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

Sponsor
AIO-Studien-gGmbH
Study ID
NCT03416244
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 21, 2018
Status verified
Sep 2022
Primary completion
Nov 19, 2021
Completion
Nov 19, 2021

Study Design

Enrollment
66 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A: Nivolumab / Ipilimumab combination treatment
    Nivolumab 240 mg fixed dose IV every 2 weeks; Additionally, after 7 week safety assessment Ipilimumab 1mg/kg IV every 6 weeks
  • Experimental: B. Nivolumab monotherapy
    Nivolumab 240 mg fixed dose IV every 2 weeks

Primary Outcome Measure

Overall survival [ Time Frame: 36 months ]

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