Immune checkpoint inhibitors and Carbon iON radiotherapy In solid Cancers with stable disease (ICONIC)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fondazione Centro Nazionale Di Adroterapia Oncologica

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2024-11-26

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Fondazione Centro Nazionale di Adroterapia Oncologica

External identifiers

EU CT number

2024-517378-22-00

EudraCT number

2020-003680-25

ClinicalTrials.gov

NCT05229614

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

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.

Secondary objectives 2

1. To describe the safety profile of the association of carbon ion radiation therapy and systemic immunotherapy in the palliative setting across different malignancies, for which immunotherapy is currently the standard of care.
2. To estimate the effect, in terms of survival, of immunotherapy with the association of carbon ion radiation treatment in the palliative setting across different malignancies, for which immunotherapy is currently the standard of care.

Conditions and MedDRA coding

Unresectable or metastatic melanoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Signed written informed consent
2. 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)
3. Having a disease stability as assessed by AIFA monitoring sheet
4. 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
5. Willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
6. Females and males, 18 years of age or older (no upper limit for age)
7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
8. Subjects must have measurable disease by CT or MRI per RECIST 1.1

Exclusion criteria 15

1. Patients treated with chemo-immunotherapy associations
2. Patients treated with immunotherapy combinations (e.g. subjects treated with anti-CTLA4 + anti-PD1/PDL1 are excluded)
3. Patients receiving immunotherapy within clinical trials
4. Patients receiving off-label immunotherapy or within expanded access programs or as compassionate use
5. Patients with high tumor burden defined as > 10 lesions and/or sum of diameters > 19 cm
6. Patients with distant metastases only located in the CNS are excluded
7. 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
8. Patients with autoimmune diseases (ADs), including local and systemic collagen-vascular (CVD) and inflammatory bowel diseases (IBD)
9. Previous RT, regardless of energy, on the metastatic site selected to be irradiated
10. Any immune-related CTCAE grade 4 adverse event, before study entry
11. Any CTCAE grade ≥3 immune-related adverse event observed within 3 weeks prior to CIRT start
12. Presence of metal prostheses or any other condition to prevent adequate imaging for identification of the target volume and calculation of the dose
13. Loco-regional conditions not allowing hadron therapy (e.g. active infections in RT target region)
14. Prisoners or subjects who are involuntarily incarcerated
15. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness (e.g. infectious disease)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Objective response rate (ORR) according to RECIST, assessed at least 8 weeks after CIRT
2. Toxicity according to CTCAE version 5.0

Secondary endpoints 6

1. progression-free survival (PFS)
2. overall survival (OS)
3. objective response rate (ORR) according to irRECIST
4. percentage of patients with disease progression as best response
5. objective response of the metastatic lesion treated with CIRT
6. disease control rate (DCR) according to RECIST, defined as ORR+SD

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fondazione Centro Nazionale Di Adroterapia Oncologica

Sponsor organisation

Fondazione Centro Nazionale Di Adroterapia Oncologica

Address

Via Erminio Borloni 1

City

Pavia

Postcode

27100

Country

Italy

Scientific contact point

Organisation

Fondazione Centro Nazionale Di Adroterapia Oncologica

Contact name

Federica Serra

Public contact point

Organisation

Fondazione Centro Nazionale Di Adroterapia Oncologica

Contact name

Federica Serra

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications