Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Vaccines

Immunomodulating Agents

Tremelimumab

PF-06755992 will be administered on Day 1 of Cycles 1 and 2.

PF-06755992

PF-06755990 will be administered using a device on Day 29, 57 and 85 of each cycle.

PF-06755990

TDS-IM electroporation device and associated supplies will be used for PF-06755990 administration

TDS-IM Electroporation Device

PF-06753388 will be administered every 28 days.

PF-06801591 will be administered every 28 days.

PF-06801591

Combination of adenovirus (AdC68) + plasmid DNA (pDNA) + tremelimumab

PF-06753512

Pfizer CT.gov Call Center

The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of a vaccine-based immunotherapy regimen for patients with prostate cancer.

A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)

A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF ESCALATING DOSES OF A VACCINE-BASED IMMUNOTHERAPY REGIMEN (VBIR) FOR PROSTATE CANCER (PF-06753512)

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.

An AE was any untoward medical occurrence in a clinical investigation where participant administered a product; the event did not need to have a causal relationship with the treatment. A SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and non-serious AEs.

An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. Grades of AEs were defined by NCI CTCAE v 4.03. Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5= death related to AE. Treatment-emergent adverse events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

An AE was any untoward medical occurrence in a clinical investigation where participant administered a product; the event did not need to have a causal relationship with the treatment.

The following AEs occurring in the first 28 days following the first AdC68 vaccination and not related to disease/progression were DLTs: (a) hematologic (Cohorts 1A to 3A and Cohorts 6A to 9A): Grade 3 neutropenia lasting \>7 days, febrile neutropenia, Grade \>=3 neutropenic infection, Grade \>=3 thrombocytopenia, Grade \>=3 anemia lasting \>7 days, Grade \>=3 lymphopenia lasting \>14 days; (b) non-hematologic (all cohorts): Grade \>=3 laboratory abnormalities either associated with symptoms or associated with worsening of an existing condition or that suggested a new disease process or that required additional active management, Grade \>=3 toxicities, Grade 3 flu like symptoms lasting \>3 days, fever of \>40.0 degree Celsius lasting \>3 days. Other clinically important or persistent toxicities at discretion of investigator and Pfizer.

Laboratory abnormalities were graded per NCI CTCAE version 4.03 (Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) and those with at least 1 participant are presented here. Hematology parameters included hemoglobin, platelets, white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes.

Laboratory abnormalities were graded per NCI CTCAE version 4.03 (Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) and those with at least 1 participant are presented here. Chemistry parameters included aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen (or urea), creatinine, uric acid, glucose, albumin, phosphorous or phosphate, lactate dehydrogenase, lipase, bicarbonate or carbon dioxide, total protein, TSH (if abnormal, reflex free T4 and free T3).

Laboratory abnormalities were graded per NCI CTCAE version 4.03 (Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) and those with at least 1 participant are presented here. Urine parameters included urine protein and urine blood.

T cell response to PSA was determined by assaying peripheral blood mononuclear cell (PBMC) samples for cellular immune responses against PSA antigens and was determined as the frequency of interferon-gamma (IFN-γ) spot forming cells (SFC)/million PBMCs. Change from baseline at Cycle 1 Day 71 and at Cycle 2 Day 99 are presented here.

T cell response to PSCA was determined by assaying PBMC samples for cellular immune responses against PSCA antigens and was determined as the frequency of IFN-γ SFC/million PBMCs. Change from baseline at Cycle 1 Day 71 and at Cycle 2 Day 99 are presented here.

T cell response to PSMA was determined by assaying PBMC samples for cellular immune responses against PSMA antigens and was determined as the frequency of IFN-γ SFC/million PBMCs. Change from baseline at Cycle 1 Day 71 and at Cycle 2 Day 99 are presented here.

Cmax was defined as the maximum observed plasma concentration. Blood samples (approximately 3 mL whole blood) to provide at least 1 mL of serum for measurement of tremelimumab PK analysis were collected.

Tmax was defined as the time to reach maximum observed plasma concentration. Blood samples (approximately 3 mL whole blood) to provide at least 1 mL of serum for measurement of tremelimumab PK analysis were collected.

AUClast was defined as the area under the curve from time zero to last quantifiable concentration. Blood samples (approximately 3 mL whole blood) to provide at least 1 mL of serum for measurement of tremelimumab PK analysis were collected.

