Table 1

Examples of biospecimen source, timing and evaluable endpoints

Biospecimen collection timeBiospecimenEvaluable endpoints
PretreatmentTumorBiomarker of response to therapy
Blood or other normal tissueBiomarker of host genomics
MicrobiomeBiomarker of interface of human tissues and microbiome
On-treatmentTumorUseful in assessing impact of a therapy if compared with on-treatment tumor in a control arm
Lymph nodeDetermine immune response to cancer vaccine or intratumoral therapy, or impact of therapy on antigen presenting cells, compared with a control arm
Pretreatment and on-treatmentTumorDetermination of treatment-induced changes in tumor microenvironment
BloodDetermination of treatment-induced changes in host immune response
At time of progressionTumorMay suggest mechanisms of immune escape