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

Sponsor
University Hospital Tuebingen
Study ID
NCT01480323
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Interleukin-2 — DRUG
    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
  • Ipilimumab — DRUG
    IV infusion, 3 mg/kg, day 2, 23, 44, 65

Study Details

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.

Key Dates

Start date
Feb 29, 2012
Status verified
Jul 2015
Primary completion
Sep 30, 2014
Completion
Jun 30, 2015

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab
    Ipilimumab i.v. + Interleukin-2 intratumoral

Primary Outcome Measure

Control rate [ Time Frame: at week 12 ]

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