A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors

Draft scope assessment: unclear. Attached because the study's own record describes metastatic 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

DLT was defined as any of the following drug-related adverse events (AEs) occurring during the first cycle (21 days for IV dosing, 28 days for SC dosing) in Part 1: Grade 5 AE; Grade 4 neutropenia lasting \>5 days from initiation of granulocyte colony stimulating factor; Grade 4 thrombocytopenia with bleeding; Platelet transfusion requirement or a platelet count \<10,000/uL; Grade 4 non-hematologic AE; Grade 3 AE lasting \>7 days despite optimal supportive care; Grade 3 central nervous system AE regardless of duration; met criteria for drug induced liver injury. Severity of AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.

DLT analysis population included all enrolled participants who received at least 1 dose of study treatment and who did not have major treatment deviations during Cycle 1.

→

primary · POSTED

AE = any untoward medical occurrence in participant who received study treatment without regard to possibility of causal relationship. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Grades of severity were defined by CTCAE v4.03. Grades of severity were defined by CTCAE v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.

Analysis population included all enrolled participants who received at least 1 dose of study medication.

→

primary · POSTED

Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-related AEs and SAEs were determined by the investigator. Grades of severity were defined by CTCAE v4.03. Grades of severity were defined by CTCAE v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.

Analysis population included all enrolled participants who received at least 1 dose of study medication.

→

primary · POSTED

Following parameters were analyzed for laboratory examination: hematology (anemia, hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, white blood cell decreased); chemistries (increase of alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, blood bilirubin, CPK, creatinine, gamma-glutamyl transferase \[GGT\], lipase, and serum amylase); urinalysis (proteinuria); coagulation (activated partial thromboplastin time prolonged, international normalized ratio \[INR\] increased). Grades of severity were defined by CTCAE v4.03. Grade 0 = No Change from normal or reference range (this grade is not included in the CTCAE v4.03 document but may used in certain circumstances). Grade 1 = mild adverse event (AE). Grade 2 = moderate AE; Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.

Analysis population included all enrolled participants who received at least 1 dose of study medication.

→

primary · POSTED

ORR was defined as percentage of participants with confirmed objective response (OR) of complete response (CR) and partial response (PR) based on RECIST version 1.1. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \< 10 mm). All target lesions must be assessed. PR was defined as \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must be assessed.

Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.

→

primary · POSTED

ORR was defined as percentage of participants with objective response (OR) of complete response (CR) and partial response (PR) based on irRECIST. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \< 10 mm). All target lesions must be assessed. PR was defined as \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must be assessed.

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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

FACT · Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-urothelial-carcinoma-bavencio-1635adce
nct id: NCT02573259
qol key: qol-0000
source section id: NCT02573259-om-0000
source outcome index: 0
instrument: FACT
instrument basis: matched 'factor' in the study's own wording
scale title: Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1
measure definition: DLT was defined as any of the following drug-related adverse events (AEs) occurring during the first cycle (21 days for IV dosing, 28 days for SC dosing) in Part 1: Grade 5 AE; Grade 4 neutropenia lasting \>5 days from initiation of granulocyte colony stimulating factor; Grade 4 thrombocytopenia with bleeding; Platelet transfusion requirement or a platelet count \<10,000/uL; Grade 4 non-hematologic AE; Grade 3 AE lasting \>7 days despite optimal supportive care; Grade 3 central nervous system AE regardless of duration; met criteria for drug induced liver injury. Severity of AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.
time frame: Cycle 1 in Part 1 (21 days for IV administration of PF-06801591; 28 days for SC administration of PF-06801591)
analysis role: primary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: DLT analysis population included all enrolled participants who received at least 1 dose of study treatment and who did not have major treatment deviations during Cycle 1.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-urothelial-carcinoma-bavencio-1635adce
nct id: NCT02573259
trial label: A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors
applicability: unclear
applicability note: Attached because the study's own record describes metastatic 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: 10
qol Count: 1

