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

Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study ID
NCT05504720
Phase
PHASE2
Status
Completed

Conditions

  • Esophagogastric Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    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
  • Trastuzumab — DRUG
    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
  • FLOT — DRUG
    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

Study Details

The study is an open-label, single arm, multicenter phase II trial investigating the clinical activity of a perioperative therapy consisting of a combination of pembrolizumab, trastuzumab and FLOT, followed by pembrolizumab plus trastuzumab alone for a maximum systemic treatment duration of one year in patients with Her-2 positive localized esophagogastric adenocarcinoma.

Key Dates

First listed
Aug 17, 2022
Start date
Feb 13, 2023
Status verified
Aug 2026
Primary completion
Jul 15, 2026
Completion
Aug 5, 2026

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab Trastuzumab
    Single arm with pembrolizumab (200 mg flat dose over 30 min IV) on day 1, 22 and 43 plus trastuzumab (loading dose 8 mg/kg IV over 90 min at day 1 and maintenance dose 6 mg/kg IV over 30 min) on day 22 and 43 plus FLOT in four 2-week treatment cycles prior to undergoing surgery. Following surgery, patients will receive four further 2-week cycles of pembrolizumab+trastuzumab + FLOT followed by pembrolizumab (200 mg flat dose) and trastuzumab (6 mg/kg) alone for up to 11 further cycles (Q3W).

Primary Outcome Measure

Disease-free survival after 2 years co-primary endpoint [ Time Frame: 2 years after enrolment ]

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