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

Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT02616185
Collaborator
(none)
91
Enrollment
19
Locations
1
Arm
61.8
Actual Duration (Months)
4.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Biological: PF-06755992
  • Biological: PF-06755990
  • Device: TDS-IM Electroporation Device
  • Biological: Tremelimumab
  • Biological: PF-06801591
  • Biological: PF-06753512
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
91 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 :
Dec 30, 2015
Actual Primary Completion Date :
Feb 23, 2021
Actual Study Completion Date :
Feb 23, 2021

Arms and Interventions

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 Names:
  • AdC68

    • Biological: PF-06755990
    PF-06755990 will be administered using a device on Day 29, 57 and 85 of each cycle.
    Other Names:
  • 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 Names:
  • 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 Names:
  • VBIR-1 or PrCa VBIR

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Part A. Incidence and grade of treatment-emergent adverse events including DLTs [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 [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 [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) [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) [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 [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) [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 [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 [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) [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) [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 [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) [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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner-University Medical Center Tucson Tucson Arizona United States 85719
    2 The University of Arizona Cancer Center-North Campus Tucson Arizona United States 85719
    3 Smilow Cancer Hospital at Yale-New Haven New Haven Connecticut United States 06510
    4 Smilow Cancer Hospital Phase 1 Unit New Haven Connecticut United States 06511
    5 National Institutes of Health Clinical Center Bethesda Maryland United States 20892
    6 GU Research Network Omaha Nebraska United States 68130
    7 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89169
    8 Garden State Urology Morristown New Jersey United States 07960
    9 Morristown Medical Center Morristown New Jersey United States 07960
    10 Garden State Urology Rockaway New Jersey United States 07866
    11 Garden State Urology Whippany New Jersey United States 07981
    12 Northwell Health Lake Success New York United States 11042
    13 Memorial Sloan-Kettering Cancer Center 53rd Street New York New York United States 10022
    14 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    15 Memorial Sloan-Kettering Cancer Center, Sidney Kimmel Center New York New York United States 10065
    16 Duke University Medical Center Durham North Carolina United States 27710
    17 UPMC Hillman Cancer Center Pittsburgh Pennsylvania United States 15232
    18 Seattle Cancer Care Alliance Seattle Washington United States 98109
    19 University of Washington Medical Center Seattle Washington United States 98195

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT02616185
    Other Study ID Numbers:
    • B7791001
    • PRCA VBIR FIP STUDY
    First Posted:
    Nov 26, 2015
    Last Update Posted:
    Dec 17, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Tremelimumab

    Study Results

    No Results Posted as of Dec 17, 2021