Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma / Stomach or esophageal cancer that cannot be operated surgery and/or has metastasized.
Conditions
Interventions
Patients will be randomised in 3 different groups in a 1:1:1 ratio.
Group A. The people in this group will get trastuzumab with chemotherapy
(standard of care). Trastuzumab will be given every 3 we
Sponsors
Jazz Pharmaceuticals Ireland Limited
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Prior treatment with a HER2-targeted agent, with the exception of subjects who received HER2-targeted treatment for breast cancer > 5 years prior to initial diagnosis of GEA. 2. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
Exclusion criteria
Exclusion criteria: PRIOR TREATMENT WITH A HER2-TARGETED AGENT, WITH THE EXCEPTION OF SUBJECTS WHO RECEIVED HER2-TARGETED TREATMENT FOR BREAST CANCER > 5*YEARS PRIOR TO INITIAL DIAGNOSIS OF GEA. PRIOR TREATMENT WITH AN ANTI-PD-1, ANTI-PD-L1, ANTI-PD-L2 OR ANY OTHER ANTIBODY OR DRUG SPECIFICALLY TARGETING T-CELL CO-STIMULATION OR CHECKPOINT PATHWAYS. PRIOR TREATMENT WITH SYSTEMIC ANTINEOPLASTIC THERAPY OR INTRAPERITONEAL CHEMOTHERAPY FOR UNRESECTABLE LOCALLY ADVANCED, RECURRENT OR METASTATIC GEA. SUBJECTS WHO HAVE RECEIVED TREATMENT WITH ADJUVANT OR NEOADJUVANT CHEMOTHERAPY OR CHEMORADIOTHERAPY MUST NOT HAVE CANCER RECURRENCE OR PROGRESSION WITHIN 6*MONTHS OF COMPLETING THAT THERAPY. SUBJECTS WHO HAVE RECEIVED PRIOR PALLIATIVE LOCAL THERAPY (E.G., RADIATION THERAPY) ARE ELIGIBLE. RECEIVED RADIATION THERAPY WITHIN 14 DAYS PRIOR TO RANDOMIZATION. TOTAL LIFETIME ANTHRACYCLINE LOAD EXCEEDING 360 MG/M2 DOXORUBICIN OR EQUIVALENT. ANY CONDITION THAT REQUIRES SYSTEMIC TREATMENT WITH EITHER CORTICOSTEROIDS (> 10 MG DAILY OF PREDNISONE OR EQUIVALENT) OR OTHER IMMUNOSUPPRESSIVE MEDICATION =*Grade*3) from the gastrointestinal (GI) tract within 4 weeks prior to randomization. Clinically significant bowel obst
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Progression-free survival (PFS) by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), assessed by blinded independent central review (BICR) - Overall survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Confirmed objective response rate (ORR) by RECIST 1.1, assessed by BICR - Duration of response (DOR) by RECIST 1.1, assessed by BICR - PFS by RECIST 1.1, per investigator assessment - Confirmed ORR by RECIST 1.1, per investigator assessment - DOR by RECIST 1.1, per investigator assessment - Overall survival (OS) - PFS by RECIST 1.1, by BICR - Frequency, type, severity, seriousness, and relatedness of adverse events (AEs) - Frequency and severity of clinical laboratory abnormalities - Change from baseline in health economics and outcomes research / patient-reported outcomes (HEOR/PRO) parameters - Serum concentration and PK parameters for zanidatamab - Serum concentration for tislelizumab - Frequency, duration, and time of onset of anti-zanidatamab antibodies and neutralizing antibodies, if applicable - Frequency, duration, and time of onset of anti-tislelizumab antibodies and neutralizing antibodies, if applicable | — |
Countries
Netherlands
Outcome results
None listed