Loading clinical trials...

Pembro and HER2Bi-Armed Activated T Cells in Treating Patients With Metastatic Castration Resistant Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT03406858•Barbara Ann Karmanos Cancer Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Be willing and able to provide written informed consent/assent for the trial
•Have histologically confirmed prostate adenocarcinoma, with metastases
•Progression by either PSA, Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria for measurable disease or new areas of metastases on bone scan or symptom progression related to prostate cancer despite castrate levels of testosterone; (level \< 50 ng/ml)
•Be agreeable to continue to maintain castrate levels of testosterone
•At least 2 weeks should have elapsed since any immunosuppressive therapy
•At least 4 weeks since prior chemotherapy for metastatic disease or at least 2 weeks since prior androgen targeting agents such as ketoconazole, abiraterone, enzalutamide, etc.
•Discontinue anti-androgens prior to therapy; at least 6 weeks since last dose of bicalutamide or nilutamide and at least 4 weeks from last dose of flutamide
•Have normal bone marrow, renal and hepatic function as deemed by the treating physician and approved by the clinical principal investigator (PI) Dr. Vaishampayan
•Not have concurrent anti-cancer therapy
•Not have concurrent immunosuppressive therapy or medical condition likely to cause immunosuppression
+13 more criteria

Exclusion Criteria

•Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
•Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (\> 10 mg of prednisone daily or equivalent steroid doses) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
•Has a known history of active TB (Bacillus tuberculosis)
•Has hypersensitivity to pembrolizumab or any of its excipients
•Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or has not recovered (i.e. =\< grade 1 or at baseline) from adverse events due to agents administered earlier; Note: Subjects with =\<grade 2 neuropathy are an exception to this criterion and may qualify for the study
•Has received major surgery, subject must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
•Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
•Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment; this exception does not include carcinomatous meningitis which is excluded regardless of clinical stability
•Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
•Has known history of, or any evidence of active, non-infectious pneumonitis
+9 more criteria

Locations (1)

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Key Dates

Start Date

June 7, 2018

Primary Completion Date

January 20, 2021

Completion Date

November 7, 2022

Last Updated

May 3, 2023

Enrollment

ACTUAL participants

Conditions

Castration Levels of TestosteroneCastration-Resistant Prostate CarcinomaProstate Carcinoma Metastatic in the BonePSA ProgressionStage IV Prostate Adenocarcinoma AJCC v7

Interventions

HER2Bi-Armed Activated T Cells

BIOLOGICAL

Laboratory Biomarker Analysis

OTHER

Pembrolizumab

BIOLOGICAL

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

View study

RECRUITINGPHASE1

Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer

NCT06305598

Castration-Resistant Prostate CarcinomaMetastatic Prostate Carcinoma+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer

Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer

Testing Whether the Addition of Carboplatin Chemotherapy to Cabazitaxel Chemotherapy Will Improve Outcomes Compared to Cabazitaxel Alone in People With Castrate-Resistant Prostate Cancer That Has Spread Beyond the Prostate to Other Parts of the Body

Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer

Testing Two Oral Drugs Combination (Cediranib and Olaparib) Compared to a Single Drug (Olaparib) for Men With Advanced Prostate Cancer