outcomes

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
outcome key
om-0000
source section id
NCT02573259-om-0000
source outcome index
0
endpoint
Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1
endpoint definition
DLT was defined as any of the following drug-related adverse events (AEs) occurring during the first cycle (21 days for IV dosing, 28 days for SC dosing) in Part 1: Grade 5 AE; Grade 4 neutropenia lasting \>5 days from initiation of granulocyte colony stimulating factor; Grade 4 thrombocytopenia with bleeding; Platelet transfusion requirement or a platelet count \<10,000/uL; Grade 4 non-hematologic AE; Grade 3 AE lasting \>7 days despite optimal supportive care; Grade 3 central nervous system AE regardless of duration; met criteria for drug induced liver injury. Severity of AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.
time origin
Cycle 1 in Part 1 (21 days for IV administration of PF-06801591; 28 days for SC administration of PF-06801591)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
DLT analysis population included all enrolled participants who received at least 1 dose of study treatment and who did not have major treatment deviations during Cycle 1.
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-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
outcome key
om-0001
source section id
NCT02573259-om-0001
source outcome index
1
endpoint
Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2
endpoint definition
AE = any untoward medical occurrence in participant who received study treatment without regard to possibility of causal relationship. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Grades of severity were defined by CTCAE v4.03. Grades of severity were defined by CTCAE v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.
time origin
Baseline up to 28 days after last dose of study treatment (maximum of 1634 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Analysis population included all enrolled participants who received at least 1 dose of study medication.
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-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
outcome key
om-0002
source section id
NCT02573259-om-0002
source outcome index
2
endpoint
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2
endpoint definition
Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-related AEs and SAEs were determined by the investigator. Grades of severity were defined by CTCAE v4.03. Grades of severity were defined by CTCAE v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.
time origin
Baseline up to 28 days after last dose of study treatment (maximum of 1634 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Analysis population included all enrolled participants who received at least 1 dose of study medication.
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-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
outcome key
om-0003
source section id
NCT02573259-om-0003
source outcome index
3
endpoint
Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2
endpoint definition
Following parameters were analyzed for laboratory examination: hematology (anemia, hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, white blood cell decreased); chemistries (increase of alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, blood bilirubin, CPK, creatinine, gamma-glutamyl transferase \[GGT\], lipase, and serum amylase); urinalysis (proteinuria); coagulation (activated partial thromboplastin time prolonged, international normalized ratio \[INR\] increased). Grades of severity were defined by CTCAE v4.03. Grade 0 = No Change from normal or reference range (this grade is not included in the CTCAE v4.03 document but may used in certain circumstances). Grade 1 = mild adverse event (AE). Grade 2 = moderate AE; Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.
time origin
Baseline up to 28 days after last dose of study treatment (maximum of 1634 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Analysis population included all enrolled participants who received at least 1 dose of study medication.
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-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
outcome key
om-0004
source section id
NCT02573259-om-0004
source outcome index
4
endpoint
Objective Response Rate (ORR) Based on RECIST Version 1.1 - Part 2
endpoint definition
ORR was defined as percentage of participants with confirmed objective response (OR) of complete response (CR) and partial response (PR) based on RECIST version 1.1. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \< 10 mm). All target lesions must be assessed. PR was defined as \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must be assessed.
time origin
Baseline up to end of treatment in Part 2 (maximum of 851 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.
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-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
outcome key
om-0005
source section id
NCT02573259-om-0005
source outcome index
5
endpoint
Objective Response Rate (ORR) Based on Immune Related RECIST (irRECIST) - Part 2
endpoint definition
ORR was defined as percentage of participants with objective response (OR) of complete response (CR) and partial response (PR) based on irRECIST. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \< 10 mm). All target lesions must be assessed. PR was defined as \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must be assessed.
time origin
Baseline up to end of treatment in Part 2 (maximum of 851 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.
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-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
outcome key
om-0000
arm key
OG000
arm label
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
regimen
Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02573259-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
outcome key
om-0000
arm key
OG001
arm label
Part 1: PF-06801591 1 mg/kg (IV)
regimen
Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02573259-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
outcome key
om-0000
arm key
OG002
arm label
Part 1: PF-06801591 3 mg/kg (IV)
regimen
Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02573259-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
outcome key
om-0000
arm key
OG003
arm label
Part 1: PF-06801591 10 mg/kg (IV)
regimen
Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02573259-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
outcome key
om-0000
arm key
OG004
arm label
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
regimen
Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02573259-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
outcome key
om-0001
arm key
OG000
arm label
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
regimen
Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02573259-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
outcome key
om-0001
arm key
OG001
arm label
Part 1: PF-06801591 1 mg/kg (IV)
regimen
Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02573259-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
outcome key
om-0001
arm key
OG002
arm label
Part 1: PF-06801591 3 mg/kg (IV)
regimen
Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02573259-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
outcome key
om-0001
arm key
OG003
arm label
Part 1: PF-06801591 10 mg/kg (IV)
regimen
Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02573259-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
outcome key
om-0001
arm key
OG004
arm label
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
regimen
Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02573259-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
outcome key
om-0001
arm key
OG005
arm label
Part 2: PF-06801591 300 mg (SC) for NSCLC
regimen
Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)
analyzed count
68
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02573259-om-0001#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
outcome key
om-0001
arm key
OG006
arm label
Part 2: PF-06801591 300 mg (SC) for UC
regimen
Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
analyzed count
38
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02573259-om-0001#groups/OG006

