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

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT03229278
Phase
PHASE1
Status
Completed

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enzyme Inhibitor Therapy — DRUG
    Given trigriluzole PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given IV
  • Pembrolizumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Oct 3, 2017
Status verified
Nov 2023
Primary completion
Oct 20, 2022
Completion
Oct 30, 2022

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (trigriluzole, nivolumab, pembrolizumab)
    Patients receive trigriluzole PO QOD, BID, QAM or QHS on days -14 to -1. Patients then receive nivolumab 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.

Primary Outcome Measure

Maximum Tolerated Dose (MTD))/Recommended Phase 2 Dose of Trigriluzole [ Time Frame: Four weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-

Find similar trials in New Brunswick, NJ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Rutgers Cancer Institute of New Jersey· New Brunswick, NJ

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