Immunotherapy with carbon ion radiotherapy for certain advanced cancers
Tests immunotherapy plus carbon ion radiotherapy in adults with advanced cancers.
Plain-language title generated from the registry record
Registry title: Immune checkpoint inhibitors and Carbon iON radiotherapy In solid Cancers with stable disease (ICONIC)
Key facts
- Where
- Milan and Pavia, ItalySee the 3 sites
- Phase
- Phase 2
Where in Italy
- Istituto Nazionale dei TumoriMilan, ItalyNot yet recruiting
- Fondazione Centro Nazionale Di Adroterapia OncologicaPavia, ItalyNot yet recruiting
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Centro Nazionale Di Adroterapia Oncologica
- Trial code
- NCT05229614EU 2024-517378-22-00
- Record updated
- 26 November 2024
- Original description
To estimate the effect, in terms of clinical response, of immunotherapy associating carbon ion treatment in the palliative setting across different malignancies, for which immunotherapy is currently the standard of care.Read full original descriptionShow less
Immune checkpoint inhibitors and Carbon iON radiotherapy In solid Cancers with stable disease (ICONIC)
To estimate the effect, in terms of clinical response, of immunotherapy associating carbon ion treatment in the palliative setting across different malignancies, for which immunotherapy is currently the standard of care.
Inclusion: Signed written informed consent; Histologic confirmation of malignancies under treatment with single agent anti-PD1/PDL1 immunotherapy per clinical practice (see cohort specific inclusion criteria) with immune checkpoint inhibitors approved by Italian national drug regulatory agencies (Agenzia Italiana del Farmaco, AIFA); Having a disease stability as assessed by AIFA monitoring sheet; Presence of at least 2 measurable target lesions, of which at least one to be followed up as per RECIST and one suitable for CIRT; Willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study; Females and males, 18 years of age or older (no upper limit for age); Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; Subjects must have measurable disease by CT or MRI per RECIST 1.1.
Exclusion: Patients treated with chemo-immunotherapy associations; Any CTCAE grade ≥3 immune-related adverse event observed within 3 weeks prior to CIRT start; Patients treated with immunotherapy combinations (e.g. subjects treated with anti-CTLA4 + anti-PD1/PDL1 are excluded); Patients receiving immunotherapy within clinical trials; Patients receiving off-label immunotherapy or within expanded access programs or as compassionate use; Previous RT, regardless of energy, on the metastatic site selected to be irradiated; Presence of metal prostheses or any other condition to prevent adequate imaging for identification of the target volume and calculation of the dose; Loco-regional conditions not allowing hadron therapy (e.g. active infections in RT target region); Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness (e.g. infectious disease); Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results; Patients with autoimmune diseases (ADs), including local and systemic collagen-vascular (CVD) and inflammatory bowel diseases (IBD); Any immune-related CTCAE grade 4 adverse event, before study entry; Prisoners or subjects who are involuntarily incarcerated; Patients with high tumor burden defined as > 10 lesions and/or sum of diameters > 19 cm; Patients with distant metastases only located in the CNS are excluded.