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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

NCT03416244 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-09-29

No results posted yet for this study

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.

Conditions

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

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Matthias Ebert, Prof. Dr. · Universitätsmedizin Mannheim, Heidelberg University, II. Medizinische Klinik

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-21
Primary Completion
2021-11-19
Completion
2021-11-19

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03416244 on ClinicalTrials.gov