NCT03260023 · STUDY IN CONTEXT

Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

Dose limiting toxicities (DLTs) includes the following: * Grade ≥ 3 drug related adverse event (AEs). However, fatigue, nausea/vomiting adequately treated with anti-emetics, endocrinopathies adequately controlled with one physiologic hormone replacement, skin toxicity and single laboratory values out of normal range without any clinical correlate, asymptomatic grade ≥3 lipase or amylase elevation, tumor flare defined as local pain, irritation, or rash localized at sites of known or suspected tumor or a transient Grade 3 infusion adverse event are excluded. * Liver function test abnormality: * AST or ALT \> 5 x ULN * Total bilirubin \> 3 x ULN * Concurrent AST or ALT \> 3 x ULN and total bilirubin \> 2 x ULN * Drug related AE requiring treatment interruption for more than 2 weeks

Phase Ib : All participants included and who received any amount of study treatment were included in the SAF. Any participant who was assigned a participant number, but did not receive any study treatment was not included in the SAF. Phase II part 1 and Phase II part 2: the outcome measure safety and tolerability has not been defined as primary endpoint. Therefore Phase II part 1 and Phase II part 2 are not included in the analysis population for safety and tolerability as primary endpoint.

→

primary · POSTED

Percentage of participants whose best overall response is either a Complete Response or a Partial Response according to Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria over the the total number of evaluable participants. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.

Phase II part 1 (Evaluable per protocol): Participants dosed with both IMPs and with at least baseline and post-baseline evaluable CT-scan at week 6 according to RECIST 1.1 and no major inc/exc, dosing or protocol violation, except if participant progressed or died due to disease. Phase Ib and phase II part 2: the outcome measure ORR has not been defined as primary endpoint. Therefore Phase Ib and phase II part 2 are not included in the analysis population for ORR as primary endpoint.

→

primary · POSTED

PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death due to any cause, whichever occurs first. If a participant has not had a PFS event at the cut-off date for analysis or at the date when a further antineoplastic therapy (other than those planned as study treatment in the protocol) is started, PFS will be censored at the date of last evaluable tumor assessment before the cut-off or start of further antineoplastic therapy.

Phase II part 2, Cohort A: All randomized participants who were adminstered at least one dose of IMP(s) according to the treatment allocated at randomization. (FAS) For Phase Ib, Phase II part 1 and Phase II part 2 Cohort B : the outcome measure PFS has not been defined as primary endpoint Therefore Phase Ib, Phase II part 1 and Phase II part 2 Cohort B are not included in the analysis population for PFS as primary endpoint.

→

primary · POSTED

PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death due to any cause, whichever occurs first. If a participant has not had a PFS event at the cut-off date for analysis or at the date when a further antineoplastic therapy (other than those planned as study treatment in the protocol) is started, PFS will be censored at the date of last evaluable tumor assessment before the cut-off or start of further antineoplastic therapy.

Phase II part 2 Cohort A: All randomized participants who were adminstered at least one dose of IMP(s) according to the treatment allocated at randomization. (FAS) For Phase Ib, Phase II part 1 and Phase II part 2 Cohort B : the outcome measure PFS has not been defined as primary endpoint. Therefore Phase Ib, Phase II part 1 and Phase II part 2 Cohort B are not included in the analysis population for PFS as primary endpoint.

→

secondary · POSTED

Percentage of participants whose best overall response is either a Complete Response or a Partial Response according to Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria over the the total number of evaluable participants. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.

For Phase Ib / Phase II part 2 Cohort A: All participants who received at least one dose of IMP(s) according to treatment allocation. Phase II part 1 and phase II part 2 Cohort B: the outcome measure ORR has not been defined as secondary endpoint. Therefore Phase II part 1 and phase II part 2 Cohort B are not included in the analysis population for ORR as secondary endpoint.

