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Trial record 1 of 1 for:    02616185
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A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)

This study is currently recruiting participants.
Verified October 2017 by Pfizer
Sponsor:
ClinicalTrials.gov Identifier:
NCT02616185
First Posted: November 26, 2015
Last Update Posted: November 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of a vaccine-based immunotherapy regimen for patients with prostate cancer.

Condition Intervention Phase
Prostatic Neoplasms Biological: PF-06755992 Biological: PF-06755990 Device: TDS-IM Electroporation Device Biological: Tremelimumab Drug: Sunitinib Biological: PF-06801591 Phase 1

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence and grade of treatment-emergent adverse events including DLTs [ Time Frame: Baseline up to Day 29 ]
    DLTs in order to determine the maximum tolerated dose


Secondary Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Incidence and titers of anti-drug antibodies against tremelimumab [ Time Frame: Day 1, Day 29, and Day 85 of Cycle 1; Day 29 of Cycle 2; every 4 months thereafter for up to 3 years ]
  • Maximum observed plasma concentration of sunitinib (Cmax) [ Time Frame: Day -15, Day -1 at 0 hour, 2, 4 and any time between 6 to 12 hours after sunitinib dosing; Day 1 and Day 29 of Cycle 1; Day 29 of Cycle 2 and subsequent cycles up to 3 years ]
  • Time to maximum concentration of sunitinib (Tmax) [ Time Frame: Day -15, Day -1 at 0 hour, 2, 4 and any time between 6 to 12 hours after sunitinib dosing; Day 1 and Day 29 of Cycle 1; Day 29 of Cycle 2 and subsequent cycles up to 3 years ]
  • Steady state area under the curve during one dose interval of sunitinib (AUCtau) [ Time Frame: Day -15, Day -1 at 0 hour, 2, 4 and any time between 6 to 12 hours after sunitinib dosing; Day 1 and Day 29 of Cycle 1; Day 29 of Cycle 2 and subsequent cycles up to 3 years ]
  • Incidence and titers of neutralizing antibodies against PF-06801591 [ Time Frame: Day 1, Day 29 and Day 85 of Cycle 1; Day 29 of Cycle 2; every 4 months thereafter for up to 3 years ]
  • 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; pre-dose on Day 1 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years ]
  • 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; pre-dose on Day 1 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years ]
  • 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; pre-dose on Day 1 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years ]
  • 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; pre-dose on Day 1 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years ]

Estimated Enrollment: 133
Actual Study Start Date: December 30, 2015
Estimated Study Completion Date: September 11, 2021
Estimated Primary Completion Date: September 20, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Escalation 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  • 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
  Contacts and Locations
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


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
United States, Connecticut
Smilow Cancer Hospital at Yale-New Haven Recruiting
New Haven, Connecticut, United States, 06510
United States, Maryland
National Institutes of Health Recruiting
Bethesda, Maryland, United States, 20892-1196
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
United States, Michigan
Karmanos Cancer Institute Not yet recruiting
Detroit, Michigan, United States, 48201
United States, Nebraska
GU Research Network Active, not recruiting
Omaha, Nebraska, United States, 68130
United States, Nevada
Comprehensive Cancer Centers of Nevada Active, not recruiting
Las Vegas, Nevada, United States, 89169
United States, New York
Memorial Sloan-Kettering Cancer Center 53rd Street Recruiting
New York, New York, United States, 10022
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Memorial Sloan-Kettering Cancer Center, Sidney Kimmel Center Recruiting
New York, New York, United States, 10065
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Investigational Chemotherapy Services Recruiting
Durham, North Carolina, United States, 27710
United States, Pennsylvania
UPMC Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
UPMC CancerCenter- Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Washington
Seattle Cancer Care Alliance Active, not recruiting
Seattle, Washington, United States, 98109
University of Washington Medical Center Active, not recruiting
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02616185     History of Changes
Other Study ID Numbers: B7791001
PRCA VBIR FIP STUDY ( Other Identifier: Alias Study Number )
First Submitted: November 24, 2015
First Posted: November 26, 2015
Last Update Posted: November 2, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sunitinib
Tremelimumab
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors