A Phase II Study of Several Radiation Doses Added to Immunotherapy in Patients Whose Cancers Grew While Receiving Immunotherapy

Full Title

A Phase II Trial of Hypofractionated Radiotherapy in Patients with Limited Progression on Immune Checkpoint Blockade

Purpose

“Checkpoint inhibitors” work by taking the brakes off proteins that prevent the immune system from attacking cancer cells. Examples of checkpoint inhibitors include ipilimumab, nivolumab, avelumab, durvalumab, pembrolizumab, atezolizumab, and tremelimumab. It is not uncommon for patients’ cancers to continue to grow while receiving these drugs.

In this study, researchers want to see if adding a form of radiation therapy called stereotactic body radiation therapy (SBRT) to checkpoint inhibitor immunotherapy can jump start the immune response against metastatic cancer. SBRT is a commonly used type of radiation therapy that delivers high-dose radiation with high precision to tumors (including metastatic cancer sites) over one to five treatments. Patients will continue to receive their immunotherapy during this study while they receive SBRT.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic cancer that started to grow while receiving checkpoint inhibitor immunotherapy. Examples including lung, bladder, liver, kidney, or head and neck cancer and melanoma.
  • At least 2 weeks must pass between the completion of any treatments other than immunotherapy and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Yoshiya (Josh) Yamada at 212-639-2950.

Protocol

18-359

Phase

II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator