Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies

Draft scope assessment: unclear. Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

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.

→

secondary · POSTED

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.

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

→

secondary · POSTED

PFS is defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first. Participants who do not have disease progression or have not died at the end of follow up will be censored at the last known date the participant was progression free. Progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions.

Source null

→

secondary · POSTED

OS will be evaluated using Kaplan-Meier methods and is defined as the time from the date of first treatment to the date of death (any cause). Participants who are alive at the end of follow up will be censored at the last known date alive.

Source null

→

secondary · POSTED

Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions.

Source null

→

secondary · POSTED

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.

Pre-specified in the protocol for cohort 2 only.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-rectal-cancer-xeloda-40fbbc7c
nct id: NCT04287868
trial label: Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies
applicability: unclear
applicability note: Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04287868
outcome key
om-0000
source section id
NCT04287868-om-0000
source outcome index
0
endpoint
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
endpoint definition
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.
time origin
Every 2 months, up to approximately 10 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04287868
outcome key
om-0001
source section id
NCT04287868-om-0001
source outcome index
1
endpoint
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Treatment Related Adverse Events
endpoint definition
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.
time origin
Date treatment consent signed to date off study, approximately 34 months and 20 days.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Pre-specified in the protocol for cohort 1 only. 1/48 participants in cohort 1 was a screening fail.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04287868
outcome key
om-0002
source section id
NCT04287868-om-0002
source outcome index
2
endpoint
Progression-Free Survival (PFS) Time
endpoint definition
PFS is defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first. Participants who do not have disease progression or have not died at the end of follow up will be censored at the last known date the participant was progression free. Progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions.
time origin
PFS is defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first, up to 53 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04287868
outcome key
om-0003
source section id
NCT04287868-om-0003
source outcome index
3
endpoint
Overall Survival (OS)
endpoint definition
OS will be evaluated using Kaplan-Meier methods and is defined as the time from the date of first treatment to the date of death (any cause). Participants who are alive at the end of follow up will be censored at the last known date alive.
time origin
The time from the date of first treatment to the date of death (any cause), up to 67 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04287868
outcome key
om-0004
source section id
NCT04287868-om-0004
source outcome index
4
endpoint
Ratio of Participants That Are Hospitalized Because of Adverse Events Attributed to Disease Progression.
endpoint definition
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions.
time origin
While participant on study; an average of 3 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04287868
outcome key
om-0005
source section id
NCT04287868-om-0005
source outcome index
5
endpoint
Number of Treatment Related Grades 1, 2, 3, 4 and/or 5 Adverse Events
endpoint definition
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.
time origin
Date treatment consent signed to date off study, approximately 34 months and 20 days.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Pre-specified in the protocol for cohort 2 only.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04287868
outcome key
om-0000
arm key
OG000
arm label
All Participants
regimen
Participants with Human Papillomavirus Associated Malignancies (N = 50, 47 from Cohort 1, 3 from Cohort 2)
analyzed count
50
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04287868-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04287868
outcome key
om-0000
arm key
OG001
arm label
Participants With Human Papillomavirus 16 (HPV16+) Tumors
regimen
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)
analyzed count
37
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04287868-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04287868
outcome key
om-0000
arm key
OG002
arm label
Human Papillomavirus 16 Tumors (HPV-16+), Immune Checkpoint Blockade (ICB) - Naive
regimen
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)
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04287868-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04287868
outcome key
om-0000
arm key
OG003
arm label
Human Papillomavirus 16 Tumors (HPV-16+), Immune Checkpoint Blockade (ICB) - Resistant
regimen
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)
analyzed count
29
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04287868-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04287868
outcome key
om-0001
arm key
OG000
arm label
Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies
regimen
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.
analyzed count
47
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04287868-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04287868
outcome key
om-0002
arm key
OG000
arm label
Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies
regimen
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.
analyzed count
47
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04287868-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04287868
outcome key
om-0002
arm key
OG001
arm label
Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04287868-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04287868
outcome key
om-0003
arm key
OG000
arm label
Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies
regimen
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.
analyzed count
47
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04287868-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04287868
outcome key
om-0003
arm key
OG001
arm label
Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04287868-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04287868
outcome key
om-0004
arm key
OG000
arm label
Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies
regimen
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.
analyzed count
47
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04287868-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04287868
outcome key
om-0004
arm key
OG001
arm label
Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04287868-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04287868
outcome key
om-0005
arm key
OG000
arm label
Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04287868-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04287868
harm key
EG000
source section id
NCT04287868-ae
event group key
EG000
event group label
Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies
serious affected
18
serious at risk
47
other affected
47
other at risk
47
frequency threshold
0
collection period
Date treatment consent signed to date off study, approximately 34 months and 20 days.
event definition
1/48 participants in cohort 1 was a screening fail.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04287868
harm key
EG001
source section id
NCT04287868-ae
event group key
EG001
event group label
Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Date treatment consent signed to date off study, approximately 34 months and 20 days.
event definition
1/48 participants in cohort 1 was a screening fail.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice