The didactic training is structured as modules, each consisting of a two-hour reading period and a one-on-one didactic session led by an expert in the topic. A concise reading syllabus will be provided, which will include contemporary literature (review articles and seminal original research articles), as well as Earle A. Chiles Research Institute clinical trial protocols in immuno-oncology.
For the one-on-one didactic sessions, fellows will receive interactive but formalized lectures on the topic and will also discuss the key points highlighted by the reading materials. This curriculum is designed to allow the fellow to ask questions in real-time pertaining to the subject at hand in a stress-free setting, allowing for an accelerated and customized learning experience.
The curriculum consists of 9 major units.
Unit 1: Basic tumor immunology
Unit 2: Categories of immunotherapy
Unit 3: Immune monitoring approaches
Unit 4: From bench to bedside: translational approaches
Unit 5: Clinical immunotherapeutics
Unit 6: Immunotherapy clinical trials design
Unit 7: Clinical trials monitoring and conduct
Unit 8: Tumor-specific immunologic considerations
Unit 9: Practicalities of immuno-oncology research
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Practicums will be curated by the assigned faculty advisor for each of the units. Examples of practicums for each of the units are listed below.
Unit 1: Basic tumor immunology
Unit 2: Categories of immunotherapy
Unit 3: Immune monitoring approaches
Unit 4: From bench to bedside: translational approaches
Unit 5: Clinical immunotherapeutics
Unit 6: Immunotherapy clinical trials design
Unit 7: Clinical trials monitoring and conduct
Unit 8: Tumor-specific immunologic considerations
Unit 9: Practicalities of immuno-oncology research
The following are examples of research projects available for I-O fellows.
Domain 1: Clinical Trials Development
Target dates:
September – Formalize a clinical trial concept
December – Draft of clinical trial finalized
March – Apply to the AACR trials workshop
July – Attend the AACR trials workshop
Fellows will be assisted by their mentor in identifying a clinical trial concept, developing the concept with collaborators (biostatisticians, patient advocate panel, translational scientists), and writing the clinical protocol to completion. With this concept, they are urged to mount an application to the AACR/ASCO Methods in Clinical Research Workshop in Colorado, due mid-March. If successful, they will attend the week-long workup at the conclusion of their fellowship in July, and will be sponsored for travel by the fellowship program.
Because clinical trials require several years to complete, fellows should not expect to see their trial to completion during the fellowship period, but will be acknowledged as a co-author when the trial has concluded, and are urged to submit the clinical trial as a “Trials in Progress” abstract/poster at an international meeting such as the ASCO Annual Meeting or the SITC Annual Meeting.
Domain 2: Translational Biomarkers Development
Target dates:
September – Formulate a hypothesis and identify specimens
December – Conduct assay
March – Complete analysis
June – Submit for publication of abstract presentation
Fellows will be assisted in identifying biospecimens from a clinical trial or an IRB-approved retrospective specimen collection, and choosing a rationally-selected immune-based biomarker for analysis of these biospecimens. The goal is to use a translational approach (i.e. multispectral immunofluorescence or RNA transcriptional analysis) to describe the effect of immunotherapy in a cohort of patients, or to evaluate potential predictive/prognostic biomarkers in the setting of a particular disease setting.
The fellow will collaborate with expert scientists in the chosen biomarker, biostatisticians, as well as expert clinicians in the tumor type of interest. The fellow will be urged to submit the results for abstract presentation or publication.
Domain 3: Literature Review
Target dates:
September – Select a topic and identify target population
December – Collect and read all relevant literature
March – Solicit draft review to faculty for revisions
May – Submit review for final publication
To develop expertise in an immuno-oncologic sub-specialty and to demonstrate proficiency in manuscript writing, the fellow will be urged to write a literature review on an immuno-oncology topic for publication in a peer-reviewed journal. The fellow will be advised on appropriate topics and target publications, but ultimately will choose a topic of interest to them. Examples of topics include “microbiome assessment as a potential predictive biomarker in immune checkpoint blockade” or “emerging immunotherapy strategies for the treatment of hormone receptor positive breast cancer.
