An observational study in Metastatic Cancer, sponsored by University of Erlangen-Nürnberg Medical School. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-16.
Sponsored by University of Erlangen-Nürnberg Medical School · Observational
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Among 323 studies in Neoplasm Metastasis with a site in Germany — 52 open to participants now, 91 under way, 36 of them phase 3. Neoplasm Metastasis · Germany.
Among the 323 studies in Neoplasm Metastasis with a site in Germany, this one is the 20th largest by enrollment of the 25 observational ones that give a count, is one of 13 that started in 2017, is one of 25 observational ones, and was the 197th registered.
4,045 studies on the registry are indexed under Neoplasm Metastasis; 888 are open to participants now.
Browse Neoplasm Metastasis studies →52 of the 323 studies in Neoplasm Metastasis with a site in Germany are open now. Recruiting first, the newest first:
AstraZeneca · Sites in Germany, United States, France and 6 more countries
Ages 18–130
Immuneering Corporation · Sites in Germany, United States, Australia and 6 more countries
Ages 18+
Pfizer · Sites in Germany, United States, Australia and 3 more countries
Ages 18+
Eikon Therapeutics · Sites in Germany, United States, Australia and 12 more countries
Ages 18+
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Sites in Germany
Ages 18+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 689 Neoplasm Metastasis studies recruiting now, 536 (78%) set no upper age limit and 97 (14%) stop at 75 or younger; 48 take children under 18; 18 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
323 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 67 · Phase 2 121 · Phase 3 119 · Phase 4 9
First in 1991; this study’s year is marked. 13 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 150 is close to the median of 137 across 560 observational studies indexed under Neoplasm Metastasis.
Median enrollment 214 across the 292 interventional studies, 408 across the 25 observational. Of the 202 that completed or were terminated, 91 (45%) have results posted.
This tab as a report to print or save as PDF → With an account.
226 of 323 have an industry lead sponsor. The 10 most frequent:
University of Erlangen-Nürnberg Medical School is the lead sponsor of 277 studies on the registry; 53 are open to participants now.
University of Erlangen-Nürnberg Medical School has 3 studies filed under Neoplasm Metastasis — fewer than ten, so there is no comparison to draw.
25 of the studies in Neoplasm Metastasis with a site in Germany that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04784715Phase 3AstraZenecaTrastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09) | 2027-05-03 |
| NCT06103864Phase 3AstraZenecaA Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05) | 2027-07-28 |
| NCT06064877Phase 3AVEO Pharmaceuticals, Inc.A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma | 2027-08 |
| NCT07044336Phase 3AstraZenecaPuxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01) | 2027-10-15 |
| NCT06119581Phase 3Eli Lilly and CompanyA Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer | 2027-11 |
Add all 25 to your calendar (.ics) → With an account.
Among the 323 studies in Neoplasm Metastasis with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Drug: Ipilimumab
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 · Drug: Pembrolizumab · Radiation: Radiotherapy
The normal clinical treatment-plan of the underlying disease remains unchanged.
The normal clinical treatment-plan of the underlying disease remains unchanged.
The normal clinical treatment-plan of the underlying disease remains unchanged.
The normal clinical treatment-plan of the underlying disease remains unchanged.
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.
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.
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
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.
Plan to share: Undecided
Ran from Apr 2017 to primary completion in Feb 2021, 46 months.
Of 211 non-industry observational studies under Neoplasm Metastasis, half reached primary completion within 75 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 172. This study's 46 months is below that.
Counting every sponsor, half of 242 studies reached it within 66 months; a quarter within 35 and three quarters within 172.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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University of Erlangen-Nürnberg Medical School →