Trial · NCT02573259
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
NCT02573259, Phase 1, Completed, Pfizer; results first posted 2021-12-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT02573259. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02573259
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT02573259
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 147 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Part 1, MELANOMA, SCCHN, OVCA, SARCOMA, OTHER SOLID TUMORS, Part 1 and 2, NSCLC, UROTHELIAL CARCINOMA
- Interventions
- PF-06801591, PF-06801591
- First posted
- 2015-10-09
- Last updated
- 2021-12-13
- Other registries' IDs
- eudract:2016-003314-27
- Results first posted
- 2021-12-13
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1 | Cycle 1 in Part 1 (21 days for IV administration of PF-06801591; 28 days for SC administration of PF-06801591) | 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. |
| Primary | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Baseline up to 28 days after last dose of study treatment (maximum of 1634 days) | 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. |
| Primary | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Baseline up to 28 days after last dose of study treatment (maximum of 1634 days) | 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. |
| Primary | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | Baseline up to 28 days after last dose of study treatment (maximum of 1634 days) | 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. |
| Primary | Objective Response Rate (ORR) Based on RECIST Version 1.1 - Part 2 | Baseline up to end of treatment in Part 2 (maximum of 851 days) | 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. |
| Primary | Objective Response Rate (ORR) Based on Immune Related RECIST (irRECIST) - Part 2 | Baseline up to end of treatment in Part 2 (maximum of 851 days) | 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. |
| Secondary | Maximum Plasma Concentration (Cmax) of PF-06801591 - Part 1 | Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1 | Cmax was the maximum concentration after dose administration observed directly from the data. |
| Secondary | AUClast of PF-06801591 in Part 1. | Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1 in Part 1 | Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Prior to the Next Dose (AUClast) of PF-06801591 - Part 1 |
| Secondary | Clearance (CL) of PF-06801591 - Part 1 | Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1 | CL for IV dosing. CL was calculated by dose / AUCtau for Cycles 1 and 4 IV dosing. AUCtau was defined as area under the serum concentration time profile from time zero to time tau, the dosing interval, where tau = 504 hours for every 3 weeks (Q3W) IV dosing reporting arm. |
| Secondary | Volume of Distribution at Steady State (Vss) of PF-06801591 - Part 1 | Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1 | Steady state volume of distribution of PF-0680159 for IV dosing. Vss was calculated by CL\*MRT. CL was the clearance for IV dosing. MRT was the mean residence time calculated for a single IV dose as AUMCinf/AUCinf - (DOF/2). AUMCinf was the area under the moment curve from time 0 extrapolated to infinity. DOF was the duration of infusion. AUCinf was the area under the serum concentration time profile from time 0 extrapolated to infinity. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1 | Cycle 1 in Part 1 (21 days for IV administration of PF-06801591; 28 days for SC administration of PF-06801591) | 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. | Percentage of Participants | NUMBER |
| PRIMARY | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Baseline up to 28 days after last dose of study treatment (maximum of 1634 days) | Analysis population included all enrolled participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Baseline up to 28 days after last dose of study treatment (maximum of 1634 days) | Analysis population included all enrolled participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | Baseline up to 28 days after last dose of study treatment (maximum of 1634 days) | Analysis population included all enrolled participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Objective Response Rate (ORR) Based on RECIST Version 1.1 - Part 2 | Baseline up to end of treatment in Part 2 (maximum of 851 days) | 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. | Percentage | NUMBER |
| PRIMARY | Objective Response Rate (ORR) Based on Immune Related RECIST (irRECIST) - Part 2 | Baseline up to end of treatment in Part 2 (maximum of 851 days) | 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. | Percentage of Participants | NUMBER |
