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The New NCI Precision Medicine Trials

Lyndsay N Harris1, Charles D Blanke2, Harry P Erba3

  • 1Division of Cancer Treatment and Diagnosis, NCI, Bethesda, Maryland.

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
|August 2, 2023
PubMed

Insights

Master protocols like NCI-MATCH advanced precision oncology. Newer NCI trials (ComboMATCH, iMATCH, myeloMATCH) explore targeted therapy combinations to improve metastatic disease control in cancer.

Area of Science:

  • Oncology
  • Precision Medicine
  • Clinical Trial Design

Background:

  • Master protocols, including basket, umbrella, and platform trials, have gained prominence for studying precision medicine in oncology over the past decade.
  • First-generation trials, such as NCI-MATCH (Molecular Analysis for Therapy Choice), demonstrated the feasibility of large-scale targeted therapy research from both laboratory and clinical viewpoints.
  • Single-agent targeted therapies have demonstrated limited efficacy in controlling metastatic cancer, even with precise drug-target matching.

Purpose of the Study:

  • To introduce and discuss the design and necessary infrastructure for three second-generation precision medicine trials initiated by the NCI.
  • To address the limitations of single-agent targeted therapies by exploring newer approaches involving combinations of targeted therapies or targeted therapy with standard treatments.
  • To advance the field of precision oncology by developing innovative clinical trial designs for combination therapies.

Main Methods:

  • Discussion of the design principles behind the new NCI-led precision medicine trials: ComboMATCH, iMATCH, and myeloMATCH.
  • Exploration of the infrastructure requirements for implementing these complex, multi-arm, multi-stage trial designs.
  • Focus on the strategic shift towards combination therapies within a master protocol framework.

Main Results:

  • The abstract does not present specific results but discusses the rationale and design of new trials.
  • Highlights the transition from first-generation single-agent targeted therapy trials to second-generation combination therapy trials.
  • Emphasizes the feasibility and necessity of advanced master protocol designs for future precision oncology research.

Conclusions:

  • Second-generation precision medicine trials are essential to overcome the limitations of single-agent therapies in metastatic cancer.
  • The NCI's new trials (ComboMATCH, iMATCH, myeloMATCH) represent a significant step forward in master protocol design for combination therapies.
  • Effective infrastructure and innovative trial designs are crucial for the successful implementation of large-scale precision oncology studies.

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