Unresectable, recurrent, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma MedDRA version: 20.1 Level: PT Classification code 10017758 Term: Gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10066354 Term: Adenocarcinoma of the gastroesophageal junction System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and poly
Conditions
Sponsors
Merck KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ?Male or female subjects aged = 18 years ?Subjects with histologically confirmed unresectable, recurrent, locally advanced or metastatic adenocarcinoma of the stomach or GEJ ?ECOG PS of 0 to 1 at trial entry ?Estimated life expectancy of more than 12 weeks ?Adequate hematological, hepatic and renal functions defined by the protocol ?Negative blood pregnancy test at Screening for women of childbearing potential. ?Highly effective contraception for both male and female subjects if the risk of conception exists ?Other protocol defined criteria could apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 225 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 105
Exclusion criteria
Exclusion criteria: ?Prior therapy with any antibody or drug targeting T-cell coregulatory proteins ?Concurrent anticancer treatment ?Major surgery ?Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to 3. ?Pregnancy or lactation ?Known alcohol or drug abuse ?History of uncontrolled intercurrent illness including hypertension, active infection, diabetes ?Clinically significant (i.e., active) cardiovascular disease ?All other significant diseases might impair the subject’s tolerance of trial treatment ?Any psychiatric condition that would prohibit the understanding or rendering of informed consent and that would limit compliance with study requirements ?Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines ?Legal incapacity or limited legal capacity ?Subjects will be excluded from the treatment with irinotecan or paclitaxel monotherapy if administration of their chemotherapy would be inconsistent with the current local labeling (for example, in regard to contraindications, warnings/precautions, or special provisions) for that chemotherapy. Investigators should check updated labeling via relevant websites before randomization. ?Subjects should start treatment administration within 28 days after signing the informed consent form (ICF). Treatment administration will start within 4 days after the randomization call. ?Other protocol defined criteria could apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate superiority with regard to overall survival (OS) of avelumab plus best supportive care (BSC) versus physician’s choice (chosen from a pre-specified list of therapeutic options) plus BSC.;Secondary Objective: • To compare avelumab plus BSC versus physician’s choice plus BSC in regard to the following: a.Progression-free survival based on an Independent Review Committee (IRC) assessment b.ORR based on IRC assessment c.Subject-reported outcomes/quality of life (QoL) using the European Quality of Life (EuroQOL) 5-dimensions and 5-levels questionnaire (EQ 5D-5L), and the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and module QLQ STO22. • To determine the safety and tolerability of avelumab.;Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: Analysis of the primary endpoint will occur after 256 events (deaths) have been observed and a minimum of 6 months follow-up since the last subject randomized. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Progression Free Survival (PFS) 2. Best Overall Response (BOR) 3. Change from baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire 4. Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status 5. Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC STO22) Questionnaire Scores;Timepoint(s) of evaluation of this end point: Analysis will occur 256 events (deaths) have been observed and a minimum of 6 months follow-up since the last subject randomized. | — |
Countries
Australia, Belgium, Chile, Colombia, Czech Republic, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Poland, Romania, Russian Federation, Spain, Taiwan, United States
Contacts
Public ContactCommunication Center Merck KGaA
Merck KGaA
Outcome results
None listed