Carcinoma, Renal Cell Clinical Trial
Official title:
A Phase I/II Study to Assess the Safety and Efficacy of Pazopanib and MK 3475 in Patients With Advanced Renal Cell Carcinoma
This is an open-label, 2 part study of pazopanib and/or MK 3475 in treatment naïve subjects
with advanced RCC. Part 1 consists of a Phase I dose escalation of pazopanib + MK 3475
followed by an expansion cohort to determine the maximum tolerated regimen and the
recommended Phase II dose. Part 2 is a randomized 3-arm Phase II study to evaluate the
clinical efficacy and safety of pazopanib + MK 3475 as compared to single-agent pazopanib and
single-agent MK 3475. The objectives of this Phase I/II study are to test the safety and
tolerability of pazopanib in combination with MK 3475, and study the clinical efficacy of
pazopanib in combination with MK 3475 in subjects with advanced RCC as compared with
single-agent pazopanib and single-agent MK 3475.
Following the Urgent Safety Measure (USM) released on February 09, 2017, the phase II (Part
2) portion of this study will not commence.
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