drugset / Trial / NCT01689870
Study of the Combination of Anti-OX40 and Ipilimumab in Patients With Metastatic Melanoma
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is an open label, two-phase study combining a dose escalation Phase 1 with a proof-of-concept Phase 2 in patients with unresectable or metastatic melanoma, for whom treatment with ipilimumab is indicated. The purpose of the Phase 1 is to determine the Anti-OX40 Maximum Tolerated Dose (MTD) and the secondary objectives are anti-OX40 pharmacokinetics, biological activity and the tumor response assessed by the Immune-related Response Criteria. The purpose of Phase 2 is to determine tumor response (by irRC) and the secondary objectives are anti-OX40 pharmacokinetics, biological activity and Safety/Tolerability.
Timeline
- Start
- 2014-03
- Primary completion
- 2014-06
- Completion
- 2014-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Ipilimumab | Monoclonal antibody | 3 mg/kg | Intravenous |