Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| KEYNOTE-0036 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a safety, pharmacokinetic and pharmacodynamic study designed to estimate the maximum tolerated dose (MTD), and determine the Recommended Phase 2 Dose (RP2D) of PF-05082566, a 4-1BB agonist monoclonal antibody (mAb), in combination with MK-3475, a PD-1 inhibitor in patients with solid tumors.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-05082566 +MK-3475 | Experimental | PF-05082566 +MK-3475 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05082566 | Drug | Starting dose of 0.45 mg/kg q3wks IV, dose escalation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-Limiting Toxicities (DLT) of PF-05082566 in Combination With MK-3475 | Severity of adverse events (AEs) was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the purpose of dose escalation, any of the following AEs occurring during the DLT observation period that were attributable to one or both study drugs were classified as DLTs. 1) Hematologic: Grade 4 neutropenia; Febrile neutropenia, defined as absolute neutrophil count (ANC) <1000/mm3 with a single temperature of >38.3C(101F) or a sustained temperature of 38C (100.4F) for more than 1 hour; Grade>=3 neutropenic infection; Grade>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia. 2) Non hematologic: Grade>=3 toxicities (non-laboratory); Grade>=3 nausea, vomiting or diarrhea despite maximal medical therapy; Grade 4 aspartate aminotransferase (AST) and alanine aminotransferase (ALT). 3) Other (non-AST/ALT) non-hematologic Grade>=3 laboratory value. 4) Inability to complete 2 infusions of MK-3475 and PF-05082566 during the DLT observation period. | First 2 cycles of treatment up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by National Cancer Institute (NCI) CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
CNS primary malignancies, active seizure disorder or spinal cord compression, or carcinomatous meningitis.
History of any of the following toxicities associated with a prior immunotherapy:
Any of the following within the 12 months prior to registration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism.
History of or known presence of extensive, disseminated/bilateral or Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, or pulmonary fibrosis, but not including a history of prior radiation pneumonitis. Patients with clinically significant lung disease requiring oxygen therapy (eg, COPD).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Administration Office | Los Angeles | California | 90095 | United States | ||
| Ronald Reagan UCLA Medical Center, Drug Information Center |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg every 3 weeks (q3wks) on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 8, 2014 | Feb 23, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| MK-3475 |
| Drug |
2 mg/kg q3wks, IV |
|
|
| Baseline up to 90 days after the last dose of study drug, approximately 27 months |
| Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE. | Baseline up to 90 days after the last dose of study drug, approximately 27 months |
| Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE. | Baseline up to 90 days after the last dose of study drug, approximately 27 months |
| Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE. | Baseline up to 90 days after the last dose of study drug, approximately 27 months |
| Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | The hematology laboratory test included: absolute neutrophil count, hemoglobin, platelet count, white blood cell with differential, coagulation panel, urinalysis and pregnancy test. Laboratory results were categorical summarized according to the NCI-CTCAE criteria version 4.03. The total number of participants with hematology laboratory test was assessed. | Baseline up to 28 days after the last dose of study drug, approximately 25 months |
| Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | The chemical laboratory test included: sodium, potassium, total calcium, creatinine, albumin, alanine aminotransferase, alanine aminotransferase, glucose, phosphorus, magnesium, total bilirubin, blood urea nitrogen, alkaline phosphatase, lactate dehydrogenase, immunoglobulin G, total protein, uric acid, thyroid function assessments, hepatitis B and C tests. Laboratory results were categorical summarized according to the NCI-CTCAE criteria version 4.03. The total number of participants with chemistry laboratory test was assessed. | Baseline up to 28 days after the last dose of study drug, approximately 25 months |
| Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern | Vital sign summaries included all vital sign assessments from the on-treatment period. All vital sign parameters including blood pressure (BP) and weight were summarized using actual values and changes from baseline for each visit over time. The changes computed were the differences from baseline. The participants meeting criteria of potential clinical concern were judged by investigator. | Baseline up to 28 days after the last dose of study drug, approximately 25 months |
| Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | The ECOG shift from baseline to highest score during the on-treatment period was summarized by treatment group.ECOG Performance Status included 0, 1, 2, 3, and 4 grades. Grade 1 was Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature. Grade 2 was Ambulatory and capable of all self care but unable to carry out any work activities.Up and about more than 50% of waking hours. Grade 3 was capable of only limited self care, confined to bed or chair more than 50% of waking hours. Grade 4 was completely disabled. Cannot carry on any self care. Totally confined to bed or chair. | Baseline up to 28 days after the last dose of study drug, approximately 25 months |