Pre-dose tremelimumab concentration on Cycle 2 Day 1 is presented here as Ctrough. Blood samples (approximately 3 mL whole blood) to provide at least 1 mL of serum for measurement of tremelimumab PK analysis were collected. Summary statistics of Ctrough were not calculated if number of observations above lower lit of quantification (NALQ)=0 or \<=3 participants had non-missing data.

Cmax was defined as the maximum observed plasma concentration. Blood samples (approximately 5 mL) to provide serum for the analysis of PF-06801591 concentrations were collected.

Tmax was defined as the time at which Cmax occurred. Blood samples (approximately 5 mL) to provide serum for the analysis of PF- 06801591 concentrations were collected.

AUClast was defined as the area under the curve from time zero to last quantifiable concentration. Blood samples (approximately 5 mL) to provide serum for the analysis of PF-06801591 concentrations were collected. The geometric mean and geometric coefficient of variation of AUClast for Cohort 9A were not presented because fewer than 3 participants had reportable parameter values.

Pre-dose PF-06801591 concentration on Cycle 2 Day 1 is presented here as Ctrough. Blood samples (approximately 3 mL whole blood) to provide at least 1 mL of serum for measurement of PF-06801591 PK analysis were collected.

Blood samples (approximately 5 mL) to provide at least 1 mL of serum to detect ADA were collected from participants enrolled in to Cohorts 3A to 9A and Cohorts 1B to 5B. Participants were considered ADA-positive if sample titer (log10) \>=1.48; participants were considered ADA-negative if sample titer (log10) \<1.48.

Treatment-induced ADA was defined as baseline titer missing or negative and participant had \>=1 post-treatment positive titer. Blood samples (approximately 5 mL) to provide at least 1 mL of serum to detect ADA were collected from participants enrolled in to Cohorts 3A to 9A and Cohorts 1B to 5B.

Only those samples tested positive for ADA were to be further tested for Nab. Blood samples (approximately 5 mL) to provide at least 1 mL of serum to detect NAb were collected from participants enrolled in to Cohorts 3A to 9A and Cohorts 1B to 5B. Nab against tremelimumab was not examined due to business reason.

Participants were considered ADA-positive if sample titer (log10) \>=99; Participants were considered ADA-negative if sample titer (log10) \<99. Blood samples (approximately 5 mL) to provide at least 1 mL of serum for detection of ADA against PF-06801591 were collected from participants enrolled in Cohorts 6A to 9A and Cohorts 3B and 5B.

Treatment-induced ADA was defined as baseline titer missing or negative and participant had \>=1 post-treatment positive titer. Blood samples (approximately 5 mL) to provide at least 1 mL of serum for detection of ADA against PF-06801591 were collected from participants enrolled in Cohorts 6A to 9A and Cohorts 3B and 5B.

Only those samples tested positive for ADA were to be further tested for Nab. Blood samples (approximately 5 mL) to provide at least 1 mL of serum for detection of NAb against PF-06801591 were collected from participants enrolled in Cohorts 6A to 9A and Cohorts 3B and 5B. Nab against PF-06801591 was not examined due to business reason.

ORR was defined as the percentage of participants with best overall response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v1.1. Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm) and no new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions.

DOR was defined as the time from first documentation of confirmed CR or PR to date of first documentation of progressive disease (PD) or death due to any cause according to RECIST v1.1. Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm) and no new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all measurable target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions. PD was defined as \>=20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm. Unequivocal progression of pre existing lesions for non-target disease.

Immune-related confirmed ORR was defined as the percentage of participants with objective response based assessment of confirmed immune related complete response (irCR) or confirmed immune related partial response (irPR) according to irRECIST v1.1. Per irRECIST v1.1: irCR was defined as complete disappearance of all lesions and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \<10 mm. irPR was defined as sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions must decrease \>=30%.

Immune-related confirmed DOR was defined as the time from first documentation of confirmed irCR or confirmed irPR to date of first documentation of immune related progressive disease (irPD) or death due to any cause according to irRECIST. Per irRECIST v1.1: irCR was defined as complete disappearance of all lesions and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \<10 mm. irPR was defined as sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions must decrease \>=30%. irPD was defined as sum of the diameters of target and new measurable lesions must increase \>=20%, confirmed by a repeat, consecutive observation at least 4 weeks from the date first documented.

Number of participants with bone progression per Prostate Cancer Clinical Trials Working Group 3 (PCWG3). Per PCWG3, progressing disease on bone scan was considered when at least two new lesions relative to the first post treatment scan was confirmed on a subsequent scan (6 or more weeks later).

Radiographic Progression Free Survival (rPFS) per RECIST v1.1. rPFS was defined as the time from first dose of study treatment to date of first documentation of radiographic PD or death due to any cause, whichever occurs first. Per RECIST v1.1, PD was defined as \>=20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm. Unequivocal progression of pre existing lesions for non-target disease. The Kaplan Meier estimate of median rPFS was presented here.

PSA-50 response rate was defined as the proportion of patients whose on-study PSA declined from baseline by at least 50% at two consecutive measurements at least 3 weeks apart, prior to other systematic anti-cancer therapy.

Duration of PSA-50 response was defined as the period from the first measurement when PSA-50 response was achieved to the measurement when PSA-50 response no longer held.

PSA Baseline is defined as the most recent non-missing value prior to dosing.

PSADT was defined as the natural log of 2 divided by the slope of the linear regression line of the natural log of PSA against time in month. Baseline has been calculated from the PSA values at screening and C1D1.

PSA slope was defined as the slope of the linear regression line of natural log of PSA against time in month. Baseline has been calculated from the PSA values at screening and C1D1.

PSA velocity was defined as the slope of the linear regression line of PSA against time in month. Baseline has been calculated from the PSA values at screening and C1D1.

PSADT was defined as the natural log of 2 divided by the slope of the linear regression line of the natural log of PSA against time in month. PSADT at the post-treatment visit was calculated from C1D1 and all post-treatment PSA values.

PSA slope was defined as the slope of the linear regression line of natural log of PSA against time in month. PSA slope at the post-treatment visit was calculated from C1D1 and all post-treatment PSA values.

PSA velocity was defined as the slope of the linear regression line of PSA against time in month. PSA velocity at the post-treatment visit was calculated from C1D1 and all post-treatment PSA values.

Pfizer

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.

Participants with mCRPC in Cohort 1A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 4x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. Following the 2 cycles, participants in Cohort 1A entered the maintenance phase and received pDNA 5 mg every 2 months starting from Month 10, as long as there was clinical benefit.

Cohort 1A: AdC68 4x10^11 VP + pDNA 5 mg

Participants with mCRPC in Cohort 2A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. Following the 2 cycles, participants in Cohort 2A entered the maintenance phase and received pDNA 5 mg every 2 months starting from Month 10, as long as there was clinical benefit.

Cohort 2A: AdC68 6x10^11 VP + pDNA 5 mg

Participants with mCRPC in Cohort 3A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 3A entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.

Cohort 3A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg

Participants with mCRPC in Cohort 6A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 6A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.

Cohort 6A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg

Participants with mCRPC in Cohort 7A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 7A entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.

Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg

Participants with mCRPC in Cohort 9A received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 40 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 9A entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 40 mg every 2 months starting from Month 10, as long as there was clinical benefit.

Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg

Participants with BCR of prostate cancer in Cohort 1B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg was also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 1B entered the maintenance phase and received pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.

Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg

Participants with mCRPC in Cohort 3B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 300 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 3B entered the maintenance phase and received PF-06801591 300 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.

Cohort 3B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg

Participants with BCR of prostate cancer in Cohort 5B received 2 repeated cycles (16 weeks each) of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycle 1 and 2, and pDNA 5 mg IM on Day 29, 57, and 85 of Cycle 1 and 2. On Day 1, 29, 57, and 85 of Cycle 1 and 2, tremelimumab 80 mg and PF-06801591 130 mg were also administered SC after the AdC68 or pDNA administration. Following the 2 cycles, participants in Cohort 5B entered the maintenance phase and received PF-06801591 130 mg every month starting from Month 9, as well as pDNA 5 mg and tremelimumab 80 mg every 2 months starting from Month 10, as long as there was clinical benefit.

Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race/Ethnicity, Customized

All enrolled participants who received at least one dose of one of the components of the regimen.

The study was terminated on 20 August 2020 by the sponsor. The decision to terminate this study was based on the results of a strategic evaluation of VBIR-1 within the current Pfizer oncology portfolio. This decision was not based on any safety or regulatory concerns with the treatment of participants with VBIR-1.

