Participants
Tumors, tumor, Cancer
ADVERSE EVENT, TUMOR, ADVERSE EVENTS, SOLID TUMORS, TUMORS, ONCOLOGY, CANCER
The study population consists of patients who are HLA-A*02+ with advanced-stage HPV16+ solid tumors. For eligibility HPV16 positivity was determined from circulating free DNA by droplet digital polymerase chain reaction (PCR) analysis or tumor tissue using standard PCR. All eligible patients were retrospectively tested for HPV16 status using PCR. Patients must have progressed after a platinum-based regimen in the adjuvant or recurrent setting. There was no limit to the number of prior lines of treatment a patient could have received. Patients had to have at least one measurable lesion according to Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST 1.1), and a lesion that could be biopsied at screening and on cycle 2, day 8. All subjects had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Adequate organ function and bone marrow reserve were assessed by laboratory measurements within 14 days prior to the leukapheresis. No treatment with any anticancer therapy was allowed within 2 weeks of leukapheresis.Patients who experienced ongoing > Grade 1 adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE V5.0) related to previous treatment with anticancer or investigational therapy that had not resolved (