| Maximum Observed Serum Concentration (Cmax) of PF-05082566 | Maximum PF-05082566 observed serum concentration. | During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion |
| Maximum Observed Serum Concentration (Cmax) of MK-3475 | Maximum MK-3475 observed serum concentration. | During Cycle 5 Day 1 at pre-dose; and end of infusion. |
| Time for Cmax (Tmax) of PF-05082566 | Time to reach PF-05082566 maximum observed serum concentration. | During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion. |
| Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566 | PF-05082566 pre-dose concentration during multiple dosing | During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion. |
| Pre-dose Concentration During Multiple Dosing (Ctrough) of MK-3475 | MK-3475 pre-dose concentration during multiple dosing | During Cycle 5 Day 1 at pre-dose; and end of infusion. |
| Terminal Half-life （t½）of PF-05082566 | PF-05082566 terminal half-life | During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion. |
| Clearance (CL) of Study Drug of PF-05082566 | Clearance of PF-05082566 | During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion. |
| Volume of Distribution at Steady State (Vss) of PF-05082566 | PF-05082566 volume of distribution at steady state | During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion. |
| Area Under the Serum Concentration-time Curve From Time 0 to Time Tau, the Dosing Interval, Where Tau = 504 Hours (21 Days) [AUCtau] for PF-05082566 | PF-05082566 area under the serum concentration-time curve (AUC) from time 0 to time tau, the dosing interval, where tau = 504 hours (21 days) (AUCtau) | During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion. |
| Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | ADA blood samples were assayed for anti-PF-05082566 antibodies using a validated analytical method in compliance with Pfizer (anti-PF-05082566) standard operating procedures (SOPs). ADA data was listed and summarized for PF 05082566 by dose. Negative ADA: titer<6.23; Positive ADA: titer>=6.23.Treatment-induced ADA = ADA developed de novo (seroconversion) following biologic drug administration. Treatment-boosted ADA = pre-existing ADA that were boosted to a higher level following biologic drug administration. | Pre-dose (Day 1), Cycles 1, 3, 5, 7, and subsequently pre-dose (Day 1) every 2 cycles up to Cycle 12, and every 4 cycles thereafter |
| Number of Participants With Positive Anti-Drug Antibody (ADA) of MK-3475 | ADA blood samples were assayed for anti-MK-3475 antibodies using a validated analytical method in compliance with Merck (anti-MK-3475) SOPs. | Pre-dose in Cycles 1, 3, 5, 7 and subsequently pre dose every 2 cycles up to Cycle 12 and every 4 cycles thereafter and 28 days, and during follow-up (3 months and 6 months after the end of MK-3475 treatment). |
| Number of Participants With Objective Tumor Response | Objective response (OR) was defined as complete response (CR) or partial response (PR) according to RECIST version 1.1 from the date of first dose of study treatment until documented disease progression.CR = at least 2 determinations of CR at least 4 weeks apart and before progression; PR = at least 2 determinations of PR or better at least 4 weeks apart and before progression (and not qualifying for a CR); Progression of disease (PD) = progression<=12 weeks after the date of first dose of study treatment (and not qualifying for CR, PR, SD or non-CR/non-PD); Stable disease (SD) (applicable only to participants with measurable disease at baseline) = at least 1 SD assessment (or better)>=6 weeks after the date of first dose of study treatment and before progression (and not qualifying for CR or PR). Both CR and PR were confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. | Baseline, at Week 9, and then every 6 weeks up to 90 days after the last dose of study drug, approximately 27 months. For those patients who achieved a confirmed PR or CR, tumor assessments could be conducted as clinically indicated. |
| Los Angeles |
| California |
| 90095 |
| United States |
| UCLA Hematology-Oncology Clinic | Los Angeles | California | 90095 | United States |
| UCLA Oncology Center | Los Angeles | California | 90095 | United States |
| Smilow Cancer Center at Yale-New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| Smilow Cancer Hospital at Yale-New Haven | New Haven | Connecticut | 06510 | United States |
| South Texas Accelerated Research Therapeutics, LLC | San Antonio | Texas | 78229 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg |
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| FG002 | PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| FG003 | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| FG004 | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline analysis population included all participants who were assigned to study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| BG001 | PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| BG002 | PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| BG003 | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| BG004 | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose-Limiting Toxicities (DLT) of PF-05082566 in Combination With MK-3475 | Severity of adverse events (AEs) was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the purpose of dose escalation, any of the following AEs occurring during the DLT observation period that were attributable to one or both study drugs were classified as DLTs. 1) Hematologic: Grade 4 neutropenia; Febrile neutropenia, defined as absolute neutrophil count (ANC) <1000/mm3 with a single temperature of >38.3C(101F) or a sustained temperature of 38C (100.4F) for more than 1 hour; Grade>=3 neutropenic infection; Grade>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia. 2) Non hematologic: Grade>=3 toxicities (non-laboratory); Grade>=3 nausea, vomiting or diarrhea despite maximal medical therapy; Grade 4 aspartate aminotransferase (AST) and alanine aminotransferase (ALT). 3) Other (non-AST/ALT) non-hematologic Grade>=3 laboratory value. 4) Inability to complete 2 infusions of MK-3475 and PF-05082566 during the DLT observation period. | The DLT evaluable set was a subset of the safety analysis set and included all participants who were eligible, received both study treatments and who either experienced a DLT during the first 2 cycles of PF-05082566 or completed the 2 cycles' DLT observation period. | Posted | Number | Participants | First 2 cycles of treatment up to 24 months |
