Participant flow

Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies · Source last updated 2026-06-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Cohort 1, Arm 1, Treatment Assignment Code (TAC) 1: Participants with HPV associated malignancies will receive human papillomavirus (HPV) vaccine every (q) 4 weeks x6, then q3 months (MO) x2 + NHS-IL12 q 4 weeks (wks) + M7824 q 2 wks. 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 (Versamune) injection). M7824 will be administered at a flat dose of 1,200 mg intravenous (IV) (over 1 hour) once every 2 weeks. NHS-IL12 will be administered by subcutaneous (SC) injection every 4 weeks.

   id

   FG000

   title

   Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies

2. description

   Cohort 2, Arm 2, Treatment Assignment Code (TAC) 1: Participants with cervical cancer with prior pelvic radiation and boost brachytherapy will receive human papillomavirus (HPV) vaccine + NHS-IL12 + M7824 (MSB0011359C) at reduced doses. 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 (Versamune) injection). M7824 will be administered at a flat dose of 1,200 mg intravenous (IV) (over 1 hour) once every 2 weeks. NHS-IL12 will be administered by subcutaneous (SC) injection every 4 weeks.

   id

   FG001

   title

   Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Screening fail

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         48

      2. group Id

         FG001

         num Subjects

         3

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         47

      2. group Id

         FG001

         num Subjects

         3

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice