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NCT04287868 · OUTCOME

Number of Treatment Related Grades 1, 2, 3, 4 and/or 5 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
NUMBER
Unit
adverse events
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 2 only.

Groups in this outcome

Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy

Cohort 2, Arm 2, Treatment Assignment Code (TAC) 1: Participants with cervical cancer with prior pelvic radiation and boost brachytherapy will receive human papillomavirus (HPV) vaccine + NHS-IL12 + M7824 (MSB0011359C) at reduced doses. 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 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy3

Reported measurements

Grade 1
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy3Not reportedNot reportedNot reportedNot reported
Grade 2
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy3Not reportedNot reportedNot reportedNot reported
Grade 3
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy1Not reportedNot reportedNot reportedNot reported
Grade 4
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy1Not reportedNot reportedNot reportedNot reported
Grade 5
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    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
      3
    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 2, Arm 2, Treatment Assignment Code (TAC) 1: Participants with cervical cancer with prior pelvic radiation and boost brachytherapy will receive human papillomavirus (HPV) vaccine + NHS-IL12 + M7824 (MSB0011359C) at reduced doses. 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 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy
param Type
NUMBER
population Description
Pre-specified in the protocol for cohort 2 only.
reporting Status
POSTED
time Frame
Date treatment consent signed to date off study, approximately 34 months and 20 days.
title
Number of Treatment Related Grades 1, 2, 3, 4 and/or 5 Adverse Events
type
SECONDARY
unit Of Measure
adverse events

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

Preserved source evidence · Not medical advice