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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03453892
Recruitment Status : Active, not recruiting
First Posted : March 5, 2018
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Metastatic Cancer Drug: Nivolumab Drug: Pembrolizumab Radiation: Radiotherapy Drug: Ipilimumab

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Investigation of the Timely-coordinated Therapy of Patients With Metastatic Cancer by Radiotherapy Together With Immune Checkpoint Inhibition
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : February 28, 2021
Estimated Study Completion Date : December 30, 2024
Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Radiation: Radiotherapy
The normal clinical treatment-plan of the underlying disease remains unchanged.

Drug: Ipilimumab
The normal clinical treatment-plan of the underlying disease remains unchanged.
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.
 Drug: Nivolumab
The normal clinical treatment-plan of the underlying disease remains unchanged.

Drug: Pembrolizumab
The normal clinical treatment-plan of the underlying disease remains unchanged.

Radiation: Radiotherapy
The normal clinical treatment-plan of the underlying disease remains unchanged.


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]
  2. Change of circulating immune cells of treated patients by deep immunophenotyping. [ Time Frame: The analyses are conducted at time points before (day 0) and before every prescription of ICI (every 14 to 21 days) till progression or end of study at day 540 ]
    Immunophenotyping of the patients: Detection of about 30 distinct immune sell (sub)types together with their activation markers. The analyses are conducted at time points before (day 0) and before every prescription of ICI (every 14 to 21 days) till progression or end of study at day 540.


Secondary Outcome Measures :
  1. Detection of adverse events according to NCI CTAE (v4.0) [ 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. ]
  2. Documentation of corticoid prescription [ 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. ]
  3. Overall survival [ Time Frame: Till death of the patient or end of study at day 540, whichever came first ]
  4. Progression free survival [ 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. ]

Biospecimen Retention:   Samples With DNA
Serum, Plasma, Blood cells, circulating DNA

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study cohort consist of patients suffering from metastatic cancer of several entities which will be treated with optionally RT (if indicated) and/or ICI at Department of Radiation Oncology of Universitätsklinikum Erlangen.

Both gender are included into the study, a maximum age was not defined.

Criteria

Inclusion Criteria:

  • Patients suffering and diagnosed for: metastatic cancer of several entities
  • Clinical indicated therapy with PD-1/PD-L1 inhibitors or CTLA-4 antagonists
  • Optionally radiotherapy if clinically indicated
  • Age at least 18 years

Exclusion Criteria:

  • fertile patients who refuse effective contraception during study treatment
  • persistent drug and/or alcohol abuse
  • patients not able or willing to behave according to study protocol
  • patients in care
  • patients that are not able to speak German
  • patients which are imprisoned according to legal or governmental order
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453892


Locations
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Germany
Department of Radiation Oncology, Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Study Chair: Rainer Fietkau, Prof. Dr. Department of Radiation Oncology, Universitätsklinikum Erlangen
Study Director: Markus Hecht, Dr. med. Department of Radiation Oncology, Universitätsklinikum Erlangen
Study Director: Udo S Gaipl, Prof. Dr. Department of Radiation Oncology, Universitätsklinikum Erlangen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03453892    
Other Study ID Numbers: ST-ICI
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Erlangen-Nürnberg Medical School:
Metastatic cancer
Radiotherapy
Immunotherapy
radioimmuno therapy
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes
Pembrolizumab
 Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action