Immunotherapy and Carbon Ion Radiotherapy In Solid Cancers With Stable Disease

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05229614

Studienbeginn:
Juli 2022

Letztes Update:
25.05.2023

Wirkstoff:
Immunotherapy (Pembrolizumab)

Indikation (Clinical Trials):
Carcinoma, Melanoma, Squamous Cell Carcinoma of Head and Neck

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
CNAO National Center of Oncological Hadrontherapy

Collaborator:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy, GSI Helmholtzzentrum für Schwerionenforschung GmbH, Darmstadt, Germany,

Studienleiter

Viviana Vitolo, MD
Principal Investigator
Fondazione CNAO

Kontakt

Chiara Campo, PhD
Kontakt:
Phone: +39 0382078407
E-Mail: campo@cnao.it» Kontaktdaten anzeigen

Cristina Bono
Kontakt:
Phone: +39 0382078613
E-Mail: bono@cnao.it» Kontaktdaten anzeigen

Studienlocations
(3 von 4)

GSI Helmholtzzentrum für Schwerionenforschung GmbH
Darmstadt
(Hessen)
GermanyAktiv, nicht rekrutierend» Google-Maps

Fondazione IRCCS Istituto Nazionale dei Tumori
MIlan
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Filippo De Braud, Prof., MD» Ansprechpartner anzeigen

National Center for Oncological Hadrontherapy (CNAO)
27100 Pavia
ItalyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Chiara Campo, PhD
Phone: +39 0382-078 407
E-Mail: campo@cnao.it

Cristina Bono
Phone: +39 0382078613
E-Mail: bono@cnao.it» Ansprechpartner anzeigen

Fondazione IRCCS Policlinico San Matteo
Pavia
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Paolo Pedrazzoli, Prof., MD» Ansprechpartner anzeigen

Alle anzeigen

Studien-Informationen

Detailed Description:

This is a multicenter, open label, non-randomized phase II clinical trial aiming to assess

the feasibility and the clinical activity of adding CIRT to ICIs in cancer patients that have

obtained a disease stability (SD) with pembrolizumab administered as per standard of care. At

study entry, hypofractionated CIRT will be delivered to one measurable lesion previously

untreated with local approaches.CIRT will be performed at Fondazione CNAO, Pavia

Ein-/Ausschlusskriterien

Inclusion Criteria:

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:

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)

Studien-Rationale

Primary outcome:

1. Objective response rate assessed by RECIST V1.1 (Time Frame - At least 8 weeks):
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.

Secondary outcome:

1. Treatment-related adverse events assessed by CTCAE V5.0 (Time Frame - At least 8 weeks):
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. Treatment-related adverse events will be evaluated according to CTCAE version 5.0.

2. Efficacy in terms of survival (Time Frame - At least 8 weeks):
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. Progression-Free Survival (PFS) will be calculated as the time between the start date of immunotherapy associated with carbon ion and the progression of disease, or death or last-follow-up. PFS will be estimated, within each malignancy, by Kaplan-Meier product limit method. Overall survival (OS) will be calculated as the time between the start date of immunotherapy associated with carbon ion and the death for any cause or last follow-up. OS will be estimated, within each malignancy, by Kaplan-Meier product limit method.

Geprüfte Regime

Carbon 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.
Immunotherapy (Pembrolizumab) (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.

Quelle: ClinicalTrials.gov

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