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THE IPI - Trial in Advanced Melanoma: Melanoma Patients With Advanced Disease

NCT01355120 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2025-04-09

No results posted yet for this study

Summary

This is an open-label, multi-center, single-arm clinical phase II study to further characterize the efficacy and safety of ipilimumab in patients with or without systemic pretreatment metastatic ocular melanoma.

The DeCOG-MM-PAL11-Trial will be continued only for patients with ocular melanoma because sufficient numbers of cutaneous and mucosal melanoma patients have already been recruited. In order to allow the separate subgroup analysis as planned in the protocol for ocular melanoma it is mandatory to focus the recruitment to this patient population. Only this will guarantee a valid evaluation of all cohorts. Ocular melanoma is defined as melanomas originated from uvea, the choroid, the ciliary body and conjunctiva. (see McCartney ACE "Pathology of ocular melanomas" British Medical Bulltta, 1995, Vol 51, No 3 pp 678-693) The same criteria and treatment procedure as those used before will be applied for the patients with advanced ocular melanoma. Since no treatment standard in those patients does exist, also patients without prior systemic treatment can be included in this study. Therefore, the 5th inclusion criterion has been adapted in order to enrol the eligible patients.

Conditions

  • Ocular Melanoma

Interventions

DRUG

Ipilimumab

Ipilimumab monotherapy 3mg/kg by four infusion every 3 weeks

Sponsors & Collaborators

  • Prof. Dr. med. Dirk Schadendorf

    lead OTHER

Principal Investigators

  • Dirk Schadendorf, Professor · University Hospital, Essen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-09-30
Completion
2013-09-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01355120 on ClinicalTrials.gov