→

secondary · POSTED

PFS is defined as the time from the date of first study treatment administration (Phase Ib, Phase II Part1) to the date of first documented tumor progression or death due to any cause, whichever occurs first. If a participant has not had a PFS event at the cut-off date for analysis or at the date when a further antineoplastic therapy (other than those planned as study treatment in the protocol) is started, PFS will be censored at the date of last evaluable tumor assessment before the cut-off or start of further antineoplastic therapy.

For Phase Ib: All participants included and who received any amount of study treatment. For phase II part 1: Evaluable participants population (EPP) Phase II part 2, cohort A and cohort B : the outcome measure PFS has not been defined as secondary endpoint. Therefore Phase II part 2, cohort A and cohort B are not included in the analysis population for PFS as secondary endpoint.

→

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-anal-cancer
nct id: NCT03260023
trial label: Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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: 7
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-anal-cancer
nct id
NCT03260023
outcome key
om-0000
source section id
NCT03260023-om-0000
source outcome index
0
endpoint
Phase Ib: To Evaluate the Safety and Tolerability of the Combination of TG4001 Plus Avelumab in Participants With Recurrent or Metastatic HPV-16 Positive Advanced Malignancies
endpoint definition
Dose limiting toxicities (DLTs) includes the following: * Grade ≥ 3 drug related adverse event (AEs). However, fatigue, nausea/vomiting adequately treated with anti-emetics, endocrinopathies adequately controlled with one physiologic hormone replacement, skin toxicity and single laboratory values out of normal range without any clinical correlate, asymptomatic grade ≥3 lipase or amylase elevation, tumor flare defined as local pain, irritation, or rash localized at sites of known or suspected tumor or a transient Grade 3 infusion adverse event are excluded. * Liver function test abnormality: * AST or ALT \> 5 x ULN * Total bilirubin \> 3 x ULN * Concurrent AST or ALT \> 3 x ULN and total bilirubin \> 2 x ULN * Drug related AE requiring treatment interruption for more than 2 weeks
time origin
From Day 1 to Day 28
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Phase Ib : All participants included and who received any amount of study treatment were included in the SAF. Any participant who was assigned a participant number, but did not receive any study treatment was not included in the SAF. Phase II part 1 and Phase II part 2: the outcome measure safety and tolerability has not been defined as primary endpoint. Therefore Phase II part 1 and Phase II part 2 are not included in the analysis population for safety and tolerability as primary endpoint.
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-anal-cancer
nct id
NCT03260023
outcome key
om-0001
source section id
NCT03260023-om-0001
source outcome index
1
endpoint
Phase II Part 1: Overall Response Rate (ORR) by RECIST 1.1
endpoint definition
Percentage of participants whose best overall response is either a Complete Response or a Partial Response according to Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria over the the total number of evaluable participants. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.
time origin
From treatment start, every 6 weeks for the first 9 months, then every 12 weeks up to 2 years.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Phase II part 1 (Evaluable per protocol): Participants dosed with both IMPs and with at least baseline and post-baseline evaluable CT-scan at week 6 according to RECIST 1.1 and no major inc/exc, dosing or protocol violation, except if participant progressed or died due to disease. Phase Ib and phase II part 2: the outcome measure ORR has not been defined as primary endpoint. Therefore Phase Ib and phase II part 2 are not included in the analysis population for ORR as primary endpoint.
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-anal-cancer
nct id
NCT03260023
outcome key
om-0002
source section id
NCT03260023-om-0002
source outcome index
2
endpoint
Phase II Part 2 Cohort A: Progression Free Survival (PFS) by RECIST 1.1
endpoint definition
PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death due to any cause, whichever occurs first. If a participant has not had a PFS event at the cut-off date for analysis or at the date when a further antineoplastic therapy (other than those planned as study treatment in the protocol) is started, PFS will be censored at the date of last evaluable tumor assessment before the cut-off or start of further antineoplastic therapy.
time origin
From randomization: Every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 1 year.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Phase II part 2, Cohort A: All randomized participants who were adminstered at least one dose of IMP(s) according to the treatment allocated at randomization. (FAS) For Phase Ib, Phase II part 1 and Phase II part 2 Cohort B : the outcome measure PFS has not been defined as primary endpoint Therefore Phase Ib, Phase II part 1 and Phase II part 2 Cohort B are not included in the analysis population for PFS as primary endpoint.
