Last updated on May 2018

CHEckpoint Inhibition in Combination With an Immunoboost of External Body Radiotherapy in Solid Tumors

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: melanoma | head and neck cancer | Renal Cell Carcinoma | Non-Small Cell Lung Cancer | skin cancer | Transitional cell carcinoma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Before patient registration, written informed consent must be given according to ICH/GCP and national/local regulations.
  • Histologically confirmed diagnosis of a solid tumour.
  • At least one tumour lesion available for radiotherapy administration.
  • Patient will receive a checkpoint inhibitor per standard of care in one of the following settings (locally advanced or metastatic): melanoma (1st - 3rd line nivolumab or pembrolizumab); renal cell carcinoma (2nd line nivolumab); non-small cell lung carcinoma (2nd or 3rd line nivolumab or pembrolizumab); urothelial cell carcinoma ( 1st or 2nd line nivolumab or pembrolizumab); head-& neck squamous cell carcinoma (2nd line nivolumab).
  • Karnofsky Performance status > 60
  • Age 18 years or older.

Exclusion Criteria:

  • Prior radiotherapy preventing treatment with SBRT.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or prostate cancer that has undergone potentially curative therapy and with normalized PSA.
  • Uncontrolled central nervous system (CNS) metastases at baseline (controlled = previously-treated CNS metastases (surgery radiotherapy, radiosurgery, or gamma knife) and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants), and/or carcinomatous meningitis.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. History of human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection.
  • Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
  • Patient not likely to comply with the protocol; I.e. uncooperative attitude, inability to return for follow-up visits and unlikely to complete the study.
  • Contraindication for radiotherapy.
  • Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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