NCT03177460

Daratumumab or FMS Inhibitor JNJ-40346527 Before Surgery in Treating Patients With High-Risk, Resectable Localized or Locally Advanced Prostate Cancer

A Pilot Presurgical Study of Daratumumab (CD38 Antagonist) or JNJ-40346527 in Men With High-Risk Localized Prostate Cancer Followed by Radical Prostatectomy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects of daratumumab or FMS inhibitor JNJ-40346527 before surgery in treating patients with high-risk prostate cancer that can be removed by surgery and has not spread to other parts of the body or has spread to nearby tissue or lymph nodes. Immunotherapy with monoclonal antibodies, such as daratumumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spreadFMS inhibitor JNJ-40346527 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving daratumumab or FMS inhibitor JNJ-40346527 before surgery may work better in treating patients with prostate cancer.

Detailed description

PRIMARY OBJECTIVES: I. Safety and tolerability of therapy with the study drugs in men with high-risk localized prostate cancer. SECONDARY OBJECTIVES: I. To assess the proportion of patients who achieve pathological complete response (CR) with the study drugs in men with high-risk localized prostate cancer. EXPLORATORY OBJECTIVES: I. To study immunological changes in tumor tissues and peripheral blood in response to the study drugs in men with high-risk localized prostate cancer. OUTLINE: Patients are assigned to 1 of 2 arms. ARM A: Patients receive daratumumab intravenously (IV) over 4-8 hours once weekly for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo radical prostatectomy during week 6. ARM B: Patients receive FMS inhibitor JNJ-40346527 orally (PO) twice daily (BID) for 4-5 weeks in the absence of disease progression or unacceptable toxicity. After a 3 day wash-out period, patients undergo radical prostatectomy. After completion of study treatment, patients are followed up at week 18.

Conditions

• Prostate Adenocarcinoma
• Stage III Prostate Cancer AJCC v8
• Stage IIIA Prostate Cancer AJCC v8
• Stage IIIB Prostate Cancer AJCC v8
• Stage IIIC Prostate Cancer AJCC v8
• Testosterone Greater Than 150 ng/dL

Interventions

Type	Name	Description
BIOLOGICAL	Daratumumab	Given IV
DRUG	FMS Inhibitor JNJ-40346527	Given PO
PROCEDURE	Radical Prostatectomy	Undergo radical prostatectomy

Timeline

• Start date: 2017-06-07
• Primary completion: 2024-01-30
• Completion: 2024-01-30
• First posted: 2017-06-06
• Last updated: 2024-05-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study