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-anal-cancer
nct id
NCT03260023
outcome key
om-0003
source section id
NCT03260023-om-0003
source outcome index
3
endpoint
Progression Free Survival (PFS) Phase II Part 2 Cohort A by Stratification
endpoint definition
PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death due to any cause, whichever occurs first. If a participant has not had a PFS event at the cut-off date for analysis or at the date when a further antineoplastic therapy (other than those planned as study treatment in the protocol) is started, PFS will be censored at the date of last evaluable tumor assessment before the cut-off or start of further antineoplastic therapy.
time origin
From randomization: Every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 1 year.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Phase II part 2 Cohort A: All randomized participants who were adminstered at least one dose of IMP(s) according to the treatment allocated at randomization. (FAS) For Phase Ib, Phase II part 1 and Phase II part 2 Cohort B : the outcome measure PFS has not been defined as primary endpoint. Therefore Phase Ib, Phase II part 1 and Phase II part 2 Cohort B are not included in the analysis population for PFS as primary endpoint.
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-anal-cancer
nct id
NCT03260023
outcome key
om-0004
source section id
NCT03260023-om-0004
source outcome index
4
endpoint
Overall Response Rate (ORR) by Using RECIST 1.1 : Phase Ib, Phase II Part 2 Cohort A
endpoint definition
Percentage of participants whose best overall response is either a Complete Response or a Partial Response according to Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria over the the total number of evaluable participants. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.
time origin
From treatment start (phase Ib) / randomization (phase II part 2) : Every 6 weeks for the first 9 months, then every 12 weeks up to 2 years.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
For Phase Ib / Phase II part 2 Cohort A: All participants who received at least one dose of IMP(s) according to treatment allocation. Phase II part 1 and phase II part 2 Cohort B: the outcome measure ORR has not been defined as secondary endpoint. Therefore Phase II part 1 and phase II part 2 Cohort B are not included in the analysis population for ORR as secondary endpoint.
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-anal-cancer
nct id
NCT03260023
outcome key
om-0005
source section id
NCT03260023-om-0005
source outcome index
5
endpoint
Progression Free Survival (PFS) (Phase Ib, Phase II Part 1)
endpoint definition
PFS is defined as the time from the date of first study treatment administration (Phase Ib, Phase II Part1) to the date of first documented tumor progression or death due to any cause, whichever occurs first. If a participant has not had a PFS event at the cut-off date for analysis or at the date when a further antineoplastic therapy (other than those planned as study treatment in the protocol) is started, PFS will be censored at the date of last evaluable tumor assessment before the cut-off or start of further antineoplastic therapy.
time origin
From treatment start (phase Ib, phase II part 1): Every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 1 year.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
For Phase Ib: All participants included and who received any amount of study treatment. For phase II part 1: Evaluable participants population (EPP) Phase II part 2, cohort A and cohort B : the outcome measure PFS has not been defined as secondary endpoint. Therefore Phase II part 2, cohort A and cohort B are not included in the analysis population for PFS as secondary endpoint.
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-anal-cancer
nct id
NCT03260023
outcome key
om-0000
arm key
OG000
arm label
Phase I - TG4001 5x10e6 Pfu + Avelumab
regimen
Participants received 5x10e6 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03260023-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-anal-cancer
nct id
NCT03260023
outcome key
om-0000
arm key
OG001
arm label
Phase I - TG4001 5x10e7 Pfu + Avelumab
regimen
Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03260023-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-anal-cancer
nct id
NCT03260023
outcome key
om-0001
arm key
OG000
arm label
Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab
regimen
Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03260023-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-anal-cancer
nct id
NCT03260023
outcome key
om-0002
arm key
OG000
arm label
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab
regimen
Participants received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
analyzed count
46
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03260023-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-anal-cancer
nct id
NCT03260023
outcome key
om-0002
arm key
OG001
arm label
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab
regimen
