Trial Outcomes & Findings for E7 TCR Cell Induction Immunotherapy for Stage II and Stage III HPV-Associated Oropharyngeal Cancer (NCT NCT04015336)

E7 TCR Cell Induction Immunotherapy for Stage II and Stage III HPV-Associated Oropharyngeal Cancer

Fraction of participants who can receive induction therapy with E7 T-Cell receptor (TCR) cells without failing the feasibility criteria with 95% confidence intervals. The feasibility criteria is defined as follows, 1) delivery of the E7 TCR T Cell induction therapy without an increase in tumor T or N stage between baseline and the last response assessment before referral for definitive treatment, 2) initiation of definitive therapy without a delay in treatment related to toxicity of the induction therapy, and 3) if any participant starts the conditioning regimen chemotherapy but does not receive the E7 TCR T Cells it will be considered a feasibility failure. Failure by one criterion will be scored as a feasibility failure.

Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.