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Open-label, randomized, multi-center study comparing the sequence of high dose Aldesleukin (Proleukin ® (HD IL-2) and Ipilimumab Yervoy ® ) in patients with metastatic melanoma (proclivity 02)

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Open-label, randomized, multi-center study comparing the sequence of high dose Aldesleukin (Proleukin® (HD IL-2) and Ipilimumab Yervoy®) in patients with metastatic melanoma (proclivity 02)
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Figure 1: Open-label, randomized, multi-center study comparing the sequence of high dose Aldesleukin (Proleukin® (HD IL-2) and Ipilimumab Yervoy®) in patients with metastatic melanoma (proclivity 02)

Mentions: Adult patients with Stage IV or unresectable Stage III metastatic melanoma who are eligible to receive HD IL-2, treatment naïve or have received prior adjuvant therapy are randomized to a sequential administration of 4 doses of Ipilimumab or 4 cycles of HD IL-2 dosed according to their package inserts (figure 1). Fifty of the patients will start with one drug and 50 the other. The second drug will begin as soon as practically possible, without waiting for relapse. Entry criteria have recently been amended to include prior treatment with anti-PD-1 or anti-PDL-1. Twelve US sites are currently enrolling patients. An independent Data and Safety Monitoring Committee oversees the study. The primary endpoint is the proportional one year survival in the ITT population and a protocol defined population of patients who have received at least half of the planned doses of both study drugs. Clinical response and progression free survival will also be assessed. The primary endpoint is the proportional one year survival in the ITT population and a protocol defined population of patients who have received at least half of the planned doses of both study drugs. Clinical response and progression free survival will also be assessed.


Open-label, randomized, multi-center study comparing the sequence of high dose Aldesleukin (Proleukin ® (HD IL-2) and Ipilimumab Yervoy ® ) in patients with metastatic melanoma (proclivity 02)
Open-label, randomized, multi-center study comparing the sequence of high dose Aldesleukin (Proleukin® (HD IL-2) and Ipilimumab Yervoy®) in patients with metastatic melanoma (proclivity 02)
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4288743&req=5

Figure 1: Open-label, randomized, multi-center study comparing the sequence of high dose Aldesleukin (Proleukin® (HD IL-2) and Ipilimumab Yervoy®) in patients with metastatic melanoma (proclivity 02)
Mentions: Adult patients with Stage IV or unresectable Stage III metastatic melanoma who are eligible to receive HD IL-2, treatment naïve or have received prior adjuvant therapy are randomized to a sequential administration of 4 doses of Ipilimumab or 4 cycles of HD IL-2 dosed according to their package inserts (figure 1). Fifty of the patients will start with one drug and 50 the other. The second drug will begin as soon as practically possible, without waiting for relapse. Entry criteria have recently been amended to include prior treatment with anti-PD-1 or anti-PDL-1. Twelve US sites are currently enrolling patients. An independent Data and Safety Monitoring Committee oversees the study. The primary endpoint is the proportional one year survival in the ITT population and a protocol defined population of patients who have received at least half of the planned doses of both study drugs. Clinical response and progression free survival will also be assessed. The primary endpoint is the proportional one year survival in the ITT population and a protocol defined population of patients who have received at least half of the planned doses of both study drugs. Clinical response and progression free survival will also be assessed.

View Article: PubMed Central - HTML

No MeSH data available.


Related in: MedlinePlus