|
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities) | An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by National Cancer Institute (NCI) CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE. | The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received. | Posted | Number | Participants | Baseline up to 90 days after the last dose of study drug, approximately 27 months |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related) | An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE. | The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received. | Posted | Number | Participants | Baseline up to 90 days after the last dose of study drug, approximately 27 months |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related) | An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE. | The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received. | Posted | Number | Participants | Baseline up to 90 days after the last dose of study drug, approximately 27 months |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related) | An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE. | The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received. | Posted | Number | Participants | Baseline up to 90 days after the last dose of study drug, approximately 27 months |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology) | The hematology laboratory test included: absolute neutrophil count, hemoglobin, platelet count, white blood cell with differential, coagulation panel, urinalysis and pregnancy test. Laboratory results were categorical summarized according to the NCI-CTCAE criteria version 4.03. The total number of participants with hematology laboratory test was assessed. | The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received. | Posted | Number | Participants | Baseline up to 28 days after the last dose of study drug, approximately 25 months |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries) | The chemical laboratory test included: sodium, potassium, total calcium, creatinine, albumin, alanine aminotransferase, alanine aminotransferase, glucose, phosphorus, magnesium, total bilirubin, blood urea nitrogen, alkaline phosphatase, lactate dehydrogenase, immunoglobulin G, total protein, uric acid, thyroid function assessments, hepatitis B and C tests. Laboratory results were categorical summarized according to the NCI-CTCAE criteria version 4.03. The total number of participants with chemistry laboratory test was assessed. | The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received. | Posted | Number | Participants | Baseline up to 28 days after the last dose of study drug, approximately 25 months |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern | Vital sign summaries included all vital sign assessments from the on-treatment period. All vital sign parameters including blood pressure (BP) and weight were summarized using actual values and changes from baseline for each visit over time. The changes computed were the differences from baseline. The participants meeting criteria of potential clinical concern were judged by investigator. | The safety analysis set included all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than 1 study treatment, the participant was classified according to the first treatment received. | Posted | Number | Participants | Baseline up to 28 days after the last dose of study drug, approximately 25 months |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study | The ECOG shift from baseline to highest score during the on-treatment period was summarized by treatment group.ECOG Performance Status included 0, 1, 2, 3, and 4 grades. Grade 1 was Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature. Grade 2 was Ambulatory and capable of all self care but unable to carry out any work activities.Up and about more than 50% of waking hours. Grade 3 was capable of only limited self care, confined to bed or chair more than 50% of waking hours. Grade 4 was completely disabled. Cannot carry on any self care. Totally confined to bed or chair. | The safety analysis set included all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than 1 study treatment, the participant was classified according to the first treatment received. | Posted | Number | Participants | Baseline up to 28 days after the last dose of study drug, approximately 25 months |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Observed Serum Concentration (Cmax) of PF-05082566 | Maximum PF-05082566 observed serum concentration. | The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLOQ) for PF-05082566 or MK-3475. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Observed Serum Concentration (Cmax) of MK-3475 | Maximum MK-3475 observed serum concentration. | The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLOQ) for PF-05082566 or MK-3475. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | During Cycle 5 Day 1 at pre-dose; and end of infusion. |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Time for Cmax (Tmax) of PF-05082566 | Time to reach PF-05082566 maximum observed serum concentration. | The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475. | Posted | Median | Full Range | hour | During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion. |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566 | PF-05082566 pre-dose concentration during multiple dosing | The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLOQ) for PF-05082566 or MK-3475. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion. |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Pre-dose Concentration During Multiple Dosing (Ctrough) of MK-3475 | MK-3475 pre-dose concentration during multiple dosing | The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLOQ) for PF-05082566 or MK-3475. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | During Cycle 5 Day 1 at pre-dose; and end of infusion. |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Terminal Half-life （t½）of PF-05082566 | PF-05082566 terminal half-life | The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475. | Posted | Mean | Standard Deviation | hour | During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion. |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Clearance (CL) of Study Drug of PF-05082566 | Clearance of PF-05082566 | The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/hr/kg | During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion. |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Volume of Distribution at Steady State (Vss) of PF-05082566 | PF-05082566 volume of distribution at steady state | The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/kg | During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion. |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Serum Concentration-time Curve From Time 0 to Time Tau, the Dosing Interval, Where Tau = 504 Hours (21 Days) [AUCtau] for PF-05082566 | PF-05082566 area under the serum concentration-time curve (AUC) from time 0 to time tau, the dosing interval, where tau = 504 hours (21 days) (AUCtau) | The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg•hr/mL | During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion. |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566 | ADA blood samples were assayed for anti-PF-05082566 antibodies using a validated analytical method in compliance with Pfizer (anti-PF-05082566) standard operating procedures (SOPs). ADA data was listed and summarized for PF 05082566 by dose. Negative ADA: titer<6.23; Positive ADA: titer>=6.23.Treatment-induced ADA = ADA developed de novo (seroconversion) following biologic drug administration. Treatment-boosted ADA = pre-existing ADA that were boosted to a higher level following biologic drug administration. | The immunogenicity analysis set was a subset of the safety analysis set and included participants who have at least 1 ADA sample collected for either PF-05082566 or MK 3475. | Posted | Number | Participants | Pre-dose (Day 1), Cycles 1, 3, 5, 7, and subsequently pre-dose (Day 1) every 2 cycles up to Cycle 12, and every 4 cycles thereafter |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Anti-Drug Antibody (ADA) of MK-3475 | ADA blood samples were assayed for anti-MK-3475 antibodies using a validated analytical method in compliance with Merck (anti-MK-3475) SOPs. | The immunogenicity analysis set was a subset of the safety analysis set and included participants who have at least 1 ADA sample collected for either PF-05082566 or MK 3475. | Posted | Number | Participants | Pre-dose in Cycles 1, 3, 5, 7 and subsequently pre dose every 2 cycles up to Cycle 12 and every 4 cycles thereafter and 28 days, and during follow-up (3 months and 6 months after the end of MK-3475 treatment). |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Objective Tumor Response | Objective response (OR) was defined as complete response (CR) or partial response (PR) according to RECIST version 1.1 from the date of first dose of study treatment until documented disease progression.CR = at least 2 determinations of CR at least 4 weeks apart and before progression; PR = at least 2 determinations of PR or better at least 4 weeks apart and before progression (and not qualifying for a CR); Progression of disease (PD) = progression<=12 weeks after the date of first dose of study treatment (and not qualifying for CR, PR, SD or non-CR/non-PD); Stable disease (SD) (applicable only to participants with measurable disease at baseline) = at least 1 SD assessment (or better)>=6 weeks after the date of first dose of study treatment and before progression (and not qualifying for CR or PR). Both CR and PR were confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. | The full analysis set (FAS) included all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than 1 treatment the participant was classified according to the first treatment received. | Posted | Number | Participants | Baseline, at Week 9, and then every 6 weeks up to 90 days after the last dose of study drug, approximately 27 months. For those patients who achieved a confirmed PR or CR, tumor assessments could be conducted as clinically indicated. |
|
Baseline up to 90 days after the last dose of study drug, approximately 27 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. | 1 | 5 | 2 | 5 | 5 | 5 |
| EG001 | PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. | 0 | 3 | 1 | 3 | 3 | 3 |
| EG003 | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. | 0 | 3 | 2 | 3 | 3 | 3 |
