Prostatic NeoplasmsPhase 1NCT02616185

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

A Phase 1 study testing PF-06755992, PF-06755990 and TDS-IM Electroporation Device in people with Prostatic Neoplasms, run by Pfizer at 19 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostatic Neoplasms
What is being tested?: PF-06755992, PF-06755990 and TDS-IM Electroporation Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 19 sitesUnited States
Study dates: 30 Dec 2015to 23 Feb 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Histological or cytological diagnosis of prostate cancer
Adequate bone marrow, kidney and liver function
Hormone sensitive relapsing prostate cancer after definitive local therapy (biochemical relapse) OR
Failed prior therapy with a novel hormone (e.g. enzalutamide, abiraterone) with documented progressive disease (post-novel hormone therapy CRPC)

Who cannot join

ECOG performance status greater than or equal to 2
Concurrent immunotherapy for prostate cancer
History of or active autoimmune disorders (including but not limited to: myasthenia gravis, thyroiditis, pneumonitis, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, scleroderma) and other conditions that disorganize or alter the immune system.
History of inflammatory bowel disease.
Current use of any implanted electronic stimulation device
For biochemically relapsed patients, no concurrent use of ADT or orchiectomy and no known prior or current evidence of any metastatic involvement of distant organs
For post-novel hormone patients, no concurrent treatment with a secondary hormone (e.g. enzalutamide, abiraterone), no metastasis to the liver or brain

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Duke University Medical Center
Durham, North Carolina, 27710
Northwell Health
Lake Success, New York, 11042
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Garden State Urology
Morristown, New Jersey, 07960
Morristown Medical Center
Morristown, New Jersey, 07960
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, 06510
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, 06511
Memorial Sloan-Kettering Cancer Center 53rd Street
New York, New York, 10022
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan-Kettering Cancer Center, Sidney Kimmel Center
New York, New York, 10065
GU Research Network
Omaha, Nebraska, 68130
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Garden State Urology
Rockaway, New Jersey, 07866
Seattle Cancer Care Alliance
Seattle, Washington, 98109
University of Washington Medical Center
Seattle, Washington, 98195
Banner-University Medical Center Tucson
Tucson, Arizona, 85719
The University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719
Garden State Urology
Whippany, New Jersey, 07981

Other trials in United States

About this study

Official title: 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)

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

Conditions: Prostatic Neoplasms
Being tested: PF-06755992, PF-06755990, TDS-IM Electroporation Device, Tremelimumab, PF-06801591
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-06755992Biological
Also called AdC68
PF-06755992 will be administered on Day 1 of Cycles 1 and 2.
PF-06755990Biological
Also called pDNA
PF-06755990 will be administered using a device on Day 29, 57 and 85 of each cycle.
TDS-IM Electroporation DeviceDevice
TDS-IM electroporation device and associated supplies will be used for PF-06755990 administration
TremelimumabBiological
Also called PF-06753388
PF-06753388 will be administered every 28 days.
PF-06801591Biological
PF-06801591 will be administered every 28 days.
PF-06753512Biological
Also called VBIR-1 or PrCa VBIR
Combination of adenovirus (AdC68) + plasmid DNA (pDNA) + tremelimumab

Study groups in NCT02616185
Study group	Role	What they receive
Dose Escalation	Experimental	PF-06753512 Receives: Biological: PF-06755992; Biological: PF-06755990; Device: TDS-IM Electroporation Device; Biological: Tremelimumab; Biological: PF-06801591; Biological: PF-06753512

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Measured: Baseline up to 6 months after End of Treatment (EOT; 52 months in maximum)
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)
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.
Measured: Baseline up to 6 months after EOT (52 months in maximum)
Number of Participants With AEs Leading to Discontinuation or Dose Reduction
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.
Measured: Baseline up to 6 months after EOT (52 months in maximum)
Number of Participants With Dose-Limiting Toxicities (DLTs)
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.
Measured: The first 28 days following the first AdC68 vaccination (on Cycle 1 Day 1)

