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

Study Description

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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; Drug: Sunitinib; Biological: PF-06801591	Phase 1

Study Design

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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

Arms and Interventions

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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.

Outcome Measures

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Primary Outcome Measures :

1. 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 :

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; Day 29 of Cycle 2; every 4 months thereafter for up to 3 years ]
8. 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 ]
9. 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 ]
10. 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 ]
11. 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 ]
12. 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 ]
13. 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 ]
14. 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 ]
15. 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 ]

Eligibility Criteria

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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

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

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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	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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Additional Information:

To obtain contact information for a study center near you, click here. 

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
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