Kurzfassung

This is a multicenter, international, randomized, open-label Phase III trial in subjects with unresectable, recurrent, locally advanced or metastatic adenocarcinoma of the stomach or of the gastroesophageal junction who have failed or relapsed from 2 prior chemotherapeutic regimens administered for the treatment of unresectable, recurrent, locally advanced or metastatic disease.
All subjects in both arms will receive BSC as background therapy. Subjects will receive BSC with either avelumab or...This is a multicenter, international, randomized, open-label Phase III trial in subjects with unresectable, recurrent, locally advanced or metastatic adenocarcinoma of the stomach or of the gastroesophageal junction who have failed or relapsed from 2 prior chemotherapeutic regimens administered for the treatment of unresectable, recurrent, locally advanced or metastatic disease.
All subjects in both arms will receive BSC as background therapy. Subjects will receive BSC with either avelumab or physician’s choice chemotherapy from among a prespecified list of therapeutic options or BSC alone with no active therapy.
Approximately 330 subjects will be randomized, stratified by region (Asia versus non-Asia), in a 1:1 ratio to receive BSC with either avelumab at a dose of 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks or physician’s choice chemotherapy from the following options:
Paclitaxel as monotherapy (80 mg/m2 on Days 1, 8, and 15 of a 4-week treatment cycle)
Irinotecan as monotherapy (150 mg/m2 on Days 1 and 15 of a 4-week treatment cycle)
Subjects who are not deemed eligible to receive Paclitaxel or Irinotecan at the dose and schedule specified above will receive BSC once every 3 weeks.Subjects receiving avelumab plus BSC who have experienced a complete response (CR) should continue to receive avelumab for at least 12 months after confirmation of response and/or until disease progression or unacceptable toxicity.
Subjects receiving physician’s choice chemotherapy plus BSC or BSC alone will receive trial treatment until progressive disease (PD) per RECIST v1.1, significant clinical deterioration (clinical progression), unacceptable toxicity, or if any criterion for withdrawal from the trial or trial treatment is fulfilled. Subjects receiving physician’s choice plus BSC will not be offered to cross over to avelumab plus BSC.
Investigators must specify which of the physician’s choice treatment regimens will be selected prior to randomization.
The primary endpoint of the trial is OS, defined as the time (in months) from randomization to the date of death, regardless of the actual cause of the subject’s death.» weiterlesen» einklappen