NCT03416244

A Multicenter Open-label Phase II Trial to Evaluate Nivolumab and Ipilimumab for 2nd Line Therapy in Elderly Patients With Advanced Esophageal Squamous Cell Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

Cancer - including esophageal squamous cell cancer (ESCC) - is a disease of the elderly but little is known about the biology and progression of cancers in these patients. While most patients receive chemotherapy and/or chemo-radiation as first treatment, no treatment standard for following treatments has been established so far and there is a clear unmet medical need, especially for elderly patients. Hence, this study assesses the efficacy and safety of two experimental immunotherapy regimens (Nivolumab monotherapy or Nivolumab/Ipilimumab combination) in elderly patients with advanced esophageal squamous cell cancer.

Detailed description

Cancer - including esophageal squamous cell cancer (ESCC) - is a disease of the elderly, more than 60% of all tumors arise in patients with the age of 65 years or older. In contrast, little is known about the biology and progression of cancers in these patients, since most clinical trials enroll patients with age limits of 70 or 75 years. While most patients undergo chemotherapy and/or chemo-radiation in first-line, the role of second-line therapy is less well understood. No treatment standard has been established so far and there is a clear unmet medical need. This is particularly true for geriatric patients for whom palliative systemic therapies are especially challenging. Hence, the primary objective of this trial is to demonstrate a significant survival benefit of two experimental immunotherapy regimens (Nivolumab monotherapy or Nivolumab/Ipilimumab combination) in elderly patients with advanced esophageal squamous cell cancer compared to historical data of standard chemotherapy regimens.

Conditions

• Esophageal Cancer
• Oesophageal Cancer
• Oesophageal Cancer Metastatic
• Esophageal Cancer Metastatic
• Esophageal Cancers NOS
• Oesophageal Cancer Nos
• GastroEsophageal Cancer
• Gastrooesophageal Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab 240 mg IV fixed dose every two weeks
DRUG	Ipilimumab	Ipilimumab 1mg/kg IV every six weeks (starting in week 7 after safety assessment)

Timeline

• Start date: 2018-02-21
• Primary completion: 2021-11-19
• Completion: 2021-11-19
• First posted: 2018-01-31
• Last updated: 2022-09-29

Locations

1 site across 1 country: Germany