NCT01480323

A Phase II Study to Evaluate Safety and Efficacy of Combined Treatment With Ipilimumab and Intratumoral Interleukin-2

A Phase II Study to Evaluate Safety and Efficacy of Combined Treatment With Ipilimumab and Intratumoral Interleukin-2 in Pretreated Patients With Stage IV Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The current clinical trial shall clarify a synergistic effect with regards to efficiency by the combination of intratumoral injection of interleukin-2 (IL-2) and the intra-venous application of ipilimumab.

Detailed description

Intratumoral injection of interleukin-2 (IL-2) into melanoma metastases is a highly efficient local treatment. Furthermore, a systemic effect is assumed based on the observation of a favorable long term outcome. However, objective responses in untreated lesions have not been observed yet. Ipilimumab seems to be efficient in a subset of treated patients by inhibition of down-regulation of tumor-specific cellular immune-responses. In the context of the proposed trial, we assume (i) that ipilimumab could potentiate systemic melanoma-specific immune responses, which are primarily induced by intratumoral IL-2 and (ii) that these immune responses become more effective with regards to not IL-2 injected distant lesions. Therefore we assume a synergistic effect with regards to efficiency by the combination.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Interleukin-2	intratumoral injections of 9 MIU/day on days 1, 4, 8, 11, 15, 18, 22 and 25. The administered dose will be distributed between all injectable soft-tissue metastases
DRUG	Ipilimumab	IV infusion, 3 mg/kg, day 2, 23, 44, 65

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-09-01
• Completion: 2015-06-01
• First posted: 2011-11-28
• Last updated: 2015-07-21

Locations

1 site across 1 country: Germany