NCT03406858

Pembro and HER2Bi-Armed Activated T Cells in Treating Patients With Metastatic Castration Resistant Prostate Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well pembrolizumab and HER2Bi-armed activated T cells work in treating patients with castration resistant prostate cancer that has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. HER2Bi-armed activated T cells are made using T cells and may target and kill cancer cells. Giving pembrolizumab and HER2Bi-armed activated T cells may work better in treating patients with castration resistant prostate cancer.

Detailed description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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. OUTLINE: 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.

Conditions

• Castration Levels of Testosterone
• Castration-Resistant Prostate Carcinoma
• Prostate Carcinoma Metastatic in the Bone
• PSA Progression
• Stage IV Prostate Adenocarcinoma AJCC v7

Interventions

Type	Name	Description
BIOLOGICAL	HER2Bi-Armed Activated T Cells	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2018-06-07
• Primary completion: 2021-01-20
• Completion: 2022-11-07
• First posted: 2018-01-23
• Last updated: 2023-05-03
• Results posted: 2022-11-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study