CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 14 enrolled
Drug / intervention
Enzyme Inhibitor Therapy +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03229278
NCT03229278Phase 1Completed
CompareCT.gov

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

Rutgers, The State University of New Jersey·interventional·Posted Jul 25, 2017·Updated Dec 6, 2023

In Brief

A Phase 1 clinical trial evaluating Enzyme Inhibitor Therapy, Laboratory Biomarker Analysis, and 2 other interventions for Lymphoma and 28 related conditions. Completed, enrolled 14 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, 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
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJul 25, 2017
Enrollment StartOct 3, 2017
Primary CompletionOct 20, 2022
Study CompletionOct 30, 2022
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 8.9 years ago

Interventions

Enzyme Inhibitor Therapydrug

Given trigriluzole PO

Laboratory Biomarker Analysisother

Correlative studies

Nivolumabbiological

Given IV

Pembrolizumabbiological

Given IV