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To assess the efficacy of G100 in combination with pembrolizumab.

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Trial Profile

To assess the efficacy of G100 in combination with pembrolizumab.

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 21 Oct 2018

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At a glance

Most Recent Events

  • 11 Oct 2018 According to Immune Design media release, to accelerate enrollment in this study, the company plans to use both an open IND and submit a new IND for this specific unmet medical need population, as requested by the FDA. Based on existing ORR data, approximately 100 patients may be required. The final sample size will be adapted depending on the ORR observed in the initial patients.
  • 08 Aug 2018 New trial record
  • 01 Aug 2018 According to Immune Design media release, Immune Design is working with the FDA on the details of the study and plans to initiate patient enrollment as soon as feasible after the protocol is finalized.The company intends to use this open label approach to generate data for a potential biological license application and plans to provide an update on the final study design and associated timeline after the ongoing FDA discussions are complete.

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