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

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ClinicalTrials.gov Identifier: NCT03453892
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Tracking Information
First Submitted Date January 24, 2018
First Posted Date March 5, 2018
Last Update Posted Date April 5, 2018
Actual Study Start Date April 1, 2017
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 2, 2018)
  • 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. ]
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03453892 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 2, 2018)
  • 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. ]
  • 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. ]
  • Overall survival [ Time Frame: Till death of the patient or end of study at day 540, whichever came first ]
  • 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. ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Investigation of the Timely-coordinated Therapy of Patients With Metastatic Cancer by Radiotherapy Together With Immune Checkpoint Inhibition
Official Title Investigation of the Timely-coordinated Therapy of Patients With Metastatic Cancer by Radiotherapy Together With Immune Checkpoint Inhibition
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Serum, Plasma, Blood cells, circulating DNA
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 palliative RT and/or ICI at Department of Radiation Oncology of Universitätsklinikum Erlangen.

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

Condition Metastatic Cancer
Intervention
  • 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.
  • Drug: Ipilimumab
    The normal clinical treatment-plan of the underlying disease remains unchanged.
Study Groups/Cohorts
  • 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.
    Interventions:
    • Radiation: Radiotherapy
    • Drug: Ipilimumab
  • 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.
    Interventions:
    • Drug: Nivolumab
    • Drug: Pembrolizumab
    • Radiation: Radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 2, 2018)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility 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 as well as planned palliative radiotherapy
  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Benjamin Frey, Dr.-Ing. +49 9131 85 ext 44248 benjamin.frey@uk-erlangen.de
Contact: Markus Hecht, Dr. med. +49 9131 85 ext 33405 markus.hecht@uk-erlangen.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03453892
Other Study ID Numbers ST-ICI
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University of Erlangen-Nürnberg Medical School
Study Sponsor University of Erlangen-Nürnberg Medical School
Collaborators Not Provided
Investigators
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
PRS Account University of Erlangen-Nürnberg Medical School
Verification Date April 2018