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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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NCT02616185

Last updated on October 10, 2018
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FOR MORE INFORMATION
Study Location
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, 06510 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostatic Neoplasms
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

- Progressive disease post-surgical castration or during androgen suppression therapy
(pre-secondary hormone CRPC) OR

- Failed prior therapy with a secondary hormone (e.g. enzalutamide, abiraterone) with
documented progressive disease (post-secondary hormone CRPC)

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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 pre-secondary hormone patients, no prior or concurrent treatment with a secondary
hormone (e.g. enzalutamide, abiraterone)

- For post-secondary hormone patients, no concurrent treatment with a secondary hormone
(e.g. enzalutamide, abiraterone), no metastasis to the liver or brain

NCT02616185
Pfizer
Recruiting
A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)

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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)
The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of a vaccine-based immunotherapy regimen for patients with prostate cancer.
Not Provided
Interventional
Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
Prostatic Neoplasms
  • Biological: PF-06755992
    PF-06755992 will be administered on Day 1 of each cycle. Two dose levels will be evaluated.
  • Biological: PF-06755990
    PF-06755990 will be administered using a device on Day 29, 57 and 85 of each cycle.
  • 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
  • Drug: Sunitinib
    Sunitinib will be taken daily. Up to three dose levels may be evaluated to determine the MTD when given in combination with the PrCa VBIR.
  • Biological: PF-06801591
    PF-06801591 will be administered every 28 days.
Experimental: Dose Escalation
Interventions:
  • Biological: PF-06755992
  • Biological: PF-06755990
  • Device: TDS-IM Electroporation Device
  • Biological: Tremelimumab
  • Drug: Sunitinib
  • Biological: PF-06801591
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
133
September 11, 2021
September 20, 2020   (Final data collection date for primary outcome measure)

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
  • Progressive disease post-surgical castration or during androgen suppression therapy (pre-secondary hormone CRPC) OR
  • Failed prior therapy with a secondary hormone (e.g. enzalutamide, abiraterone) with documented progressive disease (post-secondary hormone CRPC)

Exclusion Criteria:

  • Cancer-related pain requiring scheduled opioid narcotics for control
  • ECOG performance status greater than or equal to 2
  • Concurrent immunotherapy for prostate cancer
  • History of or active autoimmune disorders or history of inflammatory bowel disorders
  • 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 pre-secondary hormone patients, no prior or concurrent treatment with a secondary hormone (e.g. enzalutamide, abiraterone) and no metastasis to organ systems other than lymph nodes and/or bone
  • For post-secondary hormone patients, no concurrent treatment with a secondary hormone (e.g. enzalutamide, abiraterone), no metastasis to the liver or brain
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_[email protected]
United States
 
 
NCT02616185
B7791001
PRCA VBIR FIP STUDY ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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