Clinical trial · Interventional
Study of CP-675,206 in Refractory Melanoma
A Phase 2, Open Label, Single Arm Study To Evaluate The Efficacy, Safety, Tolerability And Pharmacokinetics Of CP-675,206 In Patients With Advanced Refractory And/Or Relapsed Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CP-675,206 | Drug | Tremelimumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 15 mg/kg CP-675,206
- interventionNames
- Drug: CP-675,206
Primary outcomes (1)
- measure
- 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
- timeFrame
- Tumor response is assessed every 2-3 months until disease progression
Secondary outcomes (4)
- measure
- Safety
- timeFrame
- At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug
- measure
- Pharmaco Kinetic
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available