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NCT04432597 · OUTCOME

Phase II: Overall Survival at 3 Years Compared With Historical Cohort

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
Percentage of participants
Interval / dispersion
Not reported
Time frame
3 years

What was measured

Phase II: Assess if PRGN-2009 results in significantly prolonged survival at three years as compared to the expected 80% three-year historical survival in p16-positive oropharyngeal cancer (OPC) participants. Three-year overall survival will be measured using a Kaplan-Meier curve and will be compared descriptively with the historical benchmark. Participants who receive two doses of PRGN-2009 and go on to receive standard definitive therapy will be evaluable for overall survival assessment.

Groups in this outcome

Phase II Cohort 2, Arm 2A, Dose Level 2

Phase II in newly diagnosed, untreated, locoregional p16-positove oropharyngeal cancer (OPC) (cohort 2) and in newly diagnosed. Arm 2A: HPV vaccine at recommended phase 2 dose (RP2D) as determined at completion of Arm 1A. HPV vaccine at 5x10\^11 Viral Particles (VP).

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

Analysis denominator · Participants

GroupSource count
Phase II Cohort 2, Arm 2A, Dose Level 222

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase II Cohort 2, Arm 2A, Dose Level 295Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        95
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    units
    Participants
description
Phase II: Assess if PRGN-2009 results in significantly prolonged survival at three years as compared to the expected 80% three-year historical survival in p16-positive oropharyngeal cancer (OPC) participants. Three-year overall survival will be measured using a Kaplan-Meier curve and will be compared descriptively with the historical benchmark. Participants who receive two doses of PRGN-2009 and go on to receive standard definitive therapy will be evaluable for overall survival assessment.
groups
  1. description
    Phase II in newly diagnosed, untreated, locoregional p16-positove oropharyngeal cancer (OPC) (cohort 2) and in newly diagnosed. Arm 2A: HPV vaccine at recommended phase 2 dose (RP2D) as determined at completion of Arm 1A. HPV vaccine at 5x10\^11 Viral Particles (VP).
    id
    OG000
    title
    Phase II Cohort 2, Arm 2A, Dose Level 2
param Type
NUMBER
reporting Status
POSTED
time Frame
3 years
title
Phase II: Overall Survival at 3 Years Compared With Historical Cohort
type
SECONDARY
unit Of Measure
Percentage of participants

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

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