NCT03453892: ST-ICI

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

Completed Last updated 16 February 2023

What this trial tests

trial testing Nivolumab in Metastatic Cancer in 150 participants. Completed in 30 December 2022.

Timeline

1 April 2017

Primary endpoint
28 February 2021

30 December 2022

Quick facts

Lead sponsor	University of Erlangen-Nürnberg Medical School
Status	Completed
Study type	OBSERVATIONAL
Enrollment	150
Start date	1 April 2017
Primary completion	28 February 2021
Estimated completion	30 December 2022
Sites	1 location across Germany

Drugs / interventions tested

• Nivolumab (nivolumab) — full drug profile →
• Pembrolizumab (pembrolizumab) — full drug profile →
• Radiotherapy
• Ipilimumab — full drug profile →

Conditions studied

• Metastatic Cancer — all drugs for Metastatic Cancer →

Sponsor

University of Erlangen-Nürnberg Medical School

Who can join

18 and older, any sex, with Metastatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting zonulin and intestinal epithelial barrier function to prevent onset of arthritis.
   Tajik N, Frech M, Schulz O, Schälter F, et al · · 2020 · cited 355× · PMID 32332732 · DOI 10.1038/s41467-020-15831-7
2. Radiomics to predict outcomes and abscopal response of patients with cancer treated with immunotherapy combined with radiotherapy using a validated signature of CD8 cells.
   Sun R, Sundahl N, Hecht M, Putz F, et al · · 2020 · cited 67× · PMID 33188037 · DOI 10.1136/jitc-2020-001429
3. 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.
   Zhou JG, Donaubauer AJ, Frey B, Becker I, et al · · 2021 · cited 48× · PMID 33593828 · DOI 10.1136/jitc-2020-001845
4. Chemotherapy-induced metastasis: molecular mechanisms and clinical therapies.
   Su JX, Li SJ, Zhou XF, Zhang ZJ, et al · · 2023 · cited 32× · PMID 37169853 · DOI 10.1038/s41401-023-01093-8
5. Biomarkers for precision immunotherapy in the metastatic setting: hope or reality?
   Sajjadi E, Venetis K, Scatena C, Fusco N. · · 2020 · cited 29× · PMID 33574895 · DOI 10.3332/ecancer.2020.1150
6. Abscopal Effects in Metastatic Cancer: Is a Predictive Approach Possible to Improve Individual Outcomes?
   Link B, Torres Crigna A, Hölzel M, Giordano FA, et al · · 2021 · cited 20× · PMID 34768644 · DOI 10.3390/jcm10215124
7. Prospective Evaluation of All-lesion Versus Single-lesion Radiotherapy in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors.
   Schubert P, Rutzner S, Eckstein M, Frey B, et al · · 2020 · cited 11× · PMID 33251140 · DOI 10.3389/fonc.2020.576643
8. Questionnaire-based detection of immune-related adverse events in cancer patients treated with PD-1/PD-L1 immune checkpoint inhibitors.
   Griewing LM, Schweizer C, Schubert P, Rutzner S, et al · · 2021 · cited 10× · PMID 33761922 · DOI 10.1186/s12885-021-08006-0