Study of the Combination of Anti-OX40 and Ipilimumab in Patients With Metastatic Melanoma
Status:
Withdrawn
Trial end date:
2014-08-01
Target enrollment:
Participant gender:
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.