Clinical Trial Detail

Clinical Trials

Clinical Trial Detail

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

Complete title: ImmunoRad: Stratified Phase II Trial of Image Guided Hypofractionated Radiotherapy with concurrent Nelfinavir and Immunotherapy in Advanced Melanoma, Lung Cancer, and Renal Cell Carcinoma

Research Study Number 9712
Principal Investigator Ramesh Rengan
Phase II

Research Study Description

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. 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. Monoclonal antibodies, such as pembrolizumab, nivolumab and atezolizumab, 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.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older (Adult, Senior)

Sexes Eligible for Study: All

- Disease eligibility and stage

-- * Histologically confirmed diagnosis of melanoma, non-small cell lung cancer (NSCLC), or renal carcinoma

-- * Previously treated or previously untreated stage IV melanoma, stage IV lung cancer, and metastatic renal cancer by American Joint Committee on Cancer (AJCC) staging criteria

-- * Presence of a lesion that is suitable for hypofractionated radiotherapy

- Subjects must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria independent of the lesion irradiated

- Prior immunotherapy or chemotherapy is allowed as long as > 14 days prior to enrollment

- Eastern Cooperative Oncology Group (ECOG) 0-2

- Acceptable marrow function and hematologic indices for PD1/PDL1 immune checkpoint inhibitor and nelfinavir as per standard of care

- Ability to understand and the willingness to sign a written informed consent document

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- Subjects who have had immunotherapy, chemotherapy, or radiation therapy within 14 days (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier

- Subjects may not be receiving other investigational agents

- Patients with untreated/active brain metastases as documented by magnetic resonance imaging (MRI) within 2 months of study enrollment

- Allergy or intolerance to nelfinavir or selected PD1/PDL1 immune checkpoint inhibitor

- Patients requiring steroids or other immunosuppressive therapy; low-dose or topical steroids are allowable if being used as replacement therapy

- Patients receiving anti-retroviral therapy or other agents that are contra-indicated with nelfinavir due to drug-drug interactions

- Pregnant or lactating patients

- Prior radiation that precludes delivery of hypofractionated radiotherapy

Other exclusion criteria may apply.

Research Study Number 9712
Contact Seattle Cancer Care Alliance Intake Office
Telephone 800-804-8824 / 206-606-1024

Keywords: Kidney Cancer; Lung Cancer; Melanoma; Renal Cancer; Solid Tumors; Neoplasms, Germ Cell and Embryonal; Neuroendocrine Tumor; Lung Carcinoma, Non-Small-Cell (NSCLC); Carcinoma, Bronchogenic; Urogenital Neoplasms; Urologic Neoplasms; Neuroectodermal Tumors; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Immunotherapy; Neoplasms, Respiratory Tract; Neoplasms, Thoracic; Carcinoma, Renal Cell

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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