HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers

Draft scope assessment: unclear. Attached because the study's own record names PD-L1. 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

Phase I: To determine the recommended phase II dose (RP2D) of PRGN-2009 Human Papillomavirus Vaccine (HPV) vaccine alone or in combination with M7824 (MSB0011359C). Recommended Phase 2 Dose, the dose of a drug or drug combination that was identified in a Phase 1 study (dose finding study) that was identified for continued study.

Source null

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primary · POSTED

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.

Source null

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primary · POSTED

CD3+ tumor infiltrating T cells post treatment compared with pre-treatment reported with a 95% confidence interval assessed by multiplex CD3+ tumor infiltrating lymphocytes assessed by multiplex immunofluorescence from the surgical/ biopsy tissue collected pre- and post-treatment. The percentage of participants with doubling of baseline CD3+ tumor infiltrating lymphocytes will be provided as well as the 95% confidence interval. The CD3 cells are assessed by multiplex immunofluorescence in the biopsies. Doubling is the desired outcome.

16/22 participants were evaluable because they received two treatments and had adequate biopsies.

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secondary · POSTED

Phase I: proportion of participants that are hospitalized because of adverse events attributed to disease progression. Adverse events were assessed by the Common Terminology Criteria for Adverse Events(CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. 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. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors(RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progression.

Source null

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secondary · POSTED

Phase II: Overall survival assessed using the Kaplan-Meier method, defined as the time from the date of first treatment to the date of death (any cause). Participants who receive two doses of PRGN-2009 and go on to receive standard definitive therapy will be evaluable for overall survival assessment.

Source null

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secondary · POSTED

Phase II: 3-year Relapse-free survival assessed using the Kaplan-Meier method, defined as the time from completion of standard of care definitive therapy to the date of disease recurrence or death (any cause) whichever occurs first. Participants who receive two doses of PRGN-2009 and go on to receive standard definitive therapy will be evaluable for overall survival assessment.

Source null

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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-cervical-cancer-keytruda-f5042205
nct id: NCT04432597
trial label: HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers
applicability: unclear
applicability note: Attached because the study's own record names PD-L1. 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: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-f5042205
nct id
NCT04432597
outcome key
om-0000
source section id
NCT04432597-om-0000
source outcome index
0
endpoint
Phase I: Recommended Phase II Dose of PRGN-2009
endpoint definition
Phase I: To determine the recommended phase II dose (RP2D) of PRGN-2009 Human Papillomavirus Vaccine (HPV) vaccine alone or in combination with M7824 (MSB0011359C). Recommended Phase 2 Dose, the dose of a drug or drug combination that was identified in a Phase 1 study (dose finding study) that was identified for continued study.
time origin
Date treatment consent signed to date off study, approximately 18 months
analysis role
primary
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-cervical-cancer-keytruda-f5042205
nct id
NCT04432597
outcome key
om-0001
source section id
NCT04432597-om-0001
source outcome index
1
endpoint
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
endpoint definition
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.
time origin
Date treatment consent signed to date off study, an average of 6 months
analysis role
primary
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-cervical-cancer-keytruda-f5042205
nct id
NCT04432597
outcome key
om-0002
source section id
NCT04432597-om-0002
source outcome index
2
endpoint
Phase II: Percentage of Participants That Had a 2-fold Increase of Cluster of Differentiation 3 (CD3+) Tumor Infiltrating T Cells in Biopsies Performed Post-treatment Compared to Pre-treatment
endpoint definition
CD3+ tumor infiltrating T cells post treatment compared with pre-treatment reported with a 95% confidence interval assessed by multiplex CD3+ tumor infiltrating lymphocytes assessed by multiplex immunofluorescence from the surgical/ biopsy tissue collected pre- and post-treatment. The percentage of participants with doubling of baseline CD3+ tumor infiltrating lymphocytes will be provided as well as the 95% confidence interval. The CD3 cells are assessed by multiplex immunofluorescence in the biopsies. Doubling is the desired outcome.
time origin
Pre-Treatment (Baseline) and anytime between Week 4-5 post treatment
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
16/22 participants were evaluable because they received two treatments and had adequate biopsies.
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-cervical-cancer-keytruda-f5042205
nct id
NCT04432597
outcome key
om-0003
source section id
NCT04432597-om-0003
source outcome index
3
endpoint
Phase I: Proportion of Participants That Are Hospitalized Because of Adverse Events Attributed to Disease Progression
endpoint definition
Phase I: proportion of participants that are hospitalized because of adverse events attributed to disease progression. Adverse events were assessed by the Common Terminology Criteria for Adverse Events(CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. 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. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors(RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progression.
time origin
Date treatment consent signed to date of progression, an average of 6 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-cervical-cancer-keytruda-f5042205
nct id
NCT04432597
outcome key
om-0004
source section id
NCT04432597-om-0004
source outcome index
4
endpoint
Phase II: 3-year Overall Survival for PRGN-2009 Alone
endpoint definition
Phase II: Overall survival assessed using the Kaplan-Meier method, defined as the time from the date of first treatment to the date of death (any cause). Participants who receive two doses of PRGN-2009 and go on to receive standard definitive therapy will be evaluable for overall survival assessment.
time origin
3 years
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-cervical-cancer-keytruda-f5042205
nct id
NCT04432597
outcome key
om-0005
source section id
NCT04432597-om-0005
source outcome index
5
endpoint
Phase II: 3 Year Relapse-free Survival for PRGN-2009 Alone
endpoint definition
Phase II: 3-year Relapse-free survival assessed using the Kaplan-Meier method, defined as the time from completion of standard of care definitive therapy to the date of disease recurrence or death (any cause) whichever occurs first. Participants who receive two doses of PRGN-2009 and go on to receive standard definitive therapy will be evaluable for overall survival assessment.
time origin
3 years
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

