Clinical Trial: Adjuvant Therapy of Completely Resected Merkel Cell Carcinoma With 3 mg/kg BW Ipilimumab (Yervoy®) Versus Observation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prospective Randomized Trial of an Adjuvant Therapy of Completely Resected Merkel Cell Carcinoma (MCC) With 3 mg/kg BW Ipilimumab (Yervoy®) Every 3 Weeks for 12 Weeks

Brief Summary:

Primary Objective:

To estimate the efficacy of adjuvant ipilimumab therapy in completely resected Merkel cell carcinoma (MCC) patients; i.e. the primary endpoint is disease-free survival (DFS) rate at 12 months, defined as the number of patients alive and free of disease at 12 months after randomization divided by the total number of patients randomized.

Secondary Objectives:

To assess safety and additional efficacy parameters of the ipilimumab treatment in MCC, as well as to characterize potential biomarkers; secondary endpoints are: (i) adverse events according to CTCAE (Common Terminology Criteria for Adverse Events), Version 4.0 criteria, that are definitely, probably, or possibly related to the administration of ipilimumab, (ii) Overall survival rate at 12 months, defined as the number of patients surviving at 12 months after randomization divided by the total number of patients randomized.


Detailed Summary:

Merkel cell carcinoma (MCC) is a rare (incidence of 0.44 per 100,000), highly aggressive form of skin cancer. Indeed, MCC has a dramatically higher mortality rate after initial diagnosis than malignant melanoma (37 vs. 15 percent). This high mortality rate is largely due to the fact that to date there is no established adjuvant therapy for completely resected MCC, and none of the currently available therapeutic interventions is able to improve overall survival of patients suffering from metastatic disease. Consequently, new therapeutic strategies both for the adjuvant as well as the palliative setting are needed. Recently, the European Commission granted a clinical trial for metastatic MCC within the FP7 HEALTH2011.2.4.1-1 call. The present proposal aims at using this newly established network to investigate an adjuvant immune therapy for MCC.

Epidemiologic data suggest that there are approximately 2500 new MCC cases per year within the EU (European Union), more than 1000 of these patients will die from their disease. MCC usually affects the elderly. The median age at diagnosis is 70 years, and there is a 5- to 10-fold increase in incidence after age 70 as compared with an age less than 60 years. Thus, with an ageing European population the impact of this deadly cancer will increase.

As compared to most cancers, MCC is particularly linked to immune suppression. Indeed, 7.8% of MCC patients are profoundly immune suppressed, with a 16-fold over-representation of MCC compared with the normal incidence. Notably, the impact of immune surveillance on the course of MCC is much more pronounced than on that of melanoma: while the ratio of melanoma to MCC is 60:1 in the normal population, it is 6:1 in the immune suppressed population. Moreover, there are more than 20 reported cases of complete spontaneous regressions of confirmed MC
Sponsor: Prof. Dr. med. Dirk Schadendorf

Current Primary Outcome: Disease-free survival (DFS) rate at 12 months [ Time Frame: 1 year post last patient first treatment/randomization ]

The number of patients alive and free of disease at 12 months after randomization divided by the total number of patients randomized.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of adverse events [ Time Frame: 1 year post last patient first treatment/randomization ]
    Adverse events according to CTCAE, Version 4.0 criteria, that are related to the administration of Ipilimumab
  • Overall survival rate at 12 months [ Time Frame: 1 year post last patient first treatment/randomization ]
    Overall survival rate at 12 months, defined as the number of patients alive at 12 months after randomization divided by the total number of patients randomized.


Original Secondary Outcome: Same as current

Information By: University Hospital, Essen

Dates:
Date Received: June 20, 2014
Date Started: June 2014
Date Completion: June 2018
Last Updated: September 12, 2016
Last Verified: September 2016