NCT01689870

Study of the Combination of Anti-OX40 and Ipilimumab in Patients With Metastatic Melanoma

Phase 1/2 Study of the Combination of a Mouse Monoclonal Antibody to OX40 and Ipilimumab in Patients With Metastatic Melanoma

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ludwig Institute for Cancer Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	Anti-OX40	Anti-OX40 will be administered i.v. over 60 minutes only in the first week on Days 1, 3 and 5
DRUG	Ipilimumab	Ipilimumab will be administered at 3 mg/kg i.v. over 90 minutes every 3 weeks for a total of 4 doses, starting on Day 1

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-06-01
• Completion: 2014-08-01
• First posted: 2012-09-21
• Last updated: 2014-04-01