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Clinical Trial 18536
Interventions:IL-2 (Interleukin-2); Pembrolizumab (Keytruda)
Study Type: Treatment
Phase of Study: Phase II
- Mayer Fishman
Coordinated High Dose Interleukin-2 (aldesleukin, Proleukin) and Pembrolizumab (anti-PD1, Keytruda) for Therapy of Metastatic Kidney Cancer
The main purpose of this study is to evaluate the effects of the interleukin-2 given in combination with pembrolizumab. Interleukin-2 (IL-2) is also called aldesleukin, or Proleukin¿. Pembrolizumab is also called Keytruda¿, or anti-PD-1 antibody.
Primary Objective & Hypothesis - Objective: Estimate the frequencies of disease response so as to be a basis to commit to more development of this schedule. Note that this is framed broadly, with the understanding that the decision to commit to further development of the schedule includes a variety of feasibility endpoints. The ORR will be defined as the CR + PR patients, with confirmation of the response status (numerator), among those receiving at least the first IL-2 dose, of cycle B2 (denominator). Hypothesis: H0: ORR is 45%. Thus, a 45% ORR (CR + PR) would be considered of definite interest for further development, contingent on the feasibility assessment as well as part of the decision. This is the hypothesis technically driving the sample size: With N= 21, and the exact binomial one-sided á = .0431 and the power = .8029. (The actual testing will be computed using the actual enrollment, by the study statistician.). Secondary Objectives & Hypotheses - Objective: Feasible improvement of CR rate. Hypothesis: The study is not powered for a definitive assessment, but >15% CR would be of interest. Objective: This is an exploratory safety objective: OS will be not demonstrably inferior to contemporary subjects with matched clinical risk features from PROCLAIM database observed OS (using p > .05). Hypothesis: H0: OS[1-year] is more than 20% lower than matched controls HA: ORR is same or better (using p > .05).