Secondary outcomes (37)

Number of Participants With Laboratory Abnormalities in Hematology (Grade 3 or 4)
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.
Measured: Baseline up to 6 months after EOT (52 months in maximum)
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4)
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).
Measured: Baseline up to 6 months after EOT (52 months in maximum)
Number of Participants With Laboratory Abnormalities in Urinalysis (Grade 3 or 4)
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.
Measured: Baseline up to 6 months after EOT (52 months in maximum)
Change From Baseline in T Cell Response to Prostate Specific Antigen (PSA) in Part A
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.
Measured: At screening; Cycle 1: at Day 1, Day 15, Day 29, Day 43, Day 71; Cycle 2: at Day 1, Day 29, and Day 99; at the EOT visit, and 2, 4 and 6 months after EOT.
Change From Baseline in T Cell Response to Prostate Stem Cell Antigen (PSCA) in Part A
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.
Measured: At screening; Cycle 1: at Day 1, Day 15, Day 29, Day 43, Day 71; Cycle 2: at Day 1, Day 29, and Day 99; at the EOT visit, and 2, 4 and 6 months after EOT.
Change From Baseline in T Cell Response to Prostate Specific Membrane Antigen (PSMA) in Part A
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.
Measured: At screening; Cycle 1: at Day 1, Day 15, Day 29, Day 43, Day 71; Cycle 2: at Day 1, Day 29, and Day 99; at the EOT visit, and 2, 4 and 6 months after EOT.
Maximum Observed Plasma Concentration (Cmax) of Tremelimumab in Part A
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.
Measured: Cycle 1: at Day 1 pre-dose, any time between 48 to 120 hr, approximately 168 hr, 336 hr, and 504 hr, at pre-dose on Day 29, Day 57, and Day 85; Cycle 2: at pre-dose on Day 1 and Day 29; at EOT visit, and 2, 4 and 6 months after EOT.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Tremelimumab in Part A
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.
Measured: Cycle 1: at Day 1 pre-dose, any time between 48 to 120 hr, approximately 168 hr, 336 hr, and 504 hr, at pre-dose on Day 29, Day 57, and Day 85; Cycle 2: at pre-dose on Day 1 and Day 29; at EOT visit, and 2, 4 and 6 months after EOT.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Tremelimumab in Part A
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.
Measured: Cycle 1: at Day 1 pre-dose, any time between 48 to 120 hr, approximately 168 hr, 336 hr, and 504 hr, at pre-dose on Day 29, Day 57, and Day 85; Cycle 2: at pre-dose on Day 1 and Day 29; at EOT visit, and 2, 4 and 6 months after EOT.
Trough Concentrations (Ctrough) After Multiple Dosing of Tremelimumab
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.
Measured: Pre-dose on Cycle 2 Day 1
Cmax of PF-06801591 in Part A
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.
Measured: Cycle 1: at Day 1 pre-dose, any time between 48 to 120 hr, approximately 168 hr, 336 hr, and 504 hr, at pre-dose on Day 29, Day 57, and Day 85; Cycle 2: at pre-dose on Day 1 and Day 29; at EOT visit, and 2, 4 and 6 months after EOT.
Tmax of PF-06801591 in Part A
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.
Measured: Cycle 1: at Day 1 pre-dose, any time between 48 to 120 hr, approximately 168 hr, 336 hr, and 504 hr, at pre-dose on Day 29, Day 57, and Day 85; Cycle 2: at pre-dose on Day 1 and Day 29; at EOT visit, and 2, 4 and 6 months after EOT.
AUClast of PF-06801591 in Part A
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.
Measured: Cycle 1: at Day 1 pre-dose, any time between 48 to 120 hr, approximately 168 hr, 336 hr, and 504 hr, at pre-dose on Day 29, Day 57, and Day 85; Cycle 2: at pre-dose on Day 1 and Day 29; at EOT visit, and 2, 4 and 6 months after EOT.
Ctrough of PF-06801591
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.
Measured: Pre-dose on Cycle 2 Day 1
Number of Participants With Anti-Drug Antibody (ADA) Against Tremelimumab
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.
Measured: Cycle 1: at Day 1, Day 29, and Day 85; Cycle 2: at Day 29; at the EOT visit, and 2, 4 and 6 months after EOT. Samples collected on dosing days were obtained within 6 hours prior to tremelimumab dosing.
Titer of Treatment-Induced ADA Against Tremelimumab
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.
Measured: Cycle 1: at Day 1, Day 29, and Day 85; Cycle 2: at Day 29; at the EOT visit, and 2, 4 and 6 months after EOT. Samples collected on dosing days were obtained within 6 hours prior to tremelimumab dosing.
Number of Participants With Neutralizing Antibody (NAb) Against Tremelimumab
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.
Measured: Cycle 1: at Day 1, Day 29, and Day 85; Cycle 2: at Day 29; at the EOT visit, and 2, 4 and 6 months after EOT. Samples collected on dosing days were obtained within 6 hours prior to tremelimumab dosing.
Titer of Treatment-Induced NAb Against Tremelimumab
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.
Measured: Cycle 1: at Day 1, Day 29, and Day 85; Cycle 2: at Day 29; at the EOT visit, and 2, 4 and 6 months after EOT. Samples collected on dosing days were obtained within 6 hours prior to tremelimumab dosing.
Number of Participants With ADA Against PF-06801591
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.
Measured: Cycle 1: at Day 1, Day 29, and Day 85; Cycle 2: at Day 29; at the EOT visit, and 2, 4 and 6 months after EOT. Samples collected on dosing days were obtained within 6 hours prior to PF-06801591 dosing.
Titer of Treatment-Induced ADA Against PF-06801591
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.
Measured: Cycle 1: at Day 1, Day 29, and Day 85; Cycle 2: at Day 29; at the EOT visit, and 2, 4 and 6 months after EOT. Samples collected on dosing days were obtained within 6 hours prior to PF-06801591 dosing.
Number of Participants With NAb Against PF-06801591
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.
Measured: Cycle 1: at Day 1, Day 29, and Day 85; Cycle 2: at Day 29; at the EOT visit, and 2, 4 and 6 months after EOT. Samples collected on dosing days were obtained within 6 hours prior to PF-06801591 dosing.
Titer of Treatment-Induced NAb Against PF-06801591
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.
Measured: Cycle 1: at Day 1, Day 29, and Day 85; Cycle 2: at Day 29; at the EOT visit, and 2, 4 and 6 months after EOT. Samples collected on dosing days were obtained within 6 hours prior to PF-06801591 dosing.
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
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.
Measured: Baseline up to 6 months after EOT (52 months in maximum)
Duration of Response (DOR) by RECIST v1.1 in Cohort 7A and 3B Combined and All mCRPC Patients
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.
Measured: Baseline up to 6 months after EOT (52 months in maximum)
Immune-Related Confirmed ORR by Immune Related Response Evaluation Criteria in Solid Tumors Version 1.1 (irRECIST v1.1) in Cohort 7A and 3B Combined and All mCRPC Patients
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%.
Measured: Baseline up to 6 months after EOT (52 months in maximum)
Immune-Related Confirmed DOR by irRECIST v1.1 in Cohort 7A and 3B Combined and All mCRPC Patients
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.
Measured: Baseline up to 6 months after EOT (52 months in maximum)
Number of Patients With Bone Progression Per Prostrate Cancer Working Group 3 (PCWG3) Criteria in Cohort 7A and 3B Combined
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).
Measured: Baseline up to 6 months after EOT (52 months in maximum)
Radiographic Progression Free Survival (rPFS) Per RECIST v1.1 in Cohort 7A and 3B Combined , All mCRPC Patients, Cohort 1B, and Cohort 5B
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.
Measured: Baseline up to 6 months after EOT (52 months in maximum)
Number of Participants Achieving Central PSA Response >= 50% Decline From Baseline (PSA-50) in Part B
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.
Measured: At screening; Cycle 1 and 2: at Day 1, Day 29, Day 57, and Day 85; at the EOT visit, and 1, 2, 4 and 6 months after EOT.
Duration of PSA-50 Response in Part B
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.
Measured: Days 1, 29, 57 of Cycle 1 and Cycle 2.
Baseline for PSA in Part B
PSA Baseline is defined as the most recent non-missing value prior to dosing.
Measured: At screening and Cycle 1 Day 1.
Baseline for PSA Doubling Time (PSADT) in Part B
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.
Measured: At screening and Cycle 1 Day 1.
Baseline for PSA Slope in Part B
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.
Measured: At screening and Cycle 1 Day 1.
Baseline for PSA Velocity in Part B
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.
Measured: At screening and Cycle 1 Day 1.
Change in PSADT at Post-Treatment Visit From Baseline in Part B
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.
Measured: At screening; Cycle 1 and 2: at Day 1, Day 29, Day 57, and Day 85; at the EOT visit, and 1, 2, 4 and 6 months after EOT.
Change in PSA Slope at Post-Treatment Visit From Baseline in Part B
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.
Measured: At screening; Cycle 1 and 2: at Day 1, Day 29, Day 57, and Day 85; at the EOT visit, and 1, 2, 4 and 6 months after EOT.
Change in PSA Velocity at Post-Treatment Visit From Baseline in Part B
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.
Measured: At screening; Cycle 1 and 2: at Day 1, Day 29, Day 57, and Day 85; at the EOT visit, and 1, 2, 4 and 6 months after EOT.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Dec 201523 Feb 2021

First posted26 Nov 2015 (estimated)
Study start30 Dec 2015
Primary completion23 Feb 2021
Study completion23 Feb 2021

Why it stopped: Due to strategic evaluation of PF-06753512 (VBIR-1) within context of Pfizer's oncology portfolio, decision not based on any safety or regulatory concerns.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02616185
Sponsor's protocol ID: B7791001
Other IDs: PRCA VBIR FIP STUDY
Status last verified: Jan 2023
First submitted: 24 Nov 2015
Last updated: 2 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: 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.

Publications

Autio KA, Higano CS, Nordquist L, Appleman LJ, Zhang T, Zhu XH, Babiker H, Vogelzang NJ, Prasad SM, Schweizer MT, Madan RA, Billotte S, Cavazos N, Bogg O, Li R, Chan K, Cho H, Kaneda M, Wang IM, Zheng J, Tang SY, Hollingsworth R, Kern KA, Petrylak DP. First-in-human, phase 1 study of PF-06753512, a vaccine-based immunotherapy regimen (VBIR), in non-metastatic hormone-sensitive biochemical recurrence and metastatic castration-resistant prostate cancer (mCRPC). J Immunother Cancer. 2023 Mar;11(3):e005702. doi: 10.1136/jitc-2022-005702.
PubMed 36948505

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Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma

All Prostatic Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT02616185
Acronym / sponsor ID: B7791001
Conditions: Prostatic Neoplasms
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to strategic evaluation of PF-06753512 (VBIR-1) within context of Pfizer's oncology portfolio, decision not based on any safety or regulatory concerns.
Enrolment: 91 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 30 Dec 2015 (actual)
Primary completion: 23 Feb 2021 (actual)
Study completion: 23 Feb 2021 (actual)
First posted: 26 Nov 2015 (estimated)
Results: Posted 2 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Dose Escalation	Experimental	Biological: PF-06755992, Biological: PF-06755990, Device: TDS-IM Electroporation Device, Biological: Tremelimumab, Biological: PF-06801591, Biological: PF-06753512PF-06753512

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Histological or cytological diagnosis of prostate cancer
Adequate bone marrow, kidney and liver function
Hormone sensitive relapsing prostate cancer after definitive local therapy (biochemical relapse) OR
Failed prior therapy with a novel hormone (e.g. enzalutamide, abiraterone) with documented progressive disease (post-novel hormone therapy CRPC)

Key exclusion criteria (7 listed)

ECOG performance status greater than or equal to 2
Concurrent immunotherapy for prostate cancer
History of or active autoimmune disorders (including but not limited to: myasthenia gravis, thyroiditis, pneumonitis, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, scleroderma) and other conditions that disorganize or alter the immune system.
History of inflammatory bowel disease.
Current use of any implanted electronic stimulation device

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-06755992Also: AdC68PF-06755992 will be administered on Day 1 of Cycles 1 and 2.	Biological	Dose Escalation
PF-06755990Also: pDNAPF-06755990 will be administered using a device on Day 29, 57 and 85 of each cycle.	Biological	Dose Escalation
TDS-IM Electroporation DeviceTDS-IM electroporation device and associated supplies will be used for PF-06755990 administration	Device	Dose Escalation
TremelimumabAlso: PF-06753388PF-06753388 will be administered every 28 days.	Biological	Dose Escalation
PF-06801591PF-06801591 will be administered every 28 days.	Biological	Dose Escalation
PF-06753512Also: VBIR-1 or PrCa VBIRCombination of adenovirus (AdC68) + plasmid DNA (pDNA) + tremelimumab	Biological	Dose Escalation

Primary outcome

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to 6 months after End of Treatment (EOT; 52 months in maximum)
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.
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)
Time frame: Baseline up to 6 months after EOT (52 months in maximum)
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.
Number of Participants With AEs Leading to Discontinuation or Dose Reduction
Time frame: Baseline up to 6 months after EOT (52 months in maximum)
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.
Number of Participants With Dose-Limiting Toxicities (DLTs)
Time frame: The first 28 days following the first AdC68 vaccination (on Cycle 1 Day 1)
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.

37 secondary outcomes

Number of Participants With Laboratory Abnormalities in Hematology (Grade 3 or 4)
Time frame: Baseline up to 6 months after EOT (52 months in maximum)
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4)
Time frame: Baseline up to 6 months after EOT (52 months in maximum)
Number of Participants With Laboratory Abnormalities in Urinalysis (Grade 3 or 4)
Time frame: Baseline up to 6 months after EOT (52 months in maximum)
Change From Baseline in T Cell Response to Prostate Specific Antigen (PSA) in Part A
Time frame: At screening; Cycle 1: at Day 1, Day 15, Day 29, Day 43, Day 71; Cycle 2: at Day 1, Day 29, and Day 99; at the EOT visit, and 2, 4 and 6 months after EOT.
Change From Baseline in T Cell Response to Prostate Stem Cell Antigen (PSCA) in Part A
Time frame: At screening; Cycle 1: at Day 1, Day 15, Day 29, Day 43, Day 71; Cycle 2: at Day 1, Day 29, and Day 99; at the EOT visit, and 2, 4 and 6 months after EOT.
Change From Baseline in T Cell Response to Prostate Specific Membrane Antigen (PSMA) in Part A
Time frame: At screening; Cycle 1: at Day 1, Day 15, Day 29, Day 43, Day 71; Cycle 2: at Day 1, Day 29, and Day 99; at the EOT visit, and 2, 4 and 6 months after EOT.
Maximum Observed Plasma Concentration (Cmax) of Tremelimumab in Part A
Time frame: Cycle 1: at Day 1 pre-dose, any time between 48 to 120 hr, approximately 168 hr, 336 hr, and 504 hr, at pre-dose on Day 29, Day 57, and Day 85; Cycle 2: at pre-dose on Day 1 and Day 29; at EOT visit, and 2, 4 and 6 months after EOT.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Tremelimumab in Part A
Time frame: Cycle 1: at Day 1 pre-dose, any time between 48 to 120 hr, approximately 168 hr, 336 hr, and 504 hr, at pre-dose on Day 29, Day 57, and Day 85; Cycle 2: at pre-dose on Day 1 and Day 29; at EOT visit, and 2, 4 and 6 months after EOT.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Tremelimumab in Part A
Time frame: Cycle 1: at Day 1 pre-dose, any time between 48 to 120 hr, approximately 168 hr, 336 hr, and 504 hr, at pre-dose on Day 29, Day 57, and Day 85; Cycle 2: at pre-dose on Day 1 and Day 29; at EOT visit, and 2, 4 and 6 months after EOT.
Trough Concentrations (Ctrough) After Multiple Dosing of Tremelimumab
Time frame: Pre-dose on Cycle 2 Day 1
Cmax of PF-06801591 in Part A
Time frame: Cycle 1: at Day 1 pre-dose, any time between 48 to 120 hr, approximately 168 hr, 336 hr, and 504 hr, at pre-dose on Day 29, Day 57, and Day 85; Cycle 2: at pre-dose on Day 1 and Day 29; at EOT visit, and 2, 4 and 6 months after EOT.
Tmax of PF-06801591 in Part A
Time frame: Cycle 1: at Day 1 pre-dose, any time between 48 to 120 hr, approximately 168 hr, 336 hr, and 504 hr, at pre-dose on Day 29, Day 57, and Day 85; Cycle 2: at pre-dose on Day 1 and Day 29; at EOT visit, and 2, 4 and 6 months after EOT.
AUClast of PF-06801591 in Part A
Time frame: Cycle 1: at Day 1 pre-dose, any time between 48 to 120 hr, approximately 168 hr, 336 hr, and 504 hr, at pre-dose on Day 29, Day 57, and Day 85; Cycle 2: at pre-dose on Day 1 and Day 29; at EOT visit, and 2, 4 and 6 months after EOT.
Ctrough of PF-06801591
Time frame: Pre-dose on Cycle 2 Day 1
Number of Participants With Anti-Drug Antibody (ADA) Against Tremelimumab
Time frame: Cycle 1: at Day 1, Day 29, and Day 85; Cycle 2: at Day 29; at the EOT visit, and 2, 4 and 6 months after EOT. Samples collected on dosing days were obtained within 6 hours prior to tremelimumab dosing.
Titer of Treatment-Induced ADA Against Tremelimumab
Time frame: Cycle 1: at Day 1, Day 29, and Day 85; Cycle 2: at Day 29; at the EOT visit, and 2, 4 and 6 months after EOT. Samples collected on dosing days were obtained within 6 hours prior to tremelimumab dosing.
Number of Participants With Neutralizing Antibody (NAb) Against Tremelimumab
Time frame: Cycle 1: at Day 1, Day 29, and Day 85; Cycle 2: at Day 29; at the EOT visit, and 2, 4 and 6 months after EOT. Samples collected on dosing days were obtained within 6 hours prior to tremelimumab dosing.
Titer of Treatment-Induced NAb Against Tremelimumab
Time frame: Cycle 1: at Day 1, Day 29, and Day 85; Cycle 2: at Day 29; at the EOT visit, and 2, 4 and 6 months after EOT. Samples collected on dosing days were obtained within 6 hours prior to tremelimumab dosing.
Number of Participants With ADA Against PF-06801591
Time frame: Cycle 1: at Day 1, Day 29, and Day 85; Cycle 2: at Day 29; at the EOT visit, and 2, 4 and 6 months after EOT. Samples collected on dosing days were obtained within 6 hours prior to PF-06801591 dosing.
Titer of Treatment-Induced ADA Against PF-06801591
Time frame: Cycle 1: at Day 1, Day 29, and Day 85; Cycle 2: at Day 29; at the EOT visit, and 2, 4 and 6 months after EOT. Samples collected on dosing days were obtained within 6 hours prior to PF-06801591 dosing.
Number of Participants With NAb Against PF-06801591
Time frame: Cycle 1: at Day 1, Day 29, and Day 85; Cycle 2: at Day 29; at the EOT visit, and 2, 4 and 6 months after EOT. Samples collected on dosing days were obtained within 6 hours prior to PF-06801591 dosing.
Titer of Treatment-Induced NAb Against PF-06801591
Time frame: Cycle 1: at Day 1, Day 29, and Day 85; Cycle 2: at Day 29; at the EOT visit, and 2, 4 and 6 months after EOT. Samples collected on dosing days were obtained within 6 hours prior to PF-06801591 dosing.
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
Time frame: Baseline up to 6 months after EOT (52 months in maximum)
Duration of Response (DOR) by RECIST v1.1 in Cohort 7A and 3B Combined and All mCRPC Patients
Time frame: Baseline up to 6 months after EOT (52 months in maximum)
Immune-Related Confirmed ORR by Immune Related Response Evaluation Criteria in Solid Tumors Version 1.1 (irRECIST v1.1) in Cohort 7A and 3B Combined and All mCRPC Patients
Time frame: Baseline up to 6 months after EOT (52 months in maximum)
Immune-Related Confirmed DOR by irRECIST v1.1 in Cohort 7A and 3B Combined and All mCRPC Patients
Time frame: Baseline up to 6 months after EOT (52 months in maximum)
Number of Patients With Bone Progression Per Prostrate Cancer Working Group 3 (PCWG3) Criteria in Cohort 7A and 3B Combined
Time frame: Baseline up to 6 months after EOT (52 months in maximum)
Radiographic Progression Free Survival (rPFS) Per RECIST v1.1 in Cohort 7A and 3B Combined , All mCRPC Patients, Cohort 1B, and Cohort 5B
Time frame: Baseline up to 6 months after EOT (52 months in maximum)
Number of Participants Achieving Central PSA Response >= 50% Decline From Baseline (PSA-50) in Part B
Time frame: At screening; Cycle 1 and 2: at Day 1, Day 29, Day 57, and Day 85; at the EOT visit, and 1, 2, 4 and 6 months after EOT.
Duration of PSA-50 Response in Part B
Time frame: Days 1, 29, 57 of Cycle 1 and Cycle 2.
Baseline for PSA in Part B
Time frame: At screening and Cycle 1 Day 1.
Baseline for PSA Doubling Time (PSADT) in Part B
Time frame: At screening and Cycle 1 Day 1.
Baseline for PSA Slope in Part B
Time frame: At screening and Cycle 1 Day 1.
Baseline for PSA Velocity in Part B
Time frame: At screening and Cycle 1 Day 1.
Change in PSADT at Post-Treatment Visit From Baseline in Part B
Time frame: At screening; Cycle 1 and 2: at Day 1, Day 29, Day 57, and Day 85; at the EOT visit, and 1, 2, 4 and 6 months after EOT.
Change in PSA Slope at Post-Treatment Visit From Baseline in Part B
Time frame: At screening; Cycle 1 and 2: at Day 1, Day 29, Day 57, and Day 85; at the EOT visit, and 1, 2, 4 and 6 months after EOT.
Change in PSA Velocity at Post-Treatment Visit From Baseline in Part B
Time frame: At screening; Cycle 1 and 2: at Day 1, Day 29, Day 57, and Day 85; at the EOT visit, and 1, 2, 4 and 6 months after EOT.

Results and safety

Results posted to the registry on 2 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1A: Adenovirus C68 (AdC68) 4x10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg	3	2
Cohort 2A: AdC68 6x10^11 VP + pDNA 5 mg	4	3
Cohort 3A: AdC68 6x10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 80 mg	6	3
Cohort 6A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg	8	3
Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg	14	5
Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg	3	2
Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg	20	12
Cohort 3B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg	18	5
Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg	15	9

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

Time frame: Baseline up to 6 months after End of Treatment (EOT; 52 months in maximum). Count of participants. Unit: Participants

Measure	Cohort All mCRPC Patients n = 56	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n = 20	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n = 15	Cohort 7A and 3B Combined n = 32
Number of participants with all-causality AEs	55	20	15	32
Number of participants with treatment-related AEs	51	19	15	31
Number of participants with all-causality SAEs	16	2	6	11
Number of participants with treatment-related SAEs	11	0	6	9

Population analysed: 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).

Primary outcome: 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)

Time frame: Baseline up to 6 months after EOT (52 months in maximum). Count of participants. Unit: Participants

Measure	Cohort All mCRPC Patients n = 56	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n = 20	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n = 15	Cohort 7A and 3B Combined n = 32
Grade 3 or Grade 4 (all-causality)	33	10	11	21
Grade 3 or Grade 4 (treatment-related)	23	6	10	17
Grade 5 (all-causality)	4	0	1	3
Grade 5 (treatment-related)	1	0	1	0

Primary outcome: Number of Participants With AEs Leading to Discontinuation or Dose Reduction

Time frame: Baseline up to 6 months after EOT (52 months in maximum). Count of participants. Unit: Participants

Measure	Cohort All mCRPC Patients n = 56	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n = 20	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n = 15	Cohort 7A and 3B Combined n = 32
Number of participants with permanent discontinuations	16	1	10	11
Number of participants with temporary discontinuations	17	5	5	9
Number of participants with dose reductions	0	1	0	0

Population analysed: 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).

Primary outcome: Number of Participants With Dose-Limiting Toxicities (DLTs)

Time frame: The first 28 days following the first AdC68 vaccination (on Cycle 1 Day 1). Count of participants. Unit: Participants

Measure	Cohort All mCRPC Patients n = 54	Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg n = 20	Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg n = 15	Cohort 7A and 3B Combined n = 32
Value	1	0	0	0

Population analysed: 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).

37 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 6 months after EOT (52 months in maximum). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1A: AdC68 4x10^11 VP + pDNA 5 mg	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Cohort 2A: AdC68 6x10^11 VP + pDNA 5 mg	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Cohort 3A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg	2 of 6 (33.3%)	5 of 6 (83.3%)	0 of 6
Cohort 6A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg	2 of 8 (25%)	8 of 8 (100%)	1 of 8
Cohort 7A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg	4 of 14 (28.6%)	14 of 14 (100%)	2 of 14
Cohort 9A: AdC68 6x10^11 VP + pDNA 5 mg + Treme 40 mg + PF-06801591 130 mg	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Cohort 1B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg	2 of 20 (10%)	20 of 20 (100%)	0 of 20
Cohort 3B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 300 mg	7 of 18 (38.9%)	18 of 18 (100%)	2 of 18
Cohort 5B: AdC68 6x10^11 VP + pDNA 5 mg + Treme 80 mg + PF-06801591 130 mg	6 of 15 (40%)	15 of 15 (100%)	1 of 15

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36948505Autio KA, Higano CS, Nordquist L, Appleman LJ, Zhang T, Zhu XH, Babiker H, Vogelzang NJ, Prasad SM, Schweizer MT, Madan RA, Billotte S, Cavazos N, Bogg O, Li R, Chan K, Cho H, Kaneda M, Wang IM, Zheng J, Tang SY, Hollingsworth R, Kern KA, Petrylak DP. First-in-human, phase 1 study of PF-06753512, a vaccine-based immunotherapy regimen (VBIR), in non-metastatic hormone-sensitive biochemical recurrence and metastatic castration-resistant prostate cancer (mCRPC). J Immunother Cancer. 2023 Mar;11(3):e005702. doi: 10.1136/jitc-2022-005702.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-06755992, PF-06755990 and TDS-IM Electroporation Device in people with Prostatic Neoplasms, run by Pfizer at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to 6 months after End of Treatment (EOT; 52 months in maximum)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02616185, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.