EUCTR2018-000053-53-ES
Active, not recruiting
Phase 1
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 enrollmentJuly 17, 2018
Conditionsoesophageal squamous cell carcinoma and oeasophageal adenocarcinomaMedDRA version: 20.0Level: PTClassification code 10061534Term: Oesophageal squamous cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10030137Term: Oesophageal adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- oesophageal squamous cell carcinoma and oeasophageal adenocarcinoma
- Sponsor
- European Organisation for Research and Treatment of Cancer
- Enrollment
- 130
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically proven oesophageal squamous cell carcinoma or adenocarcinoma
- •Both early stage and locally advanced tumor patients (according to TNM staging version 8\):
- •T1, N1\-3, M0 after complete work\-up
- •T2, N0\-3, M0 after complete work\-up
- •T3, N0\-3, M0
- •Patient eligible for definitive chemoradiation and not considered for primary surgery after multidisciplinary meeting decision or patient refuses to undergo surgery
- •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
- •Age \= 18 years
Exclusion Criteria
- •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
- •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
- •History of hypersensitivity to study drugs or any excipient (refer to SmPCs for ipilimumab, nivolumab, 5\-FU and oxaliplatin)
- •Current participation or treatment with an investigational agent or use of an investigational agent within 4 weeks of the first dose of study treatment
Outcomes
Primary Outcomes
Not specified
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