Pembrolizumab and HER2Bi-Armed Activated T Cells in Treating Patients With Metastatic Castration Resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03406858|
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : September 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Castration Levels of Testosterone Castration-Resistant Prostate Carcinoma Prostate Carcinoma Metastatic in the Bone PSA Progression Stage IV Prostate Adenocarcinoma AJCC v7||Biological: HER2Bi-Armed Activated T Cells Other: Laboratory Biomarker Analysis Biological: Pembrolizumab||Phase 2|
I. To estimate the clinical efficacy of 8 infusions of HER2 HER2Bi-armed activated T cells (BATs) (up to 10^10/infusion) twice per week for 4 weeks in combination with pembrolizumab once every 3 weeks starting with one dose 3 weeks before the 1st BATs infusion, by assessing the percentage of patients free of clinical progression at 6 months after registration.
I. Evaluate phenotype, cytokine profiles and IFN-gamma enzyme-linked immunosorbent spots (ELISpots), cytotoxicity and antibodies directed at laboratory prostate cancer cell lines for proof of principle of immune system activation and to correlate with clinical outcomes of response, progression free survival (PFS), and overall survival (OS).
II. Evaluate the magnitude of change in tumor infiltrating T cells, PD-1 expression, and the Th1/Th2 ratio in prostate cancer tumor tissue before and after immunotherapy and correlate it with the clinical outcomes of response, PFS, and OS.
Patients receive pembrolizumab intravenously (IV) over 30 minutes every 3 weeks. Treatment repeats every 3 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity. Beginning at least 1 week after pembrolizumab, patients receive HER2Bi-armed activated T cells IV over 5-15 minutes 2 times a week for 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Immune Checkpoint Inhibitor With Anti-CD3 x Anti-HER2 Bispecific Antibody Armed Activated T Cells in Metastatic Castrate Resistant Prostate Cancer|
|Actual Study Start Date :||June 7, 2018|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 1, 2019|
Experimental: Treatment (pembrolizumab, HER2Bi-armed activated T cells)
Patients receive pembrolizumab IV over 30 minutes every 3 weeks. Treatment repeats every 3 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity. Beginning at least 1 week after pembrolizumab, patients receive HER2Bi-armed activated T cells IV over 5-15 minutes 2 times a week for 4 weeks in the absence of disease progression or unacceptable toxicity.
Biological: HER2Bi-Armed Activated T Cells
Other: Laboratory Biomarker Analysis
- Progression-free survival [ Time Frame: Up to 6 months ]
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): NCT03406858
|United States, Michigan|
|Wayne State University/Karmanos Cancer Institute||Recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: Ulka N. Vaishampayan 313-576-8715 email@example.com|
|Principal Investigator: Ulka N. Vaishampayan, M.D.|
|Sub-Investigator: Abhinav Deol, M.D.|
|Sub-Investigator: Elisabeth I. Heath, M.D.|
|Sub-Investigator: Joseph Fontana, M.D.|
|Sub-Investigator: Wael Sakr, M.D.|
|Sub-Investigator: Dongping Shi|
|Principal Investigator:||Ulka Vaishampayan||Barbara Ann Karmanos Cancer Institute|