NCT05229614|UnknownPhase 2
Immunotherapy and Carbon Ion Radiotherapy In Solid Cancers With Stable Disease
ICONIC
Immune Checkpoint Inhibitors and Carbon iON Radiotherapy In Solid Cancers With Stable Disease
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ICONIC
Immune Checkpoint Inhibitors and Carbon iON Radiotherapy In Solid Cancers With Stable Disease
Sponsor study identifier
interventional
27
2 countries
4
Study Start
July 26, 2022
Actual (reported)Primary Completion
August 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Immunotherapy has become the standard of care in different advanced malignancies. Its effectiveness in the palliative setting was demonstrated by several phase III trials. However, the response rate varies according to the cancer under study and to the line of treatment. A potential way to improve the activity of single agent immune checkpoint inhibitors (ICIs) is to enhance the clinical response through further antitumor agents, including radiotherapy. Studies showed that carbon ions may lead to a broader immunogenic response; for their dosimetric characteristics it is possible to reduce integral dose sparing immune cells to direct and sustain a tumor specific immune response. Considering the available preclinical and clinical evidence together, the goal of this study is to explore the feasibility and the clinical activity of adding carbon ion radiotherapy (CIRT), employed with a fractionation strategy comparable to stereotactic body radiation, to ICIs in advanced malignancies where immunotherapy is currently the standard of care.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 10, 2022
Actual (reported)February 8, 2022
Actual (reported)July 26, 2022
Actual (reported)August 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Objective response rate assessed by RECIST V1.1
To estimate the effect, in terms of clinical response, of immunotherapy associating carbon ion treatment (CIRT) in the palliative setting across different malignancies, for which immunotherapy is currently the standard of care. Objective response rate (ORR) will be evaluated after CIRT administrated during immunotherapy maintenance in patients with stable disease. ORR will be assessed in the whole population according to RECIST v1.1. The proportion of ORR will be estimated within each disease.
At least 8 weeks
Treatment-related adverse events assessed by CTCAE V5.0
At least 8 weeks
Efficacy in terms of survival
Only cancer patients under treatment with pembrolizumab monotherapy, administered within clinical practice and according to the Italian Drug Regulatory Agency (Agenzia Italiana del Farmaco, AIFA), will be enrolled. Patients diagnosed with NSCLC, HNSCC, melanoma and urothelial carcinoma will be eligible for the study.
After confirming the disease stability and upon patient inclusion in the study, hypofractionated carbon ion boost will be administered to one site of disease previously untreated. Patient will be irradiated to a single lesion with a total dose of 24 Gy\[RBE\], 8 Gy\[RBE\]/fraction, one fraction/day, for 3 days.
Only cancer patients under treatment with pembrolizumab monotherapy, administered within clinical practice and according to the Italian Drug Regulatory Agency (Agenzia Italiana del Farmaco, AIFA), will be enrolled.
GSI Helmholtzzentrum für Schwerionenforschung GmbH
Darmstadt, Germany
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
National Center for Oncological Hadrontherapy (CNAO)
Pavia, 27100, Italy
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Viviana Vitolo, MD
Fondazione CNAO
First Submitted
January 10, 2022
First Posted
February 8, 2022
Study Start
July 26, 2022
Actual (reported)Primary Completion
Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors
At least 8 weeks
Contact the study team to confirm eligibility.
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
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Cavalieri S, Vitolo V, Barcellini A, Ronchi S, Facoetti A, Campo C, Klersy C, Molinelli S, Agustoni F, Ferretti VV, Silvestri A, Platania M, Del Vecchio M, Durante M, Helm A, Fournier C, Braud F, Pedrazzoli P, Orlandi E, Licitra L. Immune checkpoint inhibitors and Carbon iON radiotherapy In solid Cancers with stable disease (ICONIC). Future Oncol. 2023 Jan;19(3):193-203. doi: 10.2217/fon-2022-0503. Epub 2023 Mar 28.
August 2025
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 21, 2024
Record last verified: 2024-08
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