Phase II trial in inoperable œsophageal cancer evaluating the feasibility of the combination of definitive chemoradiation with the immune checkpoint blockers Nivolumab +/- Ipilimumab (CRUCIAL) - CRUCIA

European Organisation for Research and Treatment of Cancer0 sites130 target enrollmentNovember 26, 2018

Overview

No summary available.

Registry

who.int

Start Date

November 26, 2018

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

European Organisation for Research and Treatment of Cancer

•Histologically proven oesophageal squamous cell carcinoma or adenocarcinoma
•Both early stage and locally advanced tumor patients (according to TNM staging version 8\):
•Any stage III or any stage IVA
•Stage IIA and IIB, only if not operable after complete work up
•If squamous cell carcinoma, T1 N1 M0, only if not operable after complete work up
•Patient eligible for definitive chemoradiation and not considered for primary surgery after multidisciplinary meeting decision or patient refuses to undergo surgery
•Prior surgery, other than surgery for primary tumor, is allowed if completed at least 4 weeks before randomization
•Subject must be previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease
•At least one measurable lesion by CT scan or MRI based on RECIST version 1\.1 with radiographic tumor assessment performed within 28 days prior to randomization
•Availability of adequate tissue for immunohistochemical staining

•Cancer of cervical oesophagus (15 to 19 cm from dental ridge)
•Known Her2 positive adenocarcinoma
•Weight loss \> 15 % over the last 3 months without improvement after nutritional support
•Patient with cardiac dysfunction e.g. symptomatic congestive heart failure, uncontrolled hypertension, myocardial infarction within 6 months prior to randomization, clinically significant active heart disease
•Mean resting corrected QT interval (QTc) \>450 msec for men and \>470 msec for women, obtained from 3 ECGs using local clinic ECG machine\-derived QTcF value
•Personal or family history of congenital long QT syndrome
•Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS), hepatitis B or hepatitis C.
•Note: Testing for HIV must be performed at sites where mandated locally.
•Any prior treatment for advanced disease including treatment with an anti\-Programmed Death receptor\-1 (PD\-1\), anti\-Programmed Death\-1 ligand\-1 (PD\-L1\), anti\-PD\-L2, anti\-cytotoxic T lymphocyte associated antigen\-4 (anti\-CTLA\-4\) antibody or any other antibody or drug specifically targeting T\-cell co\-stimulation or checkpoint pathways.
•Live vaccines within 30 days prior to the first dose of study therapy. Examples of live vaccines include, but are not limited to the following: measles, mumps, rubella, chicken pox, yellow fever, H1N1 flu, rabies, BCG, and typhoid vaccine