Safety and Feasibility of Irradiation and Nivolumab in Esophageal Cancer (INEC)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 54
Summary
- Conditions
- Esophageal Cancer
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Open-label, non-randomized, Parallell Groups, Study of Nivolumab and Radiotherapy in Patients With Esophageal CancerMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Three parallel cohort, multicenter, open-label, phase I/II clinical trial to analyze the safety and feasibility of PD-1 inhibition with Nivolumab given concomitantly with standard radiotherapy regimens in the treatment of esophageal cancer. Cohort A: Advanced/inoperable esophageal cancer, eligible f...
Three parallel cohort, multicenter, open-label, phase I/II clinical trial to analyze the safety and feasibility of PD-1 inhibition with Nivolumab given concomitantly with standard radiotherapy regimens in the treatment of esophageal cancer. Cohort A: Advanced/inoperable esophageal cancer, eligible for palliative radiotherapy of the primary tumor. Cohort B: Inoperable esophageal cancer without metastases, eligible for definitive chemoradiotherapy Cohort C: Operable esophageal cancer eligible for neoadjuvant chemoradiotherapy
Tracking Information
- NCT #
- NCT03544736
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Principal Investigator: Geir O. Hjortland Oslo University Hospital
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