Participants without liver metastasis received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
analyzed count
44
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03260023-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-anal-cancer
nct id
NCT03260023
outcome key
om-0003
arm key
OG000
arm label
Phase II Part 2 - Cohort A - Cervix Cancer - TG4001 5x10e7 Pfu + Avelumab
regimen
Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03260023-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-anal-cancer
nct id
NCT03260023
outcome key
om-0003
arm key
OG001
arm label
Phase II Part 2 - Cohort A - Cervix Cancer - Avelumab
regimen
Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03260023-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-anal-cancer
nct id
NCT03260023
outcome key
om-0003
arm key
OG002
arm label
Phase II Part 2 - Cohort A - Anal Cancer - TG4001 5x10e7 Pfu + Avelumab
regimen
Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03260023-om-0003#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-anal-cancer
nct id
NCT03260023
outcome key
om-0003
arm key
OG003
arm label
Phase II Part 2 - Cohort A - Anal Cancer - Avelumab
regimen
Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03260023-om-0003#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-anal-cancer
nct id
NCT03260023
outcome key
om-0003
arm key
OG004
arm label
Phase II Part 2 - Cohort A - Genital Cancer - TG4001 5x10e7 Pfu + Avelumab
regimen
Participants without liver metastases received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03260023-om-0003#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-anal-cancer
nct id
NCT03260023
outcome key
om-0003
arm key
OG005
arm label
Phase II Part 2 - Cohort A - Genital Cancer - Avelumab
regimen
Participants without liver metastases received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03260023-om-0003#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-anal-cancer
nct id
NCT03260023
outcome key
om-0004
arm key
OG000
arm label
Phase I - TG4001 5x10e6 Pfu + Avelumab
regimen
Participants received 5x10e6 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03260023-om-0004#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-anal-cancer
nct id
NCT03260023
harm key
EG000
source section id
NCT03260023-ae
event group key
EG000
event group label
Phase I - TG4001 5x10e6 Pfu + Avelumab
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 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-anal-cancer
nct id
NCT03260023
harm key
EG001
source section id
NCT03260023-ae
event group key
EG001
event group label
Phase I - TG4001 5x10e7 Pfu + Avelumab
serious affected
4
serious at risk
6
other affected
6
other at risk
6
frequency threshold
0
collection period
All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 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-anal-cancer
nct id
NCT03260023
harm key
EG002
source section id
NCT03260023-ae
event group key
EG002
event group label
Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab
serious affected
18
serious at risk
34
other affected
34
other at risk
34
frequency threshold
0
collection period
All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 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-anal-cancer
nct id
NCT03260023
harm key
EG003
source section id
NCT03260023-ae
event group key
EG003
event group label
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab
serious affected
16
serious at risk
46
other affected
46
other at risk
46
frequency threshold
0
collection period
All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 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-anal-cancer
nct id
NCT03260023
harm key
EG004
source section id
NCT03260023-ae
event group key
EG004
event group label
Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab
serious affected
18
serious at risk
44
other affected
43
other at risk
44
frequency threshold
0
collection period
All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 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-anal-cancer
nct id
NCT03260023
harm key
EG005
source section id
NCT03260023-ae
event group key
EG005
event group label
Phase II Part 2 - Cohort B - Participants With Liver Metastases - TG4001 5x10e7 PFU + Avelumab
serious affected
2
serious at risk
5
other affected
5
other at risk
5
frequency threshold
0
collection period
All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 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-anal-cancer
nct id
NCT03260023
harm key
EG006
source section id
NCT03260023-ae
event group key
EG006
event group label
Phase II Part 2 - Cohort B - Participants With Liver Metastases - Avelumab
serious affected
0
serious at risk
4
other affected
4
other at risk
4
frequency threshold
0
collection period
All-cause mortality was assessed for up to 4.5 years. All non serious AEs not treatment related were reported from start of study treatment up to 30 days after last administration of study treatments through study completion for an average of 7 months. All treatment related non serious AEs and all SAEs were reported from start of study treatment up to 90 days after last administration of study treamtents through study completion for an average of 8.5 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