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Trial record 1 of 1 for:
02616185
A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)
This study has suspended participant recruitment.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02616185
First received: November 24, 2015
Last updated: June 16, 2017
Last verified: June 2017
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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: No masking 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:
Genetics Home Reference related topics:
prostate cancer
MedlinePlus related topics:
Prostate Cancer
U.S. FDA Resources
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 and then every 29 and 99 days thereafter up to 3 years ]
- Antibody response specific to the PSMA antigen [ Time Frame: Baseline up to Cycle 1 Day 85 and then every 29 and 99 days thereafter up to 3 years ]
- Maximum observed plasma concentration of tremelimumab (Cmax) [ Time Frame: Pre-dose on Day 1, Day 29, Day 85 of Cycle 1; pre-dose on Day 29 of Cycle 2 and subsequent cycle up to 3 years ]
- Time to maximum concentration of tremelimumab (Tmax) [ Time Frame: Pre-dose on Day 1, Day 29, Day 85 of Cycle 1; pre-dose on Day 29 of Cycle 2 and subsequent cycle up to 3 years ]
- Area under the curve from time zero extrapolated to infinity of tremelimumab [ Time Frame: Pre-dose on Day 1, Day 29, Day 85 of Cycle 1; pre-dose on Day 29 of Cycle 2 and subsequent cycle up to 3 years ]
- Trough concentrations after multiple doses of tremelimumab (Ctrough) [ Time Frame: Pre-dose on Day 1, Day 29, Day 85 of Cycle 1; pre-dose on Day 29 of Cycle 2 and subsequent cycle up to 3 years ]
- Incidence and titers of anti-drug antibodies against tremelimumab [ Time Frame: From baseline up to Cycle 1 Day 85 and then on Day 1 and Day 29 of each cycle thereafter 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: From baseline up to Cycle 1 Day 85 and then on Day 1 and Day 29 of each cycle thereafter up to 3 years ]
- Maximum observed plasma concentration of PF-06801591 (Cmax) [ Time Frame: Pre-dose on Day 1, Day 29, Day 85 of Cycle 1; pre-dose on Day 29 of Cycle 2 and subsequent cycle up to 3 years ]
- Time to maximum concentration of PF-06801591 (Tmax) [ Time Frame: Pre-dose on Day 1, Day 29, Day 85 of Cycle 1; pre-dose on Day 29 of Cycle 2 and subsequent cycle 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 29, Day 85 of Cycle 1; pre-dose on Day 29 of Cycle 2 and subsequent cycle up to 3 years ]
- Trough concentrations after multiple doses of PF-06801591 (Ctrough) [ Time Frame: Pre-dose on Day 1, Day 29, Day 85 of Cycle 1; pre-dose on Day 29 of Cycle 2 and subsequent cycle up to 3 years ]
| Estimated Enrollment: | 133 |
| Actual Study Start Date: | December 30, 2015 |
| Estimated Study Completion Date: | April 20, 2019 |
| Estimated Primary Completion Date: | April 20, 2019 (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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Male |
| 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02616185
Please refer to this study by its ClinicalTrials.gov identifier: NCT02616185
Locations
| United States, Connecticut | |
| Smilow Cancer Hospital at Yale-New Haven | |
| New Haven, Connecticut, United States, 06510 | |
| United States, Maryland | |
| National Institutes of Health | |
| Bethesda, Maryland, United States, 20892-1196 | |
| National Institutes of Health Clinical Center | |
| Bethesda, Maryland, United States, 20892 | |
| United States, Michigan | |
| Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
| United States, Nebraska | |
| GU Research Network | |
| Omaha, Nebraska, United States, 68130 | |
| United States, Nevada | |
| Comprehensive Cancer Centers of Nevada | |
| Las Vegas, Nevada, United States, 89169 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center 53rd Street | |
| New York, New York, United States, 10022 | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| Memorial Sloan-Kettering Cancer Center, Sidney Kimmel Center | |
| New York, New York, United States, 10065 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Investigational Chemotherapy Services | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| Thomas Jefferson University, Sidney Kimmel Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Thomas Jefferson University | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| UPMC Cancer Center | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| UPMC CancerCenter- Hillman Cancer Center | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, Washington | |
| Seattle Cancer Care Alliance | |
| Seattle, Washington, United States, 98109 | |
| University of Washington Medical Center | |
| 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 ) |
| Study First Received: | November 24, 2015 |
| Last Updated: | June 16, 2017 |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Tremelimumab |
Sunitinib Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on June 23, 2017