RecruitingPhase 2NCT05229614

Immunotherapy and Carbon Ion Radiotherapy In Solid Cancers With Stable Disease

Immune Checkpoint Inhibitors and Carbon iON Radiotherapy In Solid Cancers With Stable Disease

Sponsor

CNAO National Center of Oncological Hadrontherapy

Enrollment

27 participants

Start Date

Jul 26, 2022

Study Type

INTERVENTIONAL

Conditions

Urothelial Carcinoma Melanoma Non-small Cell Lung Cancer Head and Neck Squamous Cell Carcinoma

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding a single session of carbon ion radiotherapy (a precise form of high-energy radiation) can boost the immune response and overcome stable or slow-progressing disease in cancer patients already receiving checkpoint inhibitor immunotherapy. **You may be eligible if...** - You have a confirmed solid tumor currently being treated with an anti-PD1/PDL1 immunotherapy drug - Your disease is stable (not progressing or shrinking) on immunotherapy - You have at least one tumor site that can be safely treated with carbon ion radiation - You meet cohort-specific criteria for your cancer type **You may NOT be eligible if...** - Your cancer is actively progressing on immunotherapy - You have had prior radiation to the site being considered for treatment - You have active autoimmune disease requiring systemic treatment - You have severe organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONCarbon Ion Therapy

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.

DRUGImmunotherapy (Pembrolizumab)

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.