Phase II Study of Nivolumab in Combination With Ipilimumab for Uveal Melanoma
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|ClinicalTrials.gov Identifier: NCT01585194|
Recruitment Status : Recruiting
First Posted : April 25, 2012
Last Update Posted : May 23, 2018
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.
This is an investigational study.
Ipilimumab is FDA approved and commercially available to treat metastatic melanoma, including uveal melanoma. Nivolumab is FDA approved and commercially available to treat metastatic melanoma, including uveal melanoma, that has gotten worse while taking ipilimumab. Combining these 2 drugs to treat of uveal melanoma is investigational.
Up to 39 patients will take part in this study. All will be enrolled at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Uveal Melanoma||Drug: Nivolumab Drug: Ipilimumab||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Nivolumab in Combination With Ipilimumab for Uveal Melanoma|
|Actual Study Start Date :||November 2012|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
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 480 mg every 4 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.
For patients who have not experienced disease progression or unmanageable toxicity by week 12:
Nivolumab 480 mg by vein every 4 weeks until disease progression or unmanageable toxicity as deemed by the clinical investigator.
3 mg/kg by vein for a total of four doses (week 1, 4, 7, 10). The induction phase continues through week 12.
- Overall Response Rate [ Time Frame: 12 weeks ]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 ]Kaplan-Meier method used to assess the distribution of time-to-event variables, including overall survival, progression-free survival, and landmark analysis where possible.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|