Phase II Study of Nivolumab in Combination With Ipilimumab for Uveal Melanoma
The goal of this clinical research study is to learn if ipilimumab and nivolumab can help to control uveal melanoma.
Ipilimumab is designed to increase the immune system's ability to fight cancer.
Nivolumab is an antibody (a protein that attacks foreign cells) that is designed to allow the body's immune system to work against tumor cells.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Nivolumab in Combination With Ipilimumab for Uveal Melanoma|
- Overall Response Rate [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Response defined as those patients who achieve RECIST complete response plus partial response (CR + PR). Overall response applied for interpreting the criteria of the Simon two-stage design.
- Progression-Free Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]Kaplan-Meier method used to assess the distribution of time-to-event variables, including overall survival, progression-free survival, and landmark analysis where possible.
|Study Start Date:||November 2012|
|Estimated Primary Completion Date:||November 2017 (Final data collection date for primary outcome measure)|
Experimental: Nivolumab + Ipilimumab
Nivolumab 1 mg/kg plus Ipilimumab 3 mg/kg (+/- 7 days) for total of four doses (week 1, 4, 7, 10), continues through week 12.
For participants with no disease progression or unmanageable toxicity by week 12, Nivolumab monotherapy 3 mg/kg every 2 weeks until disease progression or unmanageable toxicity.
1 mg/kg by vein for a total of four doses (week 1, 4, 7, 10). The induction phase continues through week 12.
Other Names:Drug: Ipilimumab
3 mg/kg by vein for a total of four doses (week 1, 4, 7, 10). The induction phase continues through week 12.
For patients who have not experienced disease progression or unmanageable toxicity by week 12:
Nivolumab 3 mg/kg by vein every 2 weeks until disease progression or unmanageable toxicity as deemed by the clinical investigator.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01585194
|Contact: Sapna P. Patel, MD||713-792-2921|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sapna P. Patel, MD||M.D. Anderson Cancer Center|