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A phase Ib/II study of APG-115 in combination with pembrolizumab in patients with unresectable or metastatic melanomas or advanced solid tumors

  • Tolcher A
  • Fang D
  • Li Y
  • et al.
Annals of Oncology (2019) 30 i2
DOI: 10.1093/annonc/mdz027
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Abstract

Part 1 is a phase Ib standard "3 + 3" design will be employed to determine the MTD of APG-115 by assessing the DLT of APG-115 in combination with pembrolizumab. Part 2 is a Simon two-stage phase II study design. At RP2D of APG-115 in combination with pembrolizumab, approximately 43 patients will be treated with the combination until disease progression, unacceptable toxicity, or another discontinuation criterion is met.

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Tolcher, A. W., Fang, D. D., Li, Y., Tang, Y., Ji, J., Wang, H., … Zhai, Y. (2019). A phase Ib/II study of APG-115 in combination with pembrolizumab in patients with unresectable or metastatic melanomas or advanced solid tumors. Annals of Oncology, 30, i2. https://doi.org/10.1093/annonc/mdz027

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