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
:
Recruiting
First Posted
: November 26, 2015
Last Update Posted
: April 11, 2018
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Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
Estimated Enrollment : | 133 participants |
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 2015 |
Estimated Primary Completion Date : | September 2020 |
Estimated Study Completion Date : | March 2021 |

Arm | Intervention/treatment |
---|---|
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.
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- 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
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Gender Based Eligibility: | Yes |
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
- 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

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
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
United States, Connecticut | |
Smilow Cancer Hospital at Yale-New Haven | Recruiting |
New Haven, Connecticut, United States, 06510 | |
United States, Maryland | |
National Institutes of Health | Active, not recruiting |
Bethesda, Maryland, United States, 20892-1196 | |
National Institutes of Health Clinical Center | Active, not recruiting |
Bethesda, Maryland, United States, 20892 | |
United States, Nebraska | |
GU Research Network | Recruiting |
Omaha, Nebraska, United States, 68130 | |
United States, Nevada | |
Comprehensive Cancer Centers of Nevada | 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 | Recruiting |
Seattle, Washington, United States, 98109 | |
University of Washington Medical Center | Recruiting |
Seattle, Washington, United States, 98195 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
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 Posted: | November 26, 2015 Key Record Dates |
Last Update Posted: | April 11, 2018 |
Last Verified: | April 2018 |
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 |