NCT03229278

Trigriluzole With Nivolumab and Pembrolizumab in Treating Patients With Metastatic or Unresectable Solid Malignancies or Lymphoma

A Phase I Study to Evaluate the Safety of Trigriluzole (FC-4157/BHV-4157) in Combination With PD-1 Blocking Antibodies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the best dose and side effects of trigriluzole in combination with nivolumab and pembrolizumab in treating patients with solid malignancies or lymphoma that has spread to other places in the body or cannot be removed by surgery. Trigriluzole may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as nivolumab and pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving trigriluzole in combination with nivolumab and pembrolizumab may work better at treating patients with solid malignancies or lymphoma.

Detailed description

PRIMARY OBJECTIVES: I. The primary objective of this study is to determine the safety of trigriluzole in combination with PD-1 inhibiting antibodies, and to define a maximum tolerated dose (MTD) of trigriluzole in combination therapy. SECONDARY OBJECTIVES: I. To characterize the efficacy of the combination therapy. II. To identify markers of response to trigriluzole in the tumor microenvironment. OUTLINE: This is a dose-escalation study of trigriluzole. Patients receive trigriluzole orally (PO) every other day (QOD), twice daily (BID), every morning (QAM) or every bedtime (QHS) on days -14 to -1. Patients then receive nivolumab intravenously (IV) over 60 minutes every 2 weeks beginning week 1 and trigriluzole PO QOD, BID, QAM or QHS. Once the MTD of trigriluzole with nivolumab is identified, patients receive pembrolizumab IV over 30 minutes every 3 weeks beginning week 1 and trigriluzole PO. Treatment repeats for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 12 weeks for up to 3 years.

Conditions

• Lymphoma
• Metastatic Malignant Solid Neoplasm
• Metastatic Melanoma
• Metastatic Renal Cell Cancer
• Recurrent Bladder Carcinoma
• Recurrent Classical Hodgkin Lymphoma
• Recurrent Head and Neck Squamous Cell Carcinoma
• Recurrent Lymphoma
• Recurrent Malignant Solid Neoplasm
• Recurrent Renal Cell Carcinoma
• Stage III Bladder Cancer
• Stage III Lymphoma
• Stage III Non-Small Cell Lung Cancer AJCC v7
• Stage III Renal Cell Cancer
• Stage III Skin Melanoma
• Stage IIIA Non-Small Cell Lung Cancer AJCC v7
• Stage IIIA Skin Melanoma
• Stage IIIB Non-Small Cell Lung Cancer AJCC v7
• Stage IIIB Skin Melanoma
• Stage IIIC Skin Melanoma
• Stage IV Bladder Cancer
• Stage IV Lymphoma
• Stage IV Non-Small Cell Lung Cancer AJCC v7
• Stage IV Renal Cell Cancer
• Stage IV Skin Melanoma
• Stage IVA Bladder Cancer
• Stage IVB Bladder Cancer
• Unresectable Head and Neck Squamous Cell Carcinoma
• Unresectable Solid Neoplasm

Interventions

Type	Name	Description
DRUG	Enzyme Inhibitor Therapy	Given trigriluzole PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Nivolumab	Given IV
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2017-10-03
• Primary completion: 2022-10-20
• Completion: 2022-10-30
• First posted: 2017-07-25
• Last updated: 2023-12-06
• Results posted: 2023-12-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study