| EG004 | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. | 0 | 9 | 5 | 9 | 9 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Oral discomfort | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Presbyoesophagus | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Administration site reaction | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Device breakage | Product Issues | MedDRA 20.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Breast tenderness | Reproductive system and breast disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pruritus genital | Reproductive system and breast disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hair texture abnormal | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
The study was terminated early due to strategic reasons before any expansion cohort patient was enrolled.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 20, 2017 | Feb 23, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| C577122 | utomilumab |
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided
| Male |
|
| Black |
|
| Asian |
|
| Other |
|
Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated. |
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg |
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG002 | PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG003 | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| OG004 | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG005 | Total | Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated. |
|
|
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg |
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG002 | PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG003 | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| OG004 | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG005 | Total | Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated. |
|
|
| PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg |
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG002 | PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG003 | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| OG004 | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG005 | Total | Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated. |
|
|
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG002 | PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG003 | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| OG004 | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG005 | Total | Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated. |
|
|
| OG002 | PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG003 | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| OG004 | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG005 | Total | Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated. |
|
|
| OG002 | PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG003 | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| OG004 | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG005 | Total | Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated. |
|
|
| OG002 | PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG003 | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| OG004 | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG005 | Total | Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated. |
|
|
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG002 | PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG003 | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| OG004 | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG005 | Total | Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated. |
|
|
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG003 | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| OG004 | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
|
|
| OG003 | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| OG004 | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
|
|
| OG003 | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| OG004 | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
|
|
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG003 | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| OG004 | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
|
|
| OG003 | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| OG004 | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
|
|
| OG003 | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| OG004 | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
|
|
| OG003 | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| OG004 | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
|
|
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.
| OG003 | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| OG004 | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
|
|
| PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg |
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG003 | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| OG004 | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
|
|
| OG002 | PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG003 | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| OG004 | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG005 | Total | Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated. |
|
|
PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG003 | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| OG004 | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG005 | Total | Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated. |
|
|
| OG001 | PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG002 | PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG003 | PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion. |
| OG004 | PF-05082566 5 mg/kg + MK-3475 2 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion. |
| OG005 | Total | Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated. |
|
|