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Design Considerations for Early Phase Trials of Immuno-oncology Drugs

Ever since the first immune checkpoint inhibitor was approved for market nearly twelve years ago, the industry has witnessed a steady rise in the search for new immunotherapies. This has aligned with the broader curation of a number of new dose-escalation and efficacy designs for clinical development in oncology.

Hastening the search for novel treatment options therefore benefits from exploration of how these complex early and late-phase designs interact with each other, and what special design considerations can be implemented in early phases of clinical research for strategic late-phase clinical development. A nuanced understanding of these considerations enables sponsors to ask more complex questions like:

  • Which dose-escalation designs are best suited for trials where the new treatment aspires to join a basket trial in later phases?
  • Is data acquired using a complex early phase design like BLRM, TITE-BOIN, or dual-agent escalation recommended for use if a seamless design will thereafter be used to confirm efficacy?
  • What are the adaptive strategies that best serve specific trials?

A recent webinar by Cytel’s Michael Fossler and James Matcham reviews the various trial design considerations confronting modern immunotherapy sponsors. After introducing the relative benefits of a number of algorithm-based and model-based escalation designs, Fossler and Matcham dive into strategic uses of target population, clinical pharmacology considerations, and exposure-response modeling for efficient clinical development.

Taken together, these questions can help sponsors have more in-depth conversations with their statistical design consultants about specific adaptive design and modeling strategies for their immunotherapies.

Watch the full webinar, “Design Considerations for Early Phase Clinical Trials of Immuno-oncology Drugs,” here:


Watch the Webinar


Bayesian topics are frequently featured in Cytel’s Perspectives on Enquiry and Evidence. Our new eBook features a set of articles exploring various topics related to Bayesian statistical methods.


Read more on Bayesian methods in Perspectives on Enquiry and Evidence:

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