Pfizer ClinicalTrials.gov Call Center

Number of participants with all-causality AEs

Number of participants with treatment-related AEs

Number of participants with all-causality SAEs

Number of participants with treatment-related SAEs

This group included all mCRPC participants in the study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).

Cohort All mCRPC Patients

This group included mCRPC participants in 7A and 3B, treated at RP2D dose.

Cohort 7A and 3B Combined

Safety analysis set: all enrolled participants who received at least one dose of one of the components of the regimen. For this outcome measure, participants are grouped by disease type and treatment, as follows: Cohort All mCRPC Patients (all mCRPC participants), Cohort 1B (BCR with 1 immune checkpoint inhibitor \[ICI\]), Cohort 5B (BCR with 2 ICIs), and Cohort 7A and 3B Combined (mCRPC at recommended Phase 2 dose \[RP2D\] dose).

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Grade 3 or Grade 4 (all-causality)

Grade 3 or Grade 4 (treatment-related)

Grade 5 (all-causality)

Grade 5 (treatment-related)

This group included mCRPC participants in 7A and 3B.

Number of Participants With AEs as Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03) (Grade >= 3)

Number of participants with permanent discontinuations

Number of participants with temporary discontinuations

Number of participants with dose reductions

Safety analysis set: all enrolled participants who received at least one dose of one of the components of the regimen. or this outcome measure, participants are grouped by disease type and treatment, as follows: Cohort All mCRPC Patients (all mCRPC participants), Cohort 1B (BCR with 1 immune checkpoint inhibitor \[ICI\]), Cohort 5B (BCR with 2 ICIs), and Cohort 7A and 3B Combined (mCRPC at recommended Phase 2 dose \[RP2D\] dose).

Number of Participants With AEs Leading to Discontinuation or Dose Reduction

This group included all mCRPC participants in study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).

Per protocol analysis set: all enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 and did not have major protocol deviations during the 28 days after the first vaccination. For this outcome measure, participants are grouped by disease type and treatment, as follows: Cohort All mCRPC Patients (all mCRPC participants), Cohort 1B (BCR with 1 ICI), Cohort 5B (BCR with 2 ICIs), and Cohort 7A and 3B Combined (mCRPC at RP2D dose).

Number of Participants With Dose-Limiting Toxicities (DLTs)

Anemia

Hemoglobin increased

Lymphocyte count increased

Lymphopenia

Neutrophils (absolute)

Platelets

White blood cells

Safety analysis set: all enrolled participants who received at least one dose of one of the components of the regimen. For this outcome measure, participants are grouped by disease type and treatment, as follows: Cohort All mCRPC Patients (all mCRPC participants), Cohort 1B (BCR with 1 ICI), Cohort 5B (BCR with 2 ICIs), and Cohort 7A and 3B Combined (mCRPC at RP2D dose).

Number of Participants With Laboratory Abnormalities in Hematology (Grade 3 or 4)

Alanine aminotransferase

Alkaline phosphatase

Amylase

Aspartate aminotransferase

Bilirubin (total)

Creatinine

Hypercalcemia

Hyperglycemia

Hyperkalemia

Hypermagnesemia

Hypernatremia

Hypoalbuminemia

Hypocalcemia

Hypoglycemia

Hypokalemia

Hypomagnesemia

Hyponatremia

Hypophosphatemia

Lipase

This group includes all mCRPC participants in study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, 3B).

This group includes mCRPC participants in 7A and 3B.

Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4)

Number of Participants With Laboratory Abnormalities in Urinalysis (Grade 3 or 4)

Cycle 1 Day 1 Compared With Cycle 1 Day 71

Cycle 2 Day 1 Compared With Cycle 2 Day 99

All enrolled participants in Part A who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. Number of Participants Analyzed = number of participants evaluable for this OM; Number Analyzed = number of participants evaluable for this OM at the time point specified.

Change From Baseline in T Cell Response to Prostate Specific Antigen (PSA) in Part A

Change From Baseline in T Cell Response to Prostate Stem Cell Antigen (PSCA) in Part A

Change From Baseline in T Cell Response to Prostate Specific Membrane Antigen (PSMA) in Part A

All enrolled participants treated in Part A who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment. Participants in Part 1 Cohort 3A, 6A, 7A, and 9A were treated with tremelimumab, thus included in this outcome measure. Summary statistics for Cohort 6A, 7A, and 9A are not presented since no participants had reportable parameter values.

Maximum Observed Plasma Concentration (Cmax) of Tremelimumab in Part A

All enrolled participants treated in Part A who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment. Participants in Part 1 Cohort 3, 6, 7, and 9 were treated with tremelimumab, thus included in this outcome measure. Summary statistics for Cohort 6A, 7A, and 9A are not presented since no participants had reportable parameter values.

Time to Reach Maximum Observed Plasma Concentration (Tmax) of Tremelimumab in Part A

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Tremelimumab in Part A

PK parameter analysis population: all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment. Participants in Cohort 3A, 6A, 7A, 9A, 1B, 3B, and 5B were treated with tremelimumab, thus included in this outcome measure. Number of Participants Analyzed = Number of participants who had non-missing data and were evaluable for this OM.

Trough Concentrations (Ctrough) After Multiple Dosing of Tremelimumab

All enrolled participants treated in Part A who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment. Participants in Part 1 Cohort 6A, 7A, and 9A were treated with PF-06801591, thus included in this outcome measure.

Cmax of PF-06801591 in Part A

Tmax of PF-06801591 in Part A

AUClast of PF-06801591 in Part A

PK parameter analysis population: all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest and who had no major protocol deviations influencing the PK assessment. Participants in Cohort 6A, 7A, 9A, 3B, and 5B were treated with PF-06801591, thus included in this outcome measure.

Ctrough of PF-06801591

This group included all mCRPC participants in study who received tremelimumab (Cohort 3A, 6A, 7A, 9A, 3B).

All mCRPC Patients

This group included all BCR participants in study who received tremelimumab (Cohort 1B and 5B).

All BCR Patients

This group included participants in 3A, 6A, 7A, 1B, 3B and 5B who received tremelimumab 80 mg.

Cohort 3A, 6A, 7A, 1B, 3B and 5B Combined

All enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, participants are grouped by disease type and tremelimumab dose, as follows: All mCRPC Patients, All BCR Patients, Cohort 9A (tremelimumab 40 mg), and Cohort 3A, 6A, 7A, 1B, 3B, and 5B Combined (tremelimumab 80 mg).

Number of Participants With Anti-Drug Antibody (ADA) Against Tremelimumab

All enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, participants are grouped by disease type and tremelimumab dose as follows: All mCRPC Patients, All BCR Patients, Cohort 9A (tremelimumab 40 mg), and Cohort 3A, 6A, 7A, 1B, 3B, and 5B Combined (tremelimumab 80 mg).

Titer of Treatment-Induced ADA Against Tremelimumab

Number of Participants With Neutralizing Antibody (NAb) Against Tremelimumab

Titer of Treatment-Induced NAb Against Tremelimumab

This group included all mCRPC participants in study who received PF-06801591 (Cohort 6A, 7A, 9A, and 3B).

This group included all BCR participants in study who received PF-06801591 (Cohort 5B).

This group included mCRPC participants in 7A and 3B, who received PF-06801591 300 mg.

This group included participants in 6A, 9A, and 5B, who received PF-06801591 130 mg.

Cohort 6A, 9A, and 5B Combined

All enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, participants are grouped by disease type and PF-06801591 dose as follows: All mCRPC Patients, All BCR Patients, Cohort 7A and 3B Combined (PF-06801591 300 mg), and Cohort 6A, 9A, and 5B Combined (PF-06801591 130 mg).

Number of Participants With ADA Against PF-06801591

This group included all mCRPC participants in study who received PF-06801591(Cohort 6A, 7A, 9A, and 3B).

All enrolled participants who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, participants are grouped by disease type and PF-06801591 dose, as follows: All mCRPC Patients, All BCR Patients, Cohort 7A and 3B Combined (PF-06801591 300 mg), and Cohort 6A, 9A, and 5B Combined (PF-06801591 130 mg).

Titer of Treatment-Induced ADA Against PF-06801591

Number of Participants With NAb Against PF-06801591

Titer of Treatment-Induced NAb Against PF-06801591

This group included all mCRPC participants in study (Cohort 1A, 2A, 3A, 6A, 7A, 9A, and 3B).

All enrolled participants in Cohort 1A, 2A, 3A, 6A, 7A, 9A, and 3B who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment and must have at least 1 valid and determinate assay result related to the proposed analysis.

Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Cohort 7A and 3B Combined and All mCRPC Patients

Spots Global Cancer Trial Database for A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)

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