HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers

On the phase I portion of the protocol PRGN-2009 will be administered on Day (D)1, D15, D29 followed by booster vaccines every 4 weeks for up to a year. The dose level given as booster will be the same dose participants will be receiving for D1, D15 and D29.

On the phase II portion of the protocol PRGN-2009 will be administered on just Day (D)1 and D15.

"Subjects enrolled to Arm 1B will receive M7824 (MSB0011359C) via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a flat dose of 1,200 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter."

MRI (with gadolinium) of the neck, chest, skull, and/or sinonasal, if indicated, will be used when computed tomography (CT) scan is not an option to follow the disease.

Bone scans and other imaging assessments may also be performed as clinically indicated.

Imaging of the neck, chest, skull, and/or sinonasal, if indicated, will be performed every 8 weeks. In the event of a partial response (PR) or complete response (CR) tumor imaging assessments may be performed every 3 months (+/- 2 weeks) at the discretion of the investigator.

Performed at baseline and may also be performed as clinically indicated by development of new specific symptoms or on the discretion of the Principal Investigator.

Performed at baseline and may also be performed as clinically indicated by development of new specific symptoms or on the discretion of the Principal Investigator.

"Where feasible, optional biopsies may be done at baseline as well as at week 9 and will likely be computed tomography (CT) guided. If a recent (≤ 6 months preferred) outside biopsy has been performed that specimen may be used in lieu of a baseline biopsy for phase I participants.~For participants with lesions amenable to biopsy, two biopsies may be performed at baseline and at Week 9 (phase I participants)."

"Where feasible, biopsies will be done at baseline as well as at week 4-5. Biopsies will be done by ear, nose and throat (ENT) under direct visualization. Where feasible at least 2 cores will be obtained. If a recent (≤ 6 months preferred) outside biopsy has been performed that specimen may be used in lieu of a baseline biopsy.~For participants with lesions amenable to biopsy, two biopsies may be performed at baseline and at Week 4-5 (phase II participants)."