harms

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
harm key
EG000
source section id
NCT02573259-ae
event group key
EG000
event group label
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
serious affected
1
serious at risk
2
other affected
2
other at risk
2
frequency threshold
5
collection period
Baseline up to 28 days after last dose of study drug (up to a maximum of 237 weeks).
event definition
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
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-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
harm key
EG001
source section id
NCT02573259-ae
event group key
EG001
event group label
Part 1: PF-06801591 1 mg/kg (IV)
serious affected
3
serious at risk
8
other affected
7
other at risk
8
frequency threshold
5
collection period
Baseline up to 28 days after last dose of study drug (up to a maximum of 237 weeks).
event definition
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
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-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
harm key
EG002
source section id
NCT02573259-ae
event group key
EG002
event group label
Part 1: PF-06801591 3 mg/kg (IV)
serious affected
3
serious at risk
8
other affected
8
other at risk
8
frequency threshold
5
collection period
Baseline up to 28 days after last dose of study drug (up to a maximum of 237 weeks).
event definition
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
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-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
harm key
EG003
source section id
NCT02573259-ae
event group key
EG003
event group label
Part 1: PF-06801591 10 mg/kg (IV)
serious affected
3
serious at risk
7
other affected
7
other at risk
7
frequency threshold
5
collection period
Baseline up to 28 days after last dose of study drug (up to a maximum of 237 weeks).
event definition
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
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-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
harm key
EG004
source section id
NCT02573259-ae
event group key
EG004
event group label
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
serious affected
3
serious at risk
15
other affected
15
other at risk
15
frequency threshold
5
collection period
Baseline up to 28 days after last dose of study drug (up to a maximum of 237 weeks).
event definition
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
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-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
harm key
EG005
source section id
NCT02573259-ae
event group key
EG005
event group label
Part 1: PF-06801591 IV Total
serious affected
10
serious at risk
25
other affected
24
other at risk
25
frequency threshold
5
collection period
Baseline up to 28 days after last dose of study drug (up to a maximum of 237 weeks).
event definition
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
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-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
harm key
EG006
source section id
NCT02573259-ae
event group key
EG006
event group label
Part 1: PF-06801591 IV and SC Total
serious affected
13
serious at risk
40
other affected
39
other at risk
40
frequency threshold
5
collection period
Baseline up to 28 days after last dose of study drug (up to a maximum of 237 weeks).
event definition
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
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-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
harm key
EG007
source section id
NCT02573259-ae
event group key
EG007
event group label
Part 2: PF-06801591 300 mg (SC) for NSCLC
serious affected
18
serious at risk
68
other affected
59
other at risk
68
frequency threshold
5
collection period
Baseline up to 28 days after last dose of study drug (up to a maximum of 237 weeks).
event definition
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
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-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
harm key
EG008
source section id
NCT02573259-ae
event group key
EG008
event group label
Part 2: PF-06801591 300 mg (SC) for UC
serious affected
13
serious at risk
38
other affected
33
other at risk
38
frequency threshold
5
collection period
Baseline up to 28 days after last dose of study drug (up to a maximum of 237 weeks).
event definition
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
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-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
harm key
EG009
source section id
NCT02573259-ae
event group key
EG009
event group label
Part 2: PF-06801591 NSCLC and UC Total
serious affected
31
serious at risk
106
other affected
92
other at risk
106
frequency threshold
5
collection period
Baseline up to 28 days after last dose of study drug (up to a maximum of 237 weeks).
event definition
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
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

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-bavencio-1635adce
nct id
NCT02573259
qol key
qol-0000
source section id
NCT02573259-om-0000
source outcome index
0
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1
measure definition
DLT was defined as any of the following drug-related adverse events (AEs) occurring during the first cycle (21 days for IV dosing, 28 days for SC dosing) in Part 1: Grade 5 AE; Grade 4 neutropenia lasting \>5 days from initiation of granulocyte colony stimulating factor; Grade 4 thrombocytopenia with bleeding; Platelet transfusion requirement or a platelet count \<10,000/uL; Grade 4 non-hematologic AE; Grade 3 AE lasting \>7 days despite optimal supportive care; Grade 3 central nervous system AE regardless of duration; met criteria for drug induced liver injury. Severity of AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.
time frame
Cycle 1 in Part 1 (21 days for IV administration of PF-06801591; 28 days for SC administration of PF-06801591)
analysis role
primary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
DLT analysis population included all enrolled participants who received at least 1 dose of study treatment and who did not have major treatment deviations during Cycle 1.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice