Investigation of the Timely-coordinated Therapy of Patients With Metastatic Cancer by Radiotherapy Together With Immune Checkpoint Inhibition

Sponsor
University of Erlangen-Nürnberg Medical School
Study ID
NCT03453892
Status
Completed

Conditions

  • Metastatic Cancer

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    The normal clinical treatment-plan of the underlying disease remains unchanged.
  • Pembrolizumab — DRUG
    The normal clinical treatment-plan of the underlying disease remains unchanged.
  • Radiotherapy — RADIATION
    The normal clinical treatment-plan of the underlying disease remains unchanged.
  • Ipilimumab — DRUG
    The normal clinical treatment-plan of the underlying disease remains unchanged.

Study Details

Immunotherapy for the treatment of several cancer entities steadily increased during the last years. The data from the finalized and ongoing studies show the tremendous impact of immune checkpoint inhibition (ICI) also for advanced metastatic patients. Especially the ICI with pembrolizumab and nivolumab have an increasing number of first line treatment approvals. However, in particular metastatic patients which receive ICI therapy are often irradiated for immediate palliation of several metastases. Preclinical work revealed that radiotherapy (RT) is capable to modulate the tumor phenotype, its microenvironment in a way that systemic anti-tumor immune responses are induced. However, radiation has also immune suppressive properties as e.g. the expression of immune checkpoint molecules is increased following radiotherapy. So the ICI therapy in combination with the RT has the potential to overcome the immunotolerance of the tumor and the metastases. More and more reports therefore describe a so-called systemic immune-modulating effect of radiotherapy (former and still often named as abscopal effect). However the timely application of ICI and RT is often randomly and depends on the clinical need for the palliative RT. The aim of this trial is therefore to standardize the chronology of RT in combination with ICI, to evaluate the effects of radio-immunotherapy with a stratified and comparable patient cohort. The ST-ICI study is a prospective and observational study not influencing the standard therapeutic scheme and will provide hints how the radio-immune therapy drives systemic anti tumor responses.

Key Dates

Start date
Apr 1, 2017
Status verified
Feb 2023
Primary completion
Feb 28, 2021
Completion
Dec 30, 2022

Study Design

Enrollment
150 participants (actual)

Arms

  • Arm: anti CTLA-4
    The study cohort consist of patients suffering from metastatic cancer of several entities which will be treated with palliative RT and/or ICI (anti CTLA-4) at Department of Radiation Oncology of Universitätsklinikum Erlangen.
  • Arm: anti PD-1/PD-L1
    The study cohort consist of patients suffering from metastatic cancer of several entities which will be treated with palliative RT and/or ICI (anti PD-1/PD-L1) at Department of Radiation Oncology of Universitätsklinikum Erlangen.

Primary Outcome Measure

Systemic (according to iRECIST criteria) and local response of detected metastases during radio and/or immunotherapy. [ Time Frame: From date of inclusion to the trial until the date of first documented iRECIST progression or date of death from any cause, whichever came first, assessed up to day 540. ]

Related Studies