Refractory Melanoma
Conditions
Keywords
refractory melanoma, malignant melanoma
Brief summary
CP-675,206 is a fully human monoclonal antibody (mAb). It binds to the CTLA4 molecule, which is expressed on the surface of activated T lymphocytes. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. CP-675,206 is not expected to have a direct effect on tumor cells. CP-675,206 been shown to induce durable tumor responses in patients with metastatic melanoma in Phase 1 and Phase 2 clinical studies.
Interventions
DRUGCP-675,206
15 mg/kg Q12W dosing regimen
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Surgically incurable Stage III or IV melanoma * One prior systemic treatment for metastatic melanoma * Measurable disease * Eastern Cooperative Oncology Group (ECOG) PS = 0 or 1
Exclusion criteria
* Melanoma of ocular origin * Received prior vaccine * Received prior CTLA4-inhibiting agent * History of, or significant risk for, chronic inflammatory or autoimmune disease * Potential requirement for systemic corticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the anti-tumor efficacy, as determined by objective response rate, of intravenous CP-675,206 administered at a dose of 15 mg/kg every 90 days to patients with relapsed or refractory advanced melanoma | Tumor response is assessed every 2-3 months until disease progression |
Secondary
| Measure | Time frame |
|---|---|
| Safety | At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug |
| Pharmaco Kinetic | At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug |
| Survival | At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug |
| Health-related QoL | At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug |
Countries
Argentina, Australia, Canada, France, Germany, Italy, Spain, United Kingdom, United States
Outcome results
None listed