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Immune checkpoint inhibitors and Carbon iON radiotherapy In solid Cancers with stable disease (ICONIC)
EU CTIS ID: 2024-517378-22-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- Patients treated with chemo-immunotherapy associations
- Any immune-related CTCAE grade 4 adverse event, before study entry
- Any CTCAE grade ≥3 immune-related adverse event observed within 3 weeks prior to CIRT start
- 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)
- Prisoners or subjects who are involuntarily incarcerated
See the full eligibility criteria
- 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
- Patients treated with chemo-immunotherapy associations
- Any immune-related CTCAE grade 4 adverse event, before study entry
- Any CTCAE grade ≥3 immune-related adverse event observed within 3 weeks prior to CIRT start
- 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)
- Prisoners or subjects who are involuntarily incarcerated
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness (e.g. infectious disease)
- 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
- 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
- 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)
- Previous RT, regardless of energy, on the metastatic site selected to be irradiated
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.