All fourteen rectal cancer patients in a small phase II study of dostarlimab, an anti-PD-1 monoclonal antibody, saw their cancer completely disappear—with no progression or recurrence at follow-up six to 25 months later. None of the patients required further chemotherapy, radiation, or surgery.
NIH announced Jan. 29 that “Basic Experimental Studies Involving Humans,” also called BESH, will no longer be considered clinical trials and will therefore no longer be subject to the requirements under the NIH definition of a clinical trial, including registration and reporting requirements in ClinicalTrials.gov.
