Skip to content
TriangleGet started
← Full study record

NCT04432597 · OUTCOME

Phase I: Recommended Phase II Dose of PRGN-2009

HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers · Source last updated 2026-08-18

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

Measure
NUMBER
Unit
viral particles (VP)
Interval / dispersion
Not reported
Time frame
Date treatment consent signed to date off study, approximately 18 months

What was measured

Phase I: To determine the recommended phase II dose (RP2D) of PRGN-2009 Human Papillomavirus Vaccine (HPV) vaccine alone or in combination with M7824 (MSB0011359C). Recommended Phase 2 Dose, the dose of a drug or drug combination that was identified in a Phase 1 study (dose finding study) that was identified for continued study.

Groups in this outcome

All Participants in Phase I

All Participants in phase I who received at least one dose of Monotherapy Human Papillomavirus Vaccine (HPV) vaccine at 1x10\^11 Viral Particles (VP) and/or plus bintrafusp alfa 1200 mg.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
All Participants in Phase I17

Reported measurements

Source class 1
Values in viral particles (VP) · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants in Phase I500,000,000,000Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        500,000,000,000
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    units
    Participants
description
Phase I: To determine the recommended phase II dose (RP2D) of PRGN-2009 Human Papillomavirus Vaccine (HPV) vaccine alone or in combination with M7824 (MSB0011359C). Recommended Phase 2 Dose, the dose of a drug or drug combination that was identified in a Phase 1 study (dose finding study) that was identified for continued study.
groups
  1. description
    All Participants in phase I who received at least one dose of Monotherapy Human Papillomavirus Vaccine (HPV) vaccine at 1x10\^11 Viral Particles (VP) and/or plus bintrafusp alfa 1200 mg.
    id
    OG000
    title
    All Participants in Phase I
param Type
NUMBER
reporting Status
POSTED
time Frame
Date treatment consent signed to date off study, approximately 18 months
title
Phase I: Recommended Phase II Dose of PRGN-2009
type
PRIMARY
unit Of Measure
viral particles (VP)

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

Preserved source evidence · Independent clinical review pending · Not medical advice