pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03600350|
Recruitment Status : Active, not recruiting
First Posted : July 26, 2018
Last Update Posted : February 8, 2022
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: pTVG-HP Drug: Nivolumab Drug: GM-CSF||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single-arm, single-institution, two-stage phase II trial|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) and Nivolumab in Patients With Non-Metastatic, PSA-Recurrent Prostate Cancer|
|Actual Study Start Date :||September 10, 2018|
|Estimated Primary Completion Date :||October 31, 2022|
|Estimated Study Completion Date :||October 31, 2023|
Experimental: Treatment Group
Plasmid DNA vaccine encoding Prostatic Acid Phosphatase (PAP)
Nivolumab is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with multiple different types of cancer.
Other Name: Opdivo
Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a growth factor that supports the survival, clonal expansion and differentiation of hematopoietic progenitor cells including dendritic antigen presenting cells.
- Percentage of subjects within acceptable toxicity boundaries [ Time Frame: up to 48 weeks ]Subjects will be evaluated at each visit by a review of systems based on the most recent version of the NCI common toxicity criteria. Safety and Tolerability of this intervention is defined as following: a toxicity rate p0 of at most 15% of Grade ≥ 3 toxicity events (CTCAE v.4.0) will be considered as acceptable while a toxicity rate p1=35% or more will be considered as unacceptably high. Percentage of subjects within acceptable toxicity boundaries will be reported (95% confidence intervals constructed using the Wilson score method).
- Prostate-Specific Antigen (PSA) Complete Response (CR) Rate [ Time Frame: up to 48 weeks ]A PSA CR will be defined as the percentage of participants with a serum PSA <0.2 ng/mL and confirmatory PSA <0.2 ng/mL at least 4 weeks later, as per Prostate Cancer Working Group 2 (PCWG2) recommendations. To qualify as a PSA CR, there must be no evidence of radiographic progression.
- Metastasis-free Survival Rate [ Time Frame: Up to 2 years ]The 2-year metastasis-free survival will be determined by investigator review of radiographic studies (CT/MRI and bone scintigraphy) performed 2 years after study initiation in subjects who have not already met criteria for radiographic progression.
- Median Radiographic Progression-free Survival [ Time Frame: Up to 2 years ]All participants will undergo radiographic imaging prior to treatment and at 6-month intervals (or as clinically required). The appearance of lesions consistent with metastatic disease will be used to define radiographic progression.
- PSA Doubling Time [ Time Frame: Up to 2 years ]Post-treatment doubling time will be calculated from: 1) All PSA values obtained from the same clinical laboratory using the same PSA assay beginning with the PSA value at day 1 (week 0) and continuing until the end-of study (or month 24) value (PSADT 0-24). 2) All PSA values obtained from the same clinical laboratory using the same PSA assay beginning with the PSA value at day 85 (month 3) to the day 253 (month 9) value (PSADT 3-9).
- PSA Response Rate (</= 50% of baseline) [ Time Frame: Up to 2 years ]The percentage of participants with PSA values less than or equal to their baseline value after 2 year.
- Number of participants requiring GM-CSF as an adjuvant after week 4 [ Time Frame: up to week 4 ]GM-CSF is used as a adjuvant if the PSA at week 4 is higher than baseline.
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): NCT03600350
|United States, Wisconsin|
|University of Wisconsin Carbone Cancer Center|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator:||Hamid Emamekhoo||University of Wisconsin, Madison|