Evaluating Pembrolizumab, Trastuzumab and FLOT as Perioperative Treatment of HER2-positive, Localized Esophagogastric Adenocarcinoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

February 13, 2023

Primary Completion Date

October 31, 2027

Study Completion Date

December 31, 2027

Conditions
Esophagogastric Adenocarcinoma
Interventions
DRUG

Pembrolizumab

200 mg flat dose, IV, over 30 minutes; day 1, 22, 43 (8 weeks) pre- and post-surgery, followed by post chemotherapy phase day 1 q3w for 11 cycles; max. 17 applications

DRUG

Trastuzumab

loading dose 8 mg/kg IV over 90 min: day 1 pre- and post-surgery; maintenance dose 6 mg/kg IV over 30 min: Day 22, 43 pre- and post-surgery; followed by 6 mg/kg post chemotherapy phase, day 1 q3w for 11 cycles; max. 17 applications

DRUG

FLOT

Docetaxel 50 mg/m² IV over 1 hour plus Oxaliplatin 85 mg/m² IV over 2 hours plus Folinic Acid 200 mg/m² IV over 1 hour plus 5-FU 2600 mg/m² IV over 24 hours every 2 weeks (day 1, 15, 29, 43) for 8 weeks pre- and 8 weeks post-surgery

Trial Locations (13)

13353

Charité - Universitätsmedizin Berlin / Campus Virchow Klinikum (CVK), Berlin

14195

MVZ Onkologischer Schwerpunkt, Berlin

20249

Hämatologisch-Onkologische Praxis Eppendorf, Hamburg

38440

Klinikum Wolfsburg, Wolfsburg

44649

St. Anna Hospital Herne, Herne

60488

Institut für Klinisch-Onkologische Forschung am Krankenhaus Nordwest, Frankfurt am Main

68167

Tagestherapiezentrum (TTZ) am Interdisziplinären Tumorzentrum (ITM), Mannheim

69120

Nationales Centrum für Tumorerkrankungen, Heidelberg

81675

Klinikum rechts der Isar der TU München, München

89070

Universitätsklinikum Ulm, Ulm

90419

Klinikum Nürnberg, Nuremberg

93049

Krankenhaus Barmherzige Brüder, Regensburg

Unknown

"KEM , Klinik für Internistische Onkologie gGmbH"

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Organon Healthcare GmbH

UNKNOWN

lead

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

OTHER

NCT05504720 - Evaluating Pembrolizumab, Trastuzumab and FLOT as Perioperative Treatment of HER2-positive, Localized Esophagogastric Adenocarcinoma | Biotech Hunter | Biotech Hunter