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

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.

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

DRUG

Enzyme Inhibitor Therapy

Given trigriluzole PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Nivolumab

Given IV

BIOLOGICAL

Pembrolizumab

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Rutgers, The State University of New Jersey

  lead OTHER

Principal Investigators

• Biren Saraiya · Rutgers Cancer Institute of New Jersey

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-03

Primary Completion

2022-10-20

Completion

2022-10-30

FDA Drug

Yes

Countries

• United States

Study Locations