Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04287868 · OUTCOME

Number of Participants With Grades 1, 2, 3, 4 and/or 5 Treatment Related Adverse Events

Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies · Source last updated 2026-06-30

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Date treatment consent signed to date off study, approximately 34 months and 20 days.

What was measured

Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. 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.

Analysis population: Pre-specified in the protocol for cohort 1 only. 1/48 participants in cohort 1 was a screening fail.

Groups in this outcome

Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies

Cohort 1, Arm 1, Treatment Assignment Code (TAC) 1: Participants with HPV associated malignancies will receive human papillomavirus (HPV) vaccine every (q) 4 weeks x6, then q3 months (MO) x2 + NHS-IL12 q 4 weeks (wks) + M7824 q 2 wks. PDS0101 will be administered on Day (D)1, D15, D29 followed by booster vaccines every 4 weeks for up to a year. Subcutaneous 1.0mL (2.4mg of total peptide and 3 mg of R-DOTAP (Versamune) injection). M7824 will be administered at a flat dose of 1,200 mg intravenous (IV) (over 1 hour) once every 2 weeks. NHS-IL12 will be administered by subcutaneous (SC) injection every 4 weeks.

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

Analysis denominator · Participants

GroupSource count
Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies47

Reported measurements

Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies45Not reportedNot reportedNot reportedNot reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies42Not reportedNot reportedNot reportedNot reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies25Not reportedNot reportedNot reportedNot reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies1Not reportedNot reportedNot reportedNot reported
Grade 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        45
    title
    Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        42
    title
    Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        25
    title
    Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      47
    units
    Participants
description
Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. 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.
groups
  1. description
    Cohort 1, Arm 1, Treatment Assignment Code (TAC) 1: Participants with HPV associated malignancies will receive human papillomavirus (HPV) vaccine every (q) 4 weeks x6, then q3 months (MO) x2 + NHS-IL12 q 4 weeks (wks) + M7824 q 2 wks. PDS0101 will be administered on Day (D)1, D15, D29 followed by booster vaccines every 4 weeks for up to a year. Subcutaneous 1.0mL (2.4mg of total peptide and 3 mg of R-DOTAP (Versamune) injection). M7824 will be administered at a flat dose of 1,200 mg intravenous (IV) (over 1 hour) once every 2 weeks. NHS-IL12 will be administered by subcutaneous (SC) injection every 4 weeks.
    id
    OG000
    title
    Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies
param Type
COUNT_OF_PARTICIPANTS
population Description
Pre-specified in the protocol for cohort 1 only. 1/48 participants in cohort 1 was a screening fail.
reporting Status
POSTED
time Frame
Date treatment consent signed to date off study, approximately 34 months and 20 days.
title
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Treatment Related Adverse Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice