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NCT04432597 · OUTCOME

Phase I: 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 to date off study, an average of 6 months

What was measured

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 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

Any Grade 1
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cohort 1, Arm 1A, Dose Level 10Not reportedNot reportedNot reportedNot reported
Phase I Cohort 1A, Arm 1A, Dose Level 20Not reportedNot reportedNot reportedNot reported
Phase I Cohort 1, Arm 1B, Dose Level 20Not reportedNot reportedNot reportedNot reported
Any Grade 2
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cohort 1, Arm 1A, Dose Level 10Not reportedNot reportedNot reportedNot reported
Phase I Cohort 1A, Arm 1A, Dose Level 20Not reportedNot reportedNot reportedNot reported
Phase I Cohort 1, Arm 1B, Dose Level 20Not reportedNot reportedNot reportedNot reported
Grade 3 Duodenal hemorrhage
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cohort 1, Arm 1A, Dose Level 10Not reportedNot reportedNot reportedNot reported
Phase I Cohort 1A, Arm 1A, Dose Level 20Not reportedNot reportedNot reportedNot reported
Phase I Cohort 1, Arm 1B, Dose Level 21Not reportedNot reportedNot reportedNot reported
Grade 4 Duodenal hemorrhage
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cohort 1, Arm 1A, Dose Level 10Not reportedNot reportedNot reportedNot reported
Phase I Cohort 1A, Arm 1A, Dose Level 20Not reportedNot reportedNot reportedNot reported
Phase I Cohort 1, Arm 1B, Dose Level 21Not reportedNot reportedNot reportedNot reported
Grade 4 Pharyngeal mucositis
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cohort 1, Arm 1A, Dose Level 10Not reportedNot reportedNot reportedNot reported
Phase I Cohort 1A, Arm 1A, Dose Level 20Not reportedNot reportedNot reportedNot reported
Phase I Cohort 1, Arm 1B, Dose Level 21Not reportedNot reportedNot reportedNot reported
Any Grade 5
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Cohort 1, Arm 1A, Dose Level 10Not reportedNot reportedNot reportedNot reported
Phase I Cohort 1A, Arm 1A, Dose Level 20Not reportedNot reportedNot reportedNot reported
Phase I Cohort 1, Arm 1B, Dose Level 20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Any Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Any Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Grade 3 Duodenal hemorrhage
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Grade 4 Duodenal hemorrhage
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Grade 4 Pharyngeal mucositis
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Any Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      11
    units
    Participants
description
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 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
NUMBER
reporting Status
POSTED
time Frame
Date treatment consent signed to date off study, an average of 6 months
title
Phase I: Safety - Number of Treatment-related Serious Adverse Events (AE) of Grades 1, 2, 3, 4 and/or 5 Along With the AE Term
type
PRIMARY
unit Of Measure
adverse events

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

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