THE IPI - Trial in Advanced Melanoma: Melanoma Patients With Advanced Disease
- Registration Number
- NCT01355120
- Lead Sponsor
- Prof. Dr. med. Dirk Schadendorf
- Brief 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.
- Detailed Description
Treatment:
Treatment with the anti-CTLA-4 mAb Ipilimumab monotherapy of each patient in the scope of this trial is defined as induction plus re-induction of eligible patients until 12 months after first receipt of study medication
Induction phase:
Ipilimumab will be applied to melanoma patients according to the protocol of the completed Medarex study MDX-010-20: Ipilimumab by IV infusion, 3 mg/kg, day 1 (Week 1), 22 (Week 4), 43 (Week 7), 64 (Week 10)
Re-induction:
Patients who progress following stable disease of ≥ 3 months duration starting from diagnosis at week 12 tumor assessment or patients who have progressed following an initial response (partial or complete) assessed at week 12 may be offered additional cycles of therapy with the originally assigned treatment regimen until off-treatment criteria are met, provided they meet re-treatment eligibility requirements. No patient will be re-treated if they experience a Grade 3 or higher gastrointestinal or certain other immune-related adverse events (irAE) (refer to section 5.2 and 5.3). No patient with disease progression following the first cycle of study medication will be permitted to be re-treated with study medication.
Examinations:
The disease will be assessed at baseline, after 12 weeks and for patients with stable disease or better responses, thereafter every 12 weeks in the absence of PD with a maximum of one year. Response evaluation will be done according to immune-related response criteria (Wolchok et al., CCR 2009).
All patients who prematurely discontinued treatment due to a drug-related adverse event prior to Week 12 (in the absence of disease progression) will return for all study visits and procedures including Week 12 and, if appropriate, further re-staging assessments. Any patient with documented progression at any scheduled re-staging visit and who will not receive any re-induction will undergo no further re-staging visits.
Follow-up phase:
Survival will be assessed every 3 months after the final dose of Ipilimumab until the end of the follow-up phase for the individual patient. FU phase for each subject is 1 year following first treatment dose. End of study will be at recruitment finished plus 1 year post start of treatment of last patient thus ensuring that 1 year survival rate can be estimated.
Study duration:
End of study is 1 year post LPFV. Recruiting period for the ocular melanoma:
Period of recruiting 12-18 months Enrolment start date (FPI): QIII 2011 Enrolment finish date (LPI): QI 2013 End of study: QI 2014
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 171
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description a human immunoglobulin Ipilimumab Four infusions (i.v.) of 3mg/kg Ipilimumab in week 1, week 4, week 7 and week 10
- Primary Outcome Measures
Name Time Method Overall survival alive 12 months after date from the first study drug adminstration Overall survival rate at 12 months defined as the rate of patients alive 12 months after the date from the first study treatment for complete study
- Secondary Outcome Measures
Name Time Method safety and efficacy parameters 12 months after date from the first study drug adminstration The primary endpoint is the one-year survival rate. It is defined as the proportion of patients being alive 12 months after their first administration of the study treatment (ipilimumab).
To evaluate possible surrogate markers in peripheral blood and tumour biopsy (translational research program) 12 weeks after date from the first study drug administration Efficacy according to immune-related response criteria (ir-RC) at any time during treatment 12 months after date from the first study drug administration Efficacy according RECIST criteria 12 months after date from the first study drug administration Progression free survival rate at 6 months 6 months after date from the first study drug administration Overall survival at 1 year in the subgroups (cutaneous, uveal, mucosal) 12 months after date from the first study drug administration To explore clinical efficacy of ipilimumab in relation to b-raf mutation status, brain metastases, LDH, HLA-A2 status 12 months after date from the first study drug administration To examine the value of peripheral blood absolute lymphocyte count (ALC) as a predictive biomarker in various patient cohorts with unresectable stage III-IV melanoma treated with ipilimumab monotherapy 12 weeks after date from the first study drug administration
Trial Locations
- Locations (25)
Johannes Wesling Klinikum Minden
🇩🇪Minden, Germany
Ludwig-Maximilians-Universität München
🇩🇪München, Germany
Klinikum Kassel GmbH
🇩🇪Kassel, Hessen, Germany
Klinikum Nürnberg Nord
🇩🇪Nürnberg, Bayern, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Universitätsklinikum Klinik f.Dermatologie, Allegologie u.Venerologie
🇩🇪Lübeck, Schleswig-Holstein, Germany
Charité Universitätsmedizin Berlin, Campus Mitte
🇩🇪Berlin, Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
🇩🇪Ludwigshafen, Germany
Universitätsklinik Köln
🇩🇪Koeln, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Fachklinik Hornheide
🇩🇪Muenster, Germany
Universitätshautklinik Tuebingen
🇩🇪Tuebingen, Germany
Universitätsklinikum Erlangen Hautklinik
🇩🇪Erlangen, Bayern, Germany
Klinikum Dorothea Christiane Erxleben Quedlinburg gGmbH
🇩🇪Quedlinburg, Sachsen-Anhalt, Germany
Krankenhaus Buxtehude
🇩🇪Buxtehude, Germany
Helios Klinikum Erfurt
🇩🇪Erfurt, Germany
Klinikum der Johann Wolfgang Goethe Universität
🇩🇪Frankfurt am Main, Germany
University Hospital Essen
🇩🇪Essen, Germany
Universitätsklinikum Heidelberg Hautklinik
🇩🇪Heidelberg, Germany
Universitätsklinikum des Saarlandes, Homburg
🇩🇪Homburg/Saar, Germany
Klinik Universitätsklinikum Jena Klinik f. Hautkrankheiten
🇩🇪Jena, Germany
Universitätsklinikum Leipzig Dermatologie
🇩🇪Leipzig, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Germany
Universitätsklinikum Mannheim gGmbH, Medizinische Fakultät Mannheim derUniversität Heidelberg
🇩🇪Mannheim, Germany
Universitätsklinikum Münster Klinik u.Poliklinik f.Hautkrankheiten
🇩🇪Münster, Germany
Univ.-Klinikum Regensburg
🇩🇪Regensburg, Germany