The purpose of the trial is to assess the immunological effects and their kinetics, the safety and activity of IMAB362 plus Zoledronic acid with/without low to intermediate doses of Interleukin-2 in subjects with advanced gastroesophageal cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Enrollment
29
800 mg/m2 on d 1 of cycle 1. 600 mg/m2 on d 1 of every other cycle
4 mg on d 1 of cycle 1 and cycle 3
1 million IU on day 1, 2 and 3 of cycles 1 and 3.
Institut für Klinische Forschung, Krankenhaus Nordwest GmbH
Frankfurt am Main, Hesse, Germany
BAG / Onkologische Schwerpunktpraxis
Dresden, Saxony, Germany
Charité Universitätsmedizin Berlin - CVK, Med. Klinik m.S. Hämatologie und Onkologie
Berlin, Germany
Safety and Tolerability
Descriptive statistics for treatments will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped.
Time frame: at least 18 months
Immune cell profile and kinetics
Descriptive statistics for treatments will be given on the number and activity of immune cells in peripheral blood of patients.
Time frame: at least 18 months
Progression-free survival (PFS)
PFS is defined as the time from registration of therapy to the first observation of disease progression or death from any cause or last tumor evaluation if free of progression. For patients who have not progressed either clinically or on the last scan, they will be censured as of the last tumor evaluation.
Time frame: at least 18 months
Objective tumor response rate (ORR)
ORR comprises the fraction of patients with CR, PR according to RECIST v1.1. It is set in relation to the ITT population and PP population.
Time frame: at least 18 months
Disease control rate (DCR)
DCR is defined as the fraction of patients with CR or PR or SD according to RECIST v1.1. It is set in relation to the ITT population and PP population.
Time frame: at least 18 months
Duration of response (DOR)
Duration of response is determined as the time when criteria for CR, PR, and SD are first met until the first date that recurrent or progressive disease or death occurs.
Time frame: at least 18 months
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3 million IU on day 1, 2 and 3 of cycles 1 and 3.
Freiburg University Medical Center, Department of Internal Medicine II, Gastroenterology and Hepatology
Freiburg im Breisgau, Germany
Leipzig University Hospital, University Cancer Center (UCCL)
Leipzig, Germany
University Hospital Tuebingen, Department of Internal Medicine I - Gastroenterology, Hepatology, Infectious Diseases
Tübingen, Germany
Ulm University Hospital, Center for Internal Medicine
Ulm, Germany
Piejuras Hospital, Oncology Clinic
Liepāja, Latvia
Riga East University Hospital, LLC, Latvian Oncology Center
Riga, Latvia