Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04287868 · OUTCOME

Best Overall Response (BOR) in Checkpoint Naive and Immune Checkpoint Blockade (ICB) Resistant Disease in Participants With Advanced or Metastatic Human Papillomavirus (HPV) Associated Malignancies

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
Every 2 months, up to approximately 10 months

What was measured

BOR is defined as a complete response or partial response assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.

Analysis population: 48 participants were screened for Cohort (C)1, 1 was a screen fail =\> 47 were treated on C1. 3 participants were screened for C2 and were treated on it. 50 participants (47 in C1 and 3 in C2) comprise the complete treated population ("All participants"). As pre-specified by the protocol cohort 2 is not required to be reported independently.

Groups in this outcome

All Participants

Participants with Human Papillomavirus Associated Malignancies (N = 50, 47 from Cohort 1, 3 from Cohort 2)

Participants With Human Papillomavirus 16 (HPV16+) Tumors

Participants with Human Papillomavirus 16 Tumors (HPV16+) from both Cohort 1 and Cohort 2 further stratified by prior immune checkpoint blockade. (N=37; 34 from Cohort 1, 3 from Cohort 2)

Human Papillomavirus 16 Tumors (HPV-16+), Immune Checkpoint Blockade (ICB) - Naive

Participants with tumor testing positive for HPV16 and no previous exposure to an immune checkpoint blockade agent. (N= 8; 7 from Cohort 1, 1 from Cohort 2)

Human Papillomavirus 16 Tumors (HPV-16+), Immune Checkpoint Blockade (ICB) - Resistant

Participants with tumor testing positive for HPV16 and disease progression following prior treatment with immune checkpoint blockade agent. (N= 29; 27 from Cohort 1, 2 from Cohort 2)

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

Analysis denominator · Participants

GroupSource count
All Participants50
Participants With Human Papillomavirus 16 (HPV16+) Tumors37
Human Papillomavirus 16 Tumors (HPV-16+), Immune Checkpoint Blockade (ICB) - Naive8
Human Papillomavirus 16 Tumors (HPV-16+), Immune Checkpoint Blockade (ICB) - Resistant29

Reported measurements

Complete Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants4Not reportedNot reportedNot reportedNot reported
Participants With Human Papillomavirus 16 (HPV16+) Tumors4Not reportedNot reportedNot reportedNot reported
Human Papillomavirus 16 Tumors (HPV-16+), Immune Checkpoint Blockade (ICB) - Naive2Not reportedNot reportedNot reportedNot reported
Human Papillomavirus 16 Tumors (HPV-16+), Immune Checkpoint Blockade (ICB) - Resistant2Not reportedNot reportedNot reportedNot reported
Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants7Not reportedNot reportedNot reportedNot reported
Participants With Human Papillomavirus 16 (HPV16+) Tumors7Not reportedNot reportedNot reportedNot reported
Human Papillomavirus 16 Tumors (HPV-16+), Immune Checkpoint Blockade (ICB) - Naive3Not reportedNot reportedNot reportedNot reported
Human Papillomavirus 16 Tumors (HPV-16+), Immune Checkpoint Blockade (ICB) - Resistant4Not reportedNot reportedNot reportedNot reported
Overall Response rate (CR+PR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants11Not reportedNot reportedNot reportedNot reported
Participants With Human Papillomavirus 16 (HPV16+) Tumors11Not reportedNot reportedNot reportedNot reported
Human Papillomavirus 16 Tumors (HPV-16+), Immune Checkpoint Blockade (ICB) - Naive5Not reportedNot reportedNot reportedNot reported
Human Papillomavirus 16 Tumors (HPV-16+), Immune Checkpoint Blockade (ICB) - Resistant6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        2
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        4
    title
    Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        6
    title
    Overall Response rate (CR+PR)
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    2. group Id
      OG001
      value
      37
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      29
    units
    Participants
description
BOR is defined as a complete response or partial response assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
groups
  1. description
    Participants with Human Papillomavirus Associated Malignancies (N = 50, 47 from Cohort 1, 3 from Cohort 2)
    id
    OG000
    title
    All Participants
  2. description
    Participants with Human Papillomavirus 16 Tumors (HPV16+) from both Cohort 1 and Cohort 2 further stratified by prior immune checkpoint blockade. (N=37; 34 from Cohort 1, 3 from Cohort 2)
    id
    OG001
    title
    Participants With Human Papillomavirus 16 (HPV16+) Tumors
  3. description
    Participants with tumor testing positive for HPV16 and no previous exposure to an immune checkpoint blockade agent. (N= 8; 7 from Cohort 1, 1 from Cohort 2)
    id
    OG002
    title
    Human Papillomavirus 16 Tumors (HPV-16+), Immune Checkpoint Blockade (ICB) - Naive
  4. description
    Participants with tumor testing positive for HPV16 and disease progression following prior treatment with immune checkpoint blockade agent. (N= 29; 27 from Cohort 1, 2 from Cohort 2)
    id
    OG003
    title
    Human Papillomavirus 16 Tumors (HPV-16+), Immune Checkpoint Blockade (ICB) - Resistant
param Type
COUNT_OF_PARTICIPANTS
population Description
48 participants were screened for Cohort (C)1, 1 was a screen fail =\> 47 were treated on C1. 3 participants were screened for C2 and were treated on it. 50 participants (47 in C1 and 3 in C2) comprise the complete treated population ("All participants"). As pre-specified by the protocol cohort 2 is not required to be reported independently.
reporting Status
POSTED
time Frame
Every 2 months, up to approximately 10 months
title
Best Overall Response (BOR) in Checkpoint Naive and Immune Checkpoint Blockade (ICB) Resistant Disease in Participants With Advanced or Metastatic Human Papillomavirus (HPV) Associated Malignancies
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice