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

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ClinicalTrials.gov Identifier: NCT02616185
Recruitment Status : Active, not recruiting
First Posted : November 26, 2015
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Biological: PF-06755992 Biological: PF-06755990 Device: TDS-IM Electroporation Device Biological: Tremelimumab Biological: PF-06801591 Biological: PF-06753512 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: N/A
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 30, 2015
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Dose Escalation
PF-06753512
Biological: PF-06755992
PF-06755992 will be administered on Day 1 of Cycles 1 and 2.
Other Name: AdC68

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

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

Biological: Tremelimumab
PF-06753388 will be administered every 28 days.
Other Name: PF-06753388

Biological: PF-06801591
PF-06801591 will be administered every 28 days.

Biological: PF-06753512
Combination of adenovirus (AdC68) + plasmid DNA (pDNA) + tremelimumab
Other Name: VBIR-1 or PrCa VBIR




Primary Outcome Measures :
  1. Part A. Incidence and grade of treatment-emergent adverse events including DLTs [ Time Frame: Baseline for up to 3 years ]
    DLTs in order to determine the maximum tolerated dose and safety beyond DLT assessment period


Secondary Outcome Measures :
  1. Immune response to the selected prostate cancer tumor-antigens [ Time Frame: Baseline up to Cycle 1 Day 85; Day 1, Day 29 and Day 99 of Cycle 2; every 6 months thereafter up to 3 years ]
  2. Antibody response specific to the PSMA antigen [ Time Frame: Baseline up to Cycle 1 Day 85; Day 1 and Day 99 of Cycle 2; every 4 months thereafter for up to 3 years ]
  3. Maximum observed plasma concentration of tremelimumab (Cmax) [ Time Frame: Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57 and Day 85 of Cycle 1; pre-dose on Day 2 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years ]
  4. Time to maximum concentration of tremelimumab (Tmax) [ Time Frame: Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57 and Day 85 of Cycle 1; pre-dose on Day 2 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years ]
  5. Area under the curve from time zero extrapolated to infinity of tremelimumab [ Time Frame: Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57 and Day 85 of Cycle 1; pre-dose on Day 2 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years ]
  6. Trough concentrations after multiple doses of tremelimumab (Ctrough) [ Time Frame: Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57 and Day 85 of Cycle 1; pre-dose on Day 2 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years ]
  7. Incidence and titers of anti-drug antibodies against tremelimumab [ Time Frame: Day 1, Day 29, and Day 85 of Cycle 1 (each Cycle is 16 weeks); Day 29 of Cycle 2; every 4 months thereafter for up to 3 years ]
  8. Incidence and titers of neutralizing antibodies against PF-06801591 [ Time Frame: Day 1, Day 29 and Day 85 of Cycle 1 (each Cycle is 16 weeks); Day 29 of Cycle 2; every 4 months thereafter for up to 3 years ]
  9. Maximum observed plasma concentration of PF-06801591 (Cmax) [ Time Frame: Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each Cycle is 16 weeks); pre-dose on Day 1 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years ]
  10. Time to maximum concentration of PF-06801591 (Tmax) [ Time Frame: Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each Cycle is 16 weeks); pre-dose on Day 1 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years ]
  11. Area under the curve from time zero extrapolated to infinity of PF-06801591 [ Time Frame: Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each Cycle is 16 weeks); pre-dose on Day 1 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years ]
  12. Trough concentrations after multiple doses of PF-06801591 (Ctrough) [ Time Frame: Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each Cycle is 16 weeks); pre-dose on Day 1 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02616185


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02616185    
Other Study ID Numbers: B7791001
PRCA VBIR FIP STUDY ( Other Identifier: Alias Study Number )
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Tremelimumab
Antineoplastic Agents