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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT03050060
Phase
PHASE2
Status
Terminated

Conditions

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

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 9, 2017
Status verified
May 2022
Primary completion
Oct 1, 2018
Completion
Jul 12, 2020

Study Design

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

Arms

  • Experimental: Treatment (nelfinavir, immunotherapy, radiation therapy)
    Beginning 7-14 days prior to start of pembrolizumab, nivolumab, or atezolizumab, patients receive nelfinavir mesylate PO 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 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. The study will exclude irradiation of liver metastases as an added precaution.

Primary Outcome Measure

Response Rate [ Time Frame: Up to 6 months after initiating treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109-

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By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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