Metastatic CancerST-ICINCT03453892
Investigation of the Timely-coordinated Therapy of Patients With Metastatic Cancer by Radiotherapy Together With Immune Checkpoint Inhibition
An observational study of Metastatic Cancer, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- Nivolumab, Pembrolizumab and Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2017to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Radiation Oncology, Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
About this study
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.
- Conditions
- Metastatic Cancer
- Being tested
- Nivolumab, Pembrolizumab, Radiotherapy, Ipilimumab
- Keywords
- Metastatic cancer, Radiotherapy, Immunotherapy, radioimmuno therapy
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
The normal clinical treatment-plan of the underlying disease remains unchanged.
PembrolizumabDrug
The normal clinical treatment-plan of the underlying disease remains unchanged.
RadiotherapyRadiation
The normal clinical treatment-plan of the underlying disease remains unchanged.
IpilimumabDrug
The normal clinical treatment-plan of the underlying disease remains unchanged.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Nivolumab; Drug: Pembrolizumab; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic (according to iRECIST criteria) and local response of detected metastases during radio and/or immunotherapy.
Measured: 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.
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.
Measured: 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 outcomes (4)
Detection of adverse events according to NCI CTAE (v4.0)
Measured: 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
Measured: 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
Measured: Till death of the patient or end of study at day 540, whichever came first
Progression free survival
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start1 Apr 2017
- Primary completion28 Feb 2021
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rainer Fietkau, Prof. Dr., Study chair, Department of Radiation Oncology, Universitätsklinikum ErlangenMarkus Hecht, Dr. med., Study director, Department of Radiation Oncology, Universitätsklinikum ErlangenUdo S Gaipl, Prof. Dr., Study director, Department of Radiation Oncology, Universitätsklinikum Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453892
- Sponsor's protocol ID
- ST-ICI
- Acronym
- ST-ICI
- Status last verified
- Feb 2023
- First submitted
- 24 Jan 2018
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Griewing LM, Schweizer C, Schubert P, Rutzner S, Eckstein M, Frey B, Haderlein M, Weissmann T, Semrau S, Gostian AO, Muller SK, Traxdorf M, Iro H, Zhou JG, Gaipl US, Fietkau R, Hecht M. Questionnaire-based detection of immune-related adverse events in cancer patients treated with PD-1/PD-L1 immune checkpoint inhibitors. BMC Cancer. 2021 Mar 24;21(1):314. doi: 10.1186/s12885-021-08006-0.
PubMed 33761922Zhou JG, Donaubauer AJ, Frey B, Becker I, Rutzner S, Eckstein M, Sun R, Ma H, Schubert P, Schweizer C, Fietkau R, Deutsch E, Gaipl U, Hecht M. Prospective development and validation of a liquid immune profile-based signature (LIPS) to predict response of patients with recurrent/metastatic cancer to immune checkpoint inhibitors. J Immunother Cancer. 2021 Feb;9(2):e001845. doi: 10.1136/jitc-2020-001845.
PubMed 33593828
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Timely-coordinated Therapy of Patients With Metastatic Cancer by Radiotherapy Together With Immune Checkpoint Inhibition
- ClinicalTrials.gov ID
- NCT03453892
- Acronym / sponsor ID
- ST-ICI / ST-ICI
- Conditions
- Metastatic Cancer
- Keywords
- Metastatic cancer, Radiotherapy, Immunotherapy, radioimmuno therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 5 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anti CTLA-4 | – | Radiation: Radiotherapy, Drug: IpilimumabThe 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. |
| anti PD-1/PD-L1 | – | Drug: Nivolumab, Drug: Pembrolizumab, Radiation: RadiotherapyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabThe normal clinical treatment-plan of the underlying disease remains unchanged. | Drug | anti PD-1/PD-L1 |
| PembrolizumabThe normal clinical treatment-plan of the underlying disease remains unchanged. | Drug | anti PD-1/PD-L1 |
| RadiotherapyThe normal clinical treatment-plan of the underlying disease remains unchanged. | Radiation | anti CTLA-4, anti PD-1/PD-L1 |
| IpilimumabThe normal clinical treatment-plan of the underlying disease remains unchanged. | Drug | anti CTLA-4 |
Primary outcome
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.
4 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Derived from this study: PubMed 33761922Griewing LM, Schweizer C, Schubert P, Rutzner S, Eckstein M, Frey B, Haderlein M, Weissmann T, Semrau S, Gostian AO, Muller SK, Traxdorf M, Iro H, Zhou JG, Gaipl US, Fietkau R, Hecht M. Questionnaire-based detection of immune-related adverse events in cancer patients treated with PD-1/PD-L1 immune checkpoint inhibitors. BMC Cancer. 2021 Mar 24;21(1):314. doi: 10.1186/s12885-021-08006-0.
- Derived from this study: PubMed 33593828Zhou JG, Donaubauer AJ, Frey B, Becker I, Rutzner S, Eckstein M, Sun R, Ma H, Schubert P, Schweizer C, Fietkau R, Deutsch E, Gaipl U, Hecht M. Prospective development and validation of a liquid immune profile-based signature (LIPS) to predict response of patients with recurrent/metastatic cancer to immune checkpoint inhibitors. J Immunother Cancer. 2021 Feb;9(2):e001845. doi: 10.1136/jitc-2020-001845.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer Fietkau, Prof. Dr. study chair
Department of Radiation Oncology, Universitätsklinikum Erlangen
Markus Hecht, Dr. med. study director
Department of Radiation Oncology, Universitätsklinikum Erlangen
Udo S Gaipl, Prof. Dr. study director
Department of Radiation Oncology, Universitätsklinikum Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Cancer, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03453892, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.