arms

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-f5042205
nct id
NCT04432597
outcome key
om-0000
arm key
OG000
arm label
All Participants in Phase I
regimen
All Participants in phase I who received at least one dose of Monotherapy Human Papillomavirus Vaccine (HPV) vaccine at 1x10\^11 Viral Particles (VP) and/or plus bintrafusp alfa 1200 mg.
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04432597-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-f5042205
nct id
NCT04432597
outcome key
om-0001
arm key
OG000
arm label
Phase I Cohort 1, Arm 1A, Dose Level 1
regimen
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).
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04432597-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-f5042205
nct id
NCT04432597
outcome key
om-0001
arm key
OG001
arm label
Phase I Cohort 1A, Arm 1A, Dose Level 2
regimen
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).
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04432597-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-f5042205
nct id
NCT04432597
outcome key
om-0001
arm key
OG002
arm label
Phase I Cohort 1, Arm 1B, Dose Level 2
regimen
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).
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04432597-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-f5042205
nct id
NCT04432597
outcome key
om-0002
arm key
OG000
arm label
Phase II Cohort 2, Arm 2A, Dose Level 2
regimen
Phase II in newly diagnosed, untreated, locoregional p16-positove oropharyngeal cancer (OPC) (cohort 2) and in newly diagnosed. Arm 2A: HPV vaccine at recommended phase 2 dose (RP2D) as determined at completion of Arm 1A. HPV vaccine at 5x10\^11 Viral Particles (VP).
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04432597-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-f5042205
nct id
NCT04432597
outcome key
om-0003
arm key
OG000
arm label
Phase I Cohort 1, Arm 1A, Dose Level 1
regimen
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).
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04432597-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-f5042205
nct id
NCT04432597
outcome key
om-0003
arm key
OG001
arm label
Phase I Cohort 1A, Arm 1A, Dose Level 2
regimen
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).
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04432597-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-f5042205
nct id
NCT04432597
outcome key
om-0003
arm key
OG002
arm label
Phase I Cohort 1, Arm 1B, Dose Level 2
regimen
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).
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04432597-om-0003#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-f5042205
nct id
NCT04432597
outcome key
om-0004
arm key
OG000
arm label
Phase II Cohort 2, Arm 2A, Dose Level 2
regimen
Phase II in newly diagnosed, untreated, locoregional p16-positove oropharyngeal cancer (OPC) (cohort 2) and in newly diagnosed. Arm 2A: HPV vaccine at recommended phase 2 dose (RP2D) as determined at completion of Arm 1A. HPV vaccine at 5x10\^11 Viral Particles (VP).
analyzed count
22
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04432597-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-f5042205
nct id
NCT04432597
outcome key
om-0005
arm key
OG000
arm label
Phase II Cohort 2, Arm 2A, Dose Level 2
regimen
Phase II in newly diagnosed, untreated, locoregional p16-positove oropharyngeal cancer (OPC) (cohort 2) and in newly diagnosed. Arm 2A: HPV vaccine at recommended phase 2 dose (RP2D) as determined at completion of Arm 1A. HPV vaccine at 5x10\^11 Viral Particles (VP).
analyzed count
22
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04432597-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-f5042205
nct id
NCT04432597
harm key
EG000
source section id
NCT04432597-ae
event group key
EG000
event group label
Phase I Cohort 1, Arm 1A, Dose Level 1
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
All-Cause Mortality is assessed from the time of first drug administration through the date of death (any cause) or up to 5 years. Adverse Events were monitored/assessed from the time of first drug administration through 28 days after the last drug administration, an average of 6 months.
event definition
Source null
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-cervical-cancer-keytruda-f5042205
nct id
NCT04432597
harm key
EG001
source section id
NCT04432597-ae
event group key
EG001
event group label
Phase I Cohort 1A, Arm 1A, Dose Level 2
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
All-Cause Mortality is assessed from the time of first drug administration through the date of death (any cause) or up to 5 years. Adverse Events were monitored/assessed from the time of first drug administration through 28 days after the last drug administration, an average of 6 months.
event definition
Source null
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-cervical-cancer-keytruda-f5042205
nct id
NCT04432597
harm key
EG002
source section id
NCT04432597-ae
event group key
EG002
event group label
Phase I Cohort 1, Arm 1B, Dose Level 2
serious affected
3
serious at risk
11
other affected
11
other at risk
11
frequency threshold
0
collection period
All-Cause Mortality is assessed from the time of first drug administration through the date of death (any cause) or up to 5 years. Adverse Events were monitored/assessed from the time of first drug administration through 28 days after the last drug administration, an average of 6 months.
event definition
Source null
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-cervical-cancer-keytruda-f5042205
nct id
NCT04432597
harm key
EG003
source section id
NCT04432597-ae
event group key
EG003
event group label
Phase II Cohort 2, Arm 2A, Dose Level 2
serious affected
0
serious at risk
22
other affected
22
other at risk
22
frequency threshold
0
collection period
All-Cause Mortality is assessed from the time of first drug administration through the date of death (any cause) or up to 5 years. Adverse Events were monitored/assessed from the time of first drug administration through 28 days after the last drug administration, an average of 6 months.
event definition
Source null
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