A Phase III Open-label, Multicenter Trial of Avelumab (MSB0010718C) as a Third-line Treatment of Unresectable, Recurrent, or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

JRCT ID: jRCT2080223494

Registered date:29/03/2017

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Unresectable, Recurrent, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
• Date of first enrollment: 02/05/2016
• Target sample size: 330
• Countries of recruitment: Japan,Asia except Japan,North America,South America,Europe,Oceania
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : Avelumab
INN of investigational material : Avelumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Avelumab will be administered as a 1-hour intravenous (IV) infusion at 10 milligram per kilogram (mg/kg) once every 2-week treatment cycle until confirmed progressive disease or unacceptable toxicity along with best supportive care (BSC).

control material(s)
Generic name etc : Irinotecan
INN of investigational material : Irinotecan
Therapeutic category code : 424 Antineoplastic preparations extracted from plants
Dosage and Administration for Investigational material : Irinotecan will be administered at a dose of 150 mg/m ^2 on Day 1 and 15 of a 4-week treatment cycle until disease progression or unacceptable toxicities along with BSC.
Generic name etc : Paclitaxel
INN of investigational material : Paclitaxel
Therapeutic category code : 424 Antineoplastic preparations extracted from plants
Dosage and Administration for Investigational material : Paclitaxel will be administered at a dose of 80 mg/m^2 on Day 1, 8, and 15 of a 4-week treatment cycle until disease progression or unacceptable toxicities along with BSC.
Generic name etc : Best Supportive Care (BSC)
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : BSC is defined as treatment administered with the intent to maximize Quality of life without a specific antineoplastic regimen and is based on investigator's discretion. BSC will be administered once every 3 weeks.

Outcome(s)

Primary Outcome

efficacy
exploratory
Overall Survival [ Time Frame: Time from date of randomization until death, assessed up to 3 years ]

Secondary Outcome

safety
efficacy
exploratory
Progression Free Survival (PFS)
Best Overall Response (BOR)
Change From Baseline in European Quality of Life

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Male or female subjects aged greater than or equal to (>=) 18 years
Subjects with histologically confirmed recurrent unresectable, recurrent locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GEJ)
Availability of a formalin-fixed, paraffin-embedded (FFPE) block containing tumor tissue
Subjects must have received 2 prior courses of systemic treatment for unresectable, recurrent, locally advanced or metastatic gastric cancer, and must have progressed after the second line
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 at trial entry
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

Exclude 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 less than [<] 10 mg prednisone daily).
All subjects with brain metastases, except those meeting the following criteria: a. Brain metastases have been treated locally, and b. No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)
Previous malignant disease (other than gastric cancer) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder,cervical, colorectal, breast)
Prior organ transplantation, including allogeneic stem-cell transplantation Significant acute or chronic infections
Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
Persisting toxicity of grade >2 related to prior therapy except neuropathy and alopecia
Neuropathy Grade greater than or equal (>=) 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

Related Information

• Secondary ID(s): NCT02625623,JapicCTI-173549