Spots Global Cancer Trial Database for Ipilimumab or FOLFOX in Combination With Nivolumab and Trastuzumab in HER2 Positive EsophagoGastric Adenocarcinoma
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Trial Identification
Brief Title: Ipilimumab or FOLFOX in Combination With Nivolumab and Trastuzumab in HER2 Positive EsophagoGastric Adenocarcinoma
Official Title: Ipilimumab or FOLFOX in Combination With Nivolumab and Trastuzumab in Previously Untreated HER2 Positive Locally Advanced or Metastatic EsophagoGastric Adenocarcinoma
Study ID: NCT03409848
Study Description
Brief Summary: The INTEGA study assesses therapy Options for advanced or metastatic esophagogastric Adenocarcinoma in patients overexpressing human epidermal receptor type 2 (HER2 positive patients). Current treatment options in this situation include chemotherapy based palliative treatment in combination withTrastuzumab. Recent studies have shown that immunotherapy with Nivolumab or Ipilimumab after previous chemotherapy can also improve survival in esophagogastric cancer. This study assesses the efficacy of two experimental first line treatment strategies: A) Chemo-free immunotherapy with Trastuzumab, Nivolumab and Ipilimumab and B) addition of Nivolumab to the standard regimen (FOLFOX chemotherapy and Trastuzumab).
Detailed Description: Gastric cancer is the fifth most common cancer in the world, and the third leading cause of cancer death in both sexes worldwide. Surgical resection is currently the only curative treatment option for gastric cancer; however, \~50% of patients have metastatic disease at the time of diagnosis and chemotherapy is the mainstay of palliation in this setting. Trastuzumab, in combination with chemotherapy, significantly improved survival in patients with overexpression of HER2. In regard of the very limited therapeutic landscape of HER2 positive EGA, compared to breast cancer, further treatment options to relevantly improve the outcome is warranted. The integration of check-point inhibitors (e.g. Nivolumab, Ipilimumab) into the first line setting either within a chemotherapy-free combination arm or within an intensified standard arm of FOLFOX and trastuzumab with nivolumab may be able to improve the current limited survival of median 14 months.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Gesundheitszentrum St. Marien Amberg - MVZ, Amberg, , Germany
Gesundheitszentrum Wetterau - Facharztzentrum, Bad Nauheim, , Germany
Helios Klinikum Bad Saarow - Hämatologie, Onkologie und Palliativmedizin, Bad Saarow, , Germany
Charité Universitätsmedizin Campus Virchow Klinikum - Hämatologie / Onkologie, Berlin, , Germany
Ev. Waldkrankenhaus Spandau - Onkologisches Zentrum, Berlin, , Germany
St. Josef Hospital Bochum - Hämatologie, Onkologie und Palliativmedizin, Bochum, , Germany
Schwerpunktpraxis Hämatologie und Onkologie Bottrop, Bottrop, , Germany
MVZ Klinikum Coburg, Coburg, , Germany
BAG Onkologische Gemeinschaftspraxis Dresden, Dresden, , Germany
Kliniken Essen-Mitte - Klinik für Internistische Onkologie und Hämatologie, Essen, , Germany
Krankenhaus Nordwest - Institut für klinische Forschung, Frankfurt a.M., , Germany
Uniklinikum Frankfurt - Med. I, Frankfurt a.M., , Germany
Universitätsklinikum Halle (Saale) - Innere Med. I, Halle (Saale), , Germany
Universitätsklinikum Hamburg Eppendorf - II. Med., Hamburg, , Germany
HOPE - Hämatologisch-onkologische Praxis Eppendorf, Hamburg, , Germany
Med. Hochschule Hannover - Gastroenterologie, Hepatologie und Endokrinologie, Hannover, , Germany
Universitätsklinikum Jena - Innere Med. Hämatologie und Onkologie, Jena, , Germany
DRK Kliniken Nordhessen - Klinik für interdisziplinäre Onkologie, Kassel, , Germany
Klinikum Kassel - Onkologie und Hämatologie, Kassel, , Germany
Ortenau-Klinikum Lahr - Sektion Hämatologie und Onkologie, Lahr, , Germany
MVZ-Mitte - Onkologische Schwerpunktpraxis Leipzig, Leipzig, , Germany
Universitätsklinikum Leipzig - Krebszentrum, Leipzig, , Germany
Klinikum Magdeburg - Hämatologie und Onkologie, Magdeburg, , Germany
Universitätsklinikum Marburg - Hämatologie, Onkologie und Immunologie, Marburg, , Germany
Stauferklinikum Schwäbisch Gmünd - Innere Med., Mutlangen, , Germany
Kliniken Maria Hilf Mönchengladbach - Hämatologie, Onkologie und Gastroenterologie, Mönchengladbach, , Germany
Klinikum der LMU München - Med. III, München, , Germany
Klinikum rechts der Isar der TU München - Innere Med. III, München, , Germany
Klinikum Oldenburg - Universitätsklinikum für Innere Med. - Onkologie und Hämatologie, Oldenburg, , Germany
Ermstalklinik Reutlingen - Med. I, Reutlingen, , Germany
Elblandklinikum Riesa - Innere Med., Riesa, , Germany
Leopoldina Krankenhaus Schweinfurt - Med. III, Schweinfurt, , Germany
Universitätsklinikum Ulm - Innere Med. I, Ulm, , Germany
Marien-Hospital Wesel - Med. II, Wesel, , Germany
Klinikum Wolfsburg - Med. II, Wolfsburg, , Germany
Contact Details
Name: Alexander Stein, Dr.
Affiliation: HOPE - Hämatologisch-onkologische Praxis Eppendorf
Role: PRINCIPAL_INVESTIGATOR
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