NCT03050060

Image Guided Hypofractionated Radiation Therapy, Nelfinavir Mesylate, Pembrolizumab, Nivolumab and Atezolizumab in Treating Patients With Advanced Melanoma, Lung, or Kidney Cancer

ImmunoRad: Stratified Phase II Trial of Image Guided Hypofractionated Radiotherapy With Concurrent Nelfinavir and Immunotherapy in Advanced Melanoma, Lung Cancer, and Renal Cell Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well image guided hypofractionated radiation therapy works with nelfinavir mesylate, pembrolizumab, nivolumab, and atezolizumab in treating patients with melanoma, lung cancer, or kidney cancer that has spread (advanced). Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Nelfinavir mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, nivolumab and atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving hypofractionated radiation therapy, nelfinavir mesylate, pembrolizumab, nivolumab and atezolizumab may work better in treating patients with melanoma, lung, or kidney cancer.

Detailed description

OUTLINE: Beginning 7-14 days prior to start of pembrolizumab, nivolumab, or atezolizumab, patients receive nelfinavir mesylate orally (PO) twice daily (BID) on days 1-7 or 1-14 (dependent upon when treatment is started) up to 11-12 weeks. Patients also receive pembrolizumab, nivolumab or atezolizumab intravenously (IV) over 30-60 minutes on day 1. Cycles repeat every 21-28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo hypofractionated radiation therapy over 3-14 days starting after cycle 1 and before cycle 3 of pembrolizumab, nivolumab or atezolizumab. After completion of study treatment, patients are followed up at 30 days and then every 6 months for up to 2 years.

Conditions

• Metastatic Kidney Carcinoma
• Recurrent Lung Non-Small Cell Carcinoma
• Stage IV Cutaneous Melanoma AJCC v6 and v7
• Stage IV Renal Cell Cancer AJCC v7
• Stage IV Lung Non-Small Cell Cancer AJCC v7

Interventions

Type	Name	Description
DRUG	Atezolizumab	Given IV
RADIATION	Hypofractionated Radiation Therapy	Undergo hypofractionated radiation therapy
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Nelfinavir Mesylate	Given PO
BIOLOGICAL	Nivolumab	Given IV
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2017-06-09
• Primary completion: 2018-10-01
• Completion: 2020-07-12
• First posted: 2017-02-10
• Last updated: 2022-06-22
• Results posted: 2022-06-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study