DRUG | CP-675,206 15 mg/kg IV Q 90 days x 4 |
| temozolomide | DRUG | temozolomide 200 mg/m2 orally on Days 1-5 every 28 days x 12 |
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...