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NCT04432597 · OUTCOME

Phase II: Safety - Number of Treatment-related Serious Adverse Events (AE) of Grades 1, 2, 3, 4 and/or 5 Along With the AE Term

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
Adverse events
Interval / dispersion
Not reported
Time frame
Date treatment consent signed up to 28 days after last treatment

What was measured

Phase II: Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. All participants who receive any investigational treatment will be evaluable for safety and toxicity evaluations.

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

Any Grade 1
Values in Adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase II Cohort 2, Arm 2A, Dose Level 20Not reportedNot reportedNot reportedNot reported
Any Grade 2
Values in Adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase II Cohort 2, Arm 2A, Dose Level 20Not reportedNot reportedNot reportedNot reported
Any Grade 3
Values in Adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase II Cohort 2, Arm 2A, Dose Level 20Not reportedNot reportedNot reportedNot reported
Any Grade 4
Values in Adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase II Cohort 2, Arm 2A, Dose Level 20Not reportedNot reportedNot reportedNot reported
Any Grade 5
Values in Adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase II Cohort 2, Arm 2A, Dose Level 20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Any Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Any Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Any Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Any Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Any Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    units
    Participants
description
Phase II: Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. All participants who receive any investigational treatment will be evaluable for safety and toxicity evaluations.
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
Date treatment consent signed up to 28 days after last treatment
title
Phase II: Safety - Number of Treatment-related Serious Adverse Events (AE) of Grades 1, 2, 3, 4 and/or 5 Along With the AE Term
type
SECONDARY
unit Of Measure
Adverse events

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

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