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NCT04432597 · OUTCOME

Phase I: Overall Survival (OS)

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
MEDIAN
Unit
Months
Interval / dispersion
Full Range
Time frame
The time from the date of first treatment to the date of death (any cause), an average of 12 months

What was measured

Phase I: Overall survival assessed using the Kaplan-Meier method, defined as the time from the date of first treatment to the date of death (any cause). Participants who are alive at the end of follow up will be censored at the last known date alive.

Groups in this outcome

Phase I Cohort 1, Arm 1A, Dose Level 1

Phase I, Dose Level 1 in recurrent/metastatic (R/M) Human Papillomavirus Vaccine (HPV) associated cancers (cohort 1). Arm 1A: Monotherapy HPV vaccine, Dose escalation. HPV vaccine at 1x10\^11 Viral Particles (VP).

Phase I Cohort 1A, Arm 1A, Dose Level 2

Phase I, Dose Level 2 in recurrent/metastatic (R/M) Human Papillomavirus Vaccine (HPV) associated cancers (cohort 1). Arm 1A: Monotherapy HPV vaccine, Dose escalation. HPV vaccine at 5x10\^11 Viral Particles (VP).

Phase I Cohort 1, Arm 1B, Dose Level 2

Phase I in recurrent/metastatic (R/M) Human Papillomavirus Vaccine (HPV) associated cancers (cohort 1). Arm 1B: Combination: HPV vaccine at recommended phase 2 dose (RP2D) as determined at completion of Arm 1A plus bintrafusp alfa 1200 mg. 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 I Cohort 1, Arm 1A, Dose Level 13
Phase I Cohort 1A, Arm 1A, Dose Level 23
Phase I Cohort 1, Arm 1B, Dose Level 211

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase I Cohort 1, Arm 1A, Dose Level 120.4Not reported2.926.8Not reported
Phase I Cohort 1A, Arm 1A, Dose Level 27.0Not reported6.57.8Not reported
Phase I Cohort 1, Arm 1B, Dose Level 219.1Not reported0.555.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.9
        upper Limit
        26.8
        value
        20.4
      2. group Id
        OG001
        lower Limit
        6.5
        upper Limit
        7.8
        value
        7.0
      3. group Id
        OG002
        lower Limit
        0.5
        upper Limit
        55.2
        value
        19.1
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      11
    units
    Participants
description
Phase I: Overall survival assessed using the Kaplan-Meier method, defined as the time from the date of first treatment to the date of death (any cause). Participants who are alive at the end of follow up will be censored at the last known date alive.
dispersion Type
Full Range
groups
  1. description
    Phase I, Dose Level 1 in recurrent/metastatic (R/M) Human Papillomavirus Vaccine (HPV) associated cancers (cohort 1). Arm 1A: Monotherapy HPV vaccine, Dose escalation. HPV vaccine at 1x10\^11 Viral Particles (VP).
    id
    OG000
    title
    Phase I Cohort 1, Arm 1A, Dose Level 1
  2. description
    Phase I, Dose Level 2 in recurrent/metastatic (R/M) Human Papillomavirus Vaccine (HPV) associated cancers (cohort 1). Arm 1A: Monotherapy HPV vaccine, Dose escalation. HPV vaccine at 5x10\^11 Viral Particles (VP).
    id
    OG001
    title
    Phase I Cohort 1A, Arm 1A, Dose Level 2
  3. description
    Phase I in recurrent/metastatic (R/M) Human Papillomavirus Vaccine (HPV) associated cancers (cohort 1). Arm 1B: Combination: HPV vaccine at recommended phase 2 dose (RP2D) as determined at completion of Arm 1A plus bintrafusp alfa 1200 mg. HPV vaccine at 5x10\^11 Viral Particles (VP).
    id
    OG002
    title
    Phase I Cohort 1, Arm 1B, Dose Level 2
param Type
MEDIAN
reporting Status
POSTED
time Frame
The time from the date of first treatment to the date of death (any cause), an average of 12 months
title
Phase I: Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

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