NCT04159896

ESK981 and Nivolumab for the Treatment of Metastatic Castration Resistant Prostate Cancer

Phase II Multi-Center Trial of ESK981 in Combination With Nivolumab in Patients With Metastatic Castrate Resistant Prostate Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects of ESK981 and nivolumab and to see how well they work for the treatment of castration resistant prostate cancer that has spread to other places in the body (metastatic). ESK981 is an investigational drug that targets several important pathways that are believed to play a role in the spread of cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to see if giving ESK981 and nivolumab together works better in treating metastatic castration resistant prostate cancer compared to usual treatments.

Detailed description

PRIMARY OBJECTIVES: I. To determine the prostate specific antigen (PSA) \>= 50% response rate (PSA50) from baseline using the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria to pan-VEGFR/TIE2 tyrosine kinase inhibitor CEP-11981 (ESK981) plus nivolumab in men with metastatic castration resistant prostate cancer (mCRPC) who have progressed on enzalutamide (an oral androgen-receptor inhibitor) and/or abiraterone acetate (an androgen synthesis inhibitor) and chemotherapy (docetaxel and/or cabazitaxel). II. To assess the safety and tolerability of ESK981 plus nivolumab. SECONDARY OBJECTIVES: I. To determine the time to PSA response (TTPR) in patients with mCRPC. II. To determine the duration of PSA response (PRD) in patients with mCRPC. III. To determine PSA progression rates as defined by the PCWG3 criteria. IV. To determine PSA progression free survival (PPFS) as defined by the PCWG3 criteria. CORRELATIVE/EXPLORATORY/TERTIARY OBJECTIVE: I. To assess exploratory biomarkers from blood and tumor biopsies. OUTLINE: Patients receive ESK981 orally (PO) once daily (QD) for 5 consecutive days per week, followed by a 2-day break. Patients also receive nivolumab intravenously (IV) on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 5 years.

Conditions

• Castration Levels of Testosterone
• Castration-Resistant Prostate Carcinoma
• Metastatic Prostate Carcinoma
• Prostate Carcinoma Metastatic in the Bone
• Stage IVB Prostate Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Pan-VEGFR/TIE2 Tyrosine Kinase Inhibitor CEP-11981	Given PO
BIOLOGICAL	Nivolumab	Given IV

Timeline

• Start date: 2019-11-13
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2019-11-12
• Last updated: 2024-07-16
• Results posted: 2024-07-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study