Program Status
Active, not recruitingPhase
Phase 2Prior Immunotherapy Allowed
NoCRC-directed Trial
NoDrugs
Alectinib, Atezolizumab, Brigatinib, Cobimetinib, Entrectinib, Erlotinib, everolimus, Ipatasertib, Ipilimumab, Itacitinib, Lapatinib, Nivolumab, Oncology Drugs, palbociclib, Pemigatinib, Pertuzumab, Ponatinib, Trastuzumab, Trastuzumab emtansine, Vemurafenib, VismogedibTags
MSS/ MMRpLocation | Location Status |
---|---|
Italy | |
OSPEDALI RIUNITI di ANCONA Ancona |
Active, not recruiting |
Centro Riferimento Oncologico Aviano |
Active, not recruiting |
Irccs Oncologico Istituto Tumori Giovanni Paolo Ii - Bari Bari |
Active, not recruiting |
Asst Papa Giovanni Xxiii Bergamo |
Active, not recruiting |
Ospedale Bellaria Bologna |
Active, not recruiting |
Ospedale di Carpi Carpi |
Active, not recruiting |
Arnas Garibaldi- Nuovo Ospedale Garibaldi - Nesima Catania |
Active, not recruiting |
A.O. Mater Domini Catanzaro Catanzaro |
Active, not recruiting |
Azienda Ospedaliero-Universitaria Di Ferrara Ferrara |
Active, not recruiting |
E.O. Ospedali Galliera Genova |
Active, not recruiting |
Ospedale Policlinico San Martino Genova |
Active, not recruiting |
Ospedale Della Misericordia Grosseto |
Active, not recruiting |
I.R.S.T. Srl Irccs Meldola |
Active, not recruiting |
Ao Papardo Messina |
Active, not recruiting |
Istituto Europeo Di Oncologia Milano |
Active, not recruiting |
Istituto Nazionale Tumori Di Napoli Irccs Pascale Napoli |
Active, not recruiting |
Ospedale Classificato Sacro Cuore - Don Calabria Negrar |
Active, not recruiting |
I.R.C.C.S. Istituto Oncologico Veneto Padova |
Active, not recruiting |
Az.Osp.Univ.P.Giaccone Palermo |
Active, not recruiting |
Azienda Ospedaliera Di Perugia Perugia |
Active, not recruiting |
Casa Di Cura Privata Osp. P. Pederzoli Peschiera Del Garda |
Active, not recruiting |
Azienda Usl Di Piacenza Piacenza |
Active, not recruiting |
Azienda Ospedaliero-Universitaria Pisana Pisa |
Active, not recruiting |
Nuovo Ospedale Di Prato - S. Stefano Prato |
Active, not recruiting |
Ospedale "Santa Maria Delle Croci" Ravenna |
Active, not recruiting |
Arcispedale Santa Maria Nuova Di Reggio Emilia Reggio Emilia |
Active, not recruiting |
Az. Osp. Uni. Policlinico Umberto I Roma |
Active, not recruiting |
Azienda Ospedaliera Sant'Andrea Roma |
Active, not recruiting |
Istituti Fisioterapici Ospitalieri- Ifo - Istituto Regina Elena Roma |
Active, not recruiting |
Ospedale Fatebenefratelli Roma |
Active, not recruiting |
Policl. Univ. Campus Bio Medico Roma |
Active, not recruiting |
Casa Sollievo della Sofferenza - Opera Padre Pio San Giovanni Rotondo |
Active, not recruiting |
Azienda Ospedaliera 'S. Maria' - Terni Terni |
Active, not recruiting |
AO Ordine Mauriziano Torino |
Active, not recruiting |
Humanitas Gradenigo Torino |
Active, not recruiting |
IRCCS Candiolo Torino |
Active, not recruiting |
Complesso Ospedaliero Di Belcolle- Ospedale Di Belcolle Viterbo |
Active, not recruiting |
Inclusion Criteria
Inclusion Criteria:
Age ≥ 18 at time of signing Informed Consent Form
Patients able and willing to provide a written informed consent to participate to the study
Patients with recurrent/metastatic breast, gastrointestinal cancer,non small cell lung cancer or others
Patients not treatable with potentially curative surgery ot other loco-regional treatments.
Patients should have been completed at least or failed the first line of treatment for breast cancer, gastro-intestinal, non small cell lung cancer or other cancer
ECOG performance status from 0 to 1
Molecular target not actionable with approved drugs identified during screening by profiling with FoundationOne CDX on biopsy and FoundationOne Liquid CDx on blood
Biopsiable disease (tumor biopsy mandatory for tumor profiling). The biopsy must be performed during the screening period, when patients complete the conventional therapy for their recurrent/metastatic cancer. Historical samples will be considered for the study if collected within 3 months before the ICF signature of the patient. Samples older than 3 months, with a maximum timeframe of 6 months, and collected before progression of disease after the last treatment administered will be considered upon clinical judgement of the Investigator, after confirmation by the coordinating site or MTB. Samples obtained from a biospy of a metastatic lesion in progression after the last treatment administered represent the optimal tissue sample for genomic testing. Patients with glioblastomas and high grade malignant gliomas can be enrolled with the historical tissue samples.
Measurable disease, eligible to standard treatment. Patients must have measurable or evaluable disease defined, per RECIST 1.1 or irCS (immune related Response Criteria), as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral computed tomography (CT) scan, Magnetic Resonance Imaging (MRI), or a subcutaneous or superficial lesion that can be measured with calipers by clinical exam. For lymph nodes, the short axis must be ≥15 mm. Patients who have assessable disease by physical or radiographic examination but do not fully meet the above definitions of measurable disease (but still remains measurable) are eligible and will be considered to have evaluable disease. Patient's whose disease cannot be objectively measured by physical or radiographic examination (e.g., elevated serum tumor marker only) are NOT eligible. PET scan could be performed, if clinically indicated. For PET response evaluation PERCIST criteria will be applied.
Adequate renal function defined by a serum creatinine <1.5xUNL (upper normal limit).
Adequate liver function test defined by SGOT & SGPT <3xUNL (5xUNL in case of liver metastases), and bilirubin level 100,000/mm3, hemoglobin >10 g/dL, and neutrophils >1,000/mm3
For female of child-bearing potential and for all women < 1 years after the onset of menopause: a negative pregnancy test 2 months
Patients with well-established actionable targets for which approved and marketed targeted drugs are available (i.e. lung cancer with EGFR mutation, or ALK translocation, B-RAF mutant melanoma, GIST with KIT mutations or breast cancer with HER2 amplification)
Patient participating in another clinical trial with an experimental drug
Anticoagulation with anti-vitamin K (Low Molecular Weight Heparin [LMWH] is allowed)
Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, including uncontrolled diabetes, cardiac disease, uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within one year, chronic liver or renal disease, active gastrointestinal tract ulceration, severely impaired lung function
Pregnant and/or breastfeeding women
Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
HIV, HBV, or HCV infection as per specific test performed at the screening visit or known as per Medical History
Patients with documented contraindication to any of the IMPs that will be used for the study, as reported in the respective SmPcs/IBs and in Appendix 2
Patients treated with the following drugs, because of the risk of immunosuppression: Chronic or high-dose oral corticosteroid therapy, TNF-inhibitors and Anti-T cell antibodies