Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

June 9, 2020

Primary Completion Date

July 26, 2022

Study Completion Date

July 1, 2026

Conditions
Cervical CancerHPV CancersAnal CancerOropharyngeal CancerVulvar, Vaginal, Penile, Rectal Cancer
Interventions
BIOLOGICAL

PDS0101

PDS0101 will be administered on Day (D)1, D15, D29 followed by booster vaccines every 4 weeks for up to a year. Subcutaneous 1.0mL (2.4mg of total peptide and 3 mg of R-DOTAP) injection.

BIOLOGICAL

M7824

M7824 will be administered at a flat dose of 1,200 mg intravenous (IV) (over 1 hour) once every 2 weeks.

BIOLOGICAL

NHS-IL12

NHS-IL12 will be administered at as dose of potentially de-escalating doses by subcutaneous (SC) injection every 4 weeks.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH