Study Design and Subjects
hematologic, renal, and hepatic function, vaginal/vulvar) cancer, Tumors, infection, HPV-18 cancer, HPV-associated carcinoma, Cancer
PRIMARY IMMUNODEFICIENCY, CANCER REFRACTORY, SECOND MALIGNANCY, DISEASE, TUMORS, INFECTION, CERVICAL CANCER, ONCOLOGY, PRIMARY TUMOR, AUTOIMMUNE DISEASE, CANCER
This is a single-arm, single institution, open-label phase II trial that evaluated the combination of durvalumab and the HPV E6/E7 therapeutic vaccine MEDI0457 for patients with recurrent, metastatic HPV-associated carcinoma. Participants were treated and evaluated in 1 of 2 cohorts based upon the site of their primary tumor: cervical cancer or non-cervical (anal, penile, or vaginal/vulvar) cancer. Confirmation of an HPV-16 or HPV-18 cancer by a Clinical Laboratory Improvement Amendment (CLIA)-certified laboratory was required due to the HPV-16/HPV-18 specificity of MEDI0457.Participants must have been of 18 years or greater of age; have an advanced cancer refractory to standard therapy; have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; have an Eastern Cooperative Oncology Group performance status of 0 or 1; and have adequate hematologic, renal, and hepatic function. Study participants were not permitted to have received prior corticosteroids or other immunosuppressive medications within 14 days of treatment initiation, nor were they allowed to be taking concurrent therapeutic anticoagulation or irreversible platelet inhibitors (due to repeated intramuscular injections of MEDI0457). Other ineligibility criteria for study participation included a history of primary immunodeficiency, prior antineoplastic immune checkpoint blockade therapy, and active (or prior) autoimmune disease, active infection, and a history of (invasive) second malignancy within 2 years of study entry.Approval for this clinical trial was granted by the Institutional Review Board at The University of Texas MD Anderson Cancer Center. All patients provided written informed consent prior to study entry. The trial was conducted according to the principles of the Declaration of Helsinki.