Study of the Drug Ipilimumab for Metastatic Merkel Cell Carcinoma

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01913691
Phase
PHASE2
Status
Withdrawn

Conditions

  • Merkel Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
    Ipilimumab is a recombinant, human monoclonal antibody that binds to CTLA-4. It is commercially available under the brand name Yervoy . The use of ipilimumab for MCC is investigational: a study-specific supply of medication will be provided by Bristol-Myers Squibb.

Study Details

Background: \- Ipilimumab is a drug used to treat melanoma that cannot be treated surgically. It targets a molecule found on T-cells in the human immune system. Blocking these molecules on the T-cells might allow the cells to help destroy melanoma cells more effectively. This drug has also been studied in other cancers such as prostate cancer and lung cancer, but not yet in Merkel cell carcinoma (MCC). Researchers think therapy like ipilimumab that enhances the immune system may be effective against MCC. They want to study how safe the drug is and its effect on the immune system and tumors. Objectives: \- To determine the number of subjects with MCC who take the study drug that remain alive 12 months later. Eligibility: \- Adults 18 years and older who have metastatic MCC. Design: * Participants will be screened with a medical history and physical exam. * Participants will receive the study drug 4 times, one dose every 21 days. After the 4 visits, participants will receive a maintenance dose of the drug every 12 weeks until the drug is no longer beneficial. * They will receive the drug through a plastic tube usually inserted in a vein on the arm. * It will take 90 minutes to give each dose. * At all visits, participants will be screened with a medical history, physical exam, and blood tests. Any tumors on their skin will be measured and photographed. * Every 12 weeks during the study and maintenance period, participants will have a CT scan. Throughout the study and maintenance period, they will have blood and skin tests.

Key Dates

Start date
Jul 9, 2013
Status verified
Feb 2014
Primary completion
Feb 3, 2014
Completion
Feb 3, 2014

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Overall survival at 12 months with ipilimumab treatment. [ Time Frame: 1 year ]

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