| SECONDARY | Maximum Plasma Concentration (Cmax) of PF-06801591 - Part 1 | Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1 | Analysis population included all enrolled participants treated who were evaluable for this outcome measure. | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | AUClast of PF-06801591 in Part 1. | Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1 in Part 1 | Analysis population included all enrolled participants treated who were evaluable for this outcome measure. | ug*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | Clearance (CL) of PF-06801591 - Part 1 | Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1 | Analysis population included all enrolled participants treated who were evaluable for this outcome measure. | L/hr | GEOMETRIC_MEAN |
| SECONDARY | Volume of Distribution at Steady State (Vss) of PF-06801591 - Part 1 | Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1 | The PK parameter analysis population was defined as all enrolled participants in Part 1 who received study drug following IV administration and had sufficient information to estimate at least 1 of the pharmacokinetic (PK) parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants who had reportable parameter values of Vss. | L | GEOMETRIC_MEAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group1,266
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1 | Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 0 | Percentage of Participants | ||
| Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1 | Part 1: PF-06801591 1 mg/kg (IV) | 0 | Percentage of Participants | ||
| Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1 | Part 1: PF-06801591 3 mg/kg (IV) | 0 | Percentage of Participants | ||
| Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1 | Part 1: PF-06801591 10 mg/kg (IV) | 0 | Percentage of Participants | ||
| Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1 | Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 0 | Percentage of Participants | ||
| Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Participants with AEs | 2 | Participants | |
| Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Part 1: PF-06801591 1 mg/kg (IV) | Participants with AEs | 7 | Participants | |
| Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Part 1: PF-06801591 3 mg/kg (IV) | Participants with AEs | 8 | Participants | |
| Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Part 1: PF-06801591 10 mg/kg (IV) | Participants with AEs | 7 | Participants | |
| Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Participants with AEs | 15 | Participants |
1 to 10 of 1,266Source ClinicalTrials.gov
See all 1,266 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 2 | |
| Overall Study | STARTED | Part 1: PF-06801591 1 mg/kg (IV) | 8 | |
| Overall Study | STARTED | Part 1: PF-06801591 3 mg/kg (IV) | 8 | |
| Overall Study | STARTED | Part 1: PF-06801591 10 mg/kg (IV) | 7 | |
| Overall Study | STARTED | Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 15 | |
| Overall Study | STARTED | Part 2: PF-06801591 300 mg (SC) for NSCLC | 68 | |
| Overall Study | STARTED | Part 2: PF-06801591 300 mg (SC) for UC | 39 | |
| Overall Study | Treated | Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 2 | |
| Overall Study | Treated | Part 1: PF-06801591 1 mg/kg (IV) | 8 | |
| Overall Study | Treated | Part 1: PF-06801591 3 mg/kg (IV) | 8 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events2,520
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Atrial fibrillation | Cardiac disorders | Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 0 | 2 | |
| other | Atrial fibrillation | Cardiac disorders | Part 1: PF-06801591 1 mg/kg (IV) | 1 | 8 | |
| other | Atrial fibrillation | Cardiac disorders | Part 1: PF-06801591 3 mg/kg (IV) | 0 | 8 | |
| other | Atrial fibrillation | Cardiac disorders | Part 1: PF-06801591 10 mg/kg (IV) | 0 | 7 | |
| other | Atrial fibrillation | Cardiac disorders | Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 0 | 15 | |
| other | Atrial fibrillation | Cardiac disorders | Part 1: PF-06801591 IV Total | 1 | 25 | |
| other | Atrial fibrillation | Cardiac disorders | Part 1: PF-06801591 IV and SC Total | 1 | 40 | |
| other | Atrial fibrillation | Cardiac disorders | Part 2: PF-06801591 300 mg (SC) for NSCLC | 3 | 68 | |
| other | Atrial fibrillation | Cardiac disorders | Part 2: PF-06801591 300 mg (SC) for UC | 0 | 38 | |
| other | Atrial fibrillation | Cardiac disorders | Part 2: PF-06801591 NSCLC and UC Total | 3 | 106 |
1 to 10 of 2,520Source ClinicalTrials.gov
See all 2,520 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 1 | 2 |
| Total, all-cause mortality | Part 1: PF-06801591 1 mg/kg (IV) | 6 | 8 |
| Total, all-cause mortality | Part 1: PF-06801591 3 mg/kg (IV) | 5 | 8 |
| Total, all-cause mortality | Part 1: PF-06801591 10 mg/kg (IV) | 6 | 7 |
| Total, all-cause mortality | Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 10 | 15 |
| Total, all-cause mortality | Part 1: PF-06801591 IV Total | 18 | 25 |
| Total, all-cause mortality | Part 1: PF-06801591 IV and SC Total | 28 | 40 |
| Total, all-cause mortality | Part 2: PF-06801591 300 mg (SC) for NSCLC | 33 | 68 |
| Total, all-cause mortality | Part 2: PF-06801591 300 mg (SC) for UC | 21 | 38 |
| Total, all-cause mortality | Part 2: PF-06801591 NSCLC and UC Total | 54 | 106 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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