avelumab in metastatic or locally advanced solid tumors (javelin solid tumor jpn)

Conditions: Solid Tumors

Summary: this was a phase 1, open-label, dose-escalation trial of avelumab (antibody targeting programmed death ligand 1 \[anti pd-l1\]) in japanese participants with metastatic or locally advanced solid tumors, followed by a consecutive expansion part in asian participants with gastric cancer.


Eligibility criteria:
inclusion criteria: * signed written informed consent * male or female participants aged greater than or equal to (\>=) 20 years * for dose escalation part: histologically or cytologically proven metastatic or locally advanced solid tumors, for which no standard therapy exists or standard therapy has failed * for expansion part: * availability of fresh and archive tumor in formalin fixed paraffin embedded tissue * with histologically or cytologically confirmed recurrent or refractory unresectable stage iv gastric or gastro-esophageal junctional adenocarcinoma (according to american joint committee on cancer/union internationale contre le cancer \[uicc\] 7th edition) and whose disease progressed after one or two prior chemotherapy regimen(s) involving both fluoropyrimidines and platinum * presence of at least 1 measurable lesion according to recist version 1.1 * participants should not have severe peritoneal metastases. the following criteria were applied: * no clinical ileus or subileus * no moderate-to-severe ascites (participants with ascites restricted to the perihepatic space or pelvic cavity) * eastern cooperative oncology group (ecog) performance status of 0 to 1 at the trial entry and an estimated life expectancy of at least 3 months * adequate hematological, hepatic and renal function as defined in the protocol * all participants must agree to use effective means of contraception with their partner from entry into the trial through 6 months after the last dose of avelumab exclusion criteria: * concurrent treatment with a non-permitted drug * prior therapy with any antibody/drug targeting t cell co-regulatory proteins (immune checkpoints) * concurrent anticancer treatment or concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 30 days before the start of trial treatment. short-term administration of steroids (that is, for allergic reactions or the management of immune-related adverse events \[irae\]) is allowed * previous malignant disease within the last 5 years with the exception of adequately treated non-melanoma skin cancer, in situ cancer, or other cancer * non-oncology vaccine therapies for prevention of infection disease (e.g. seasonal flu vaccine, human papilloma virus vaccine) within 4 weeks of study drug administration. vaccination while on study is also prohibited except for administration of the inactivated influenza vaccine. * pregnancy or lactation period * known alcohol or drug abuse * clinically significant (that is, active) cardiovascular disease * all other significant diseases (for example, inflammatory bowel disease), which, in the opinion of the investigator, might impair the participant's tolerance of trial treatment * any psychiatric condition that would prohibit the understanding or rendering of informed consent * legal incapacity or limited legal capacity * other protocol defined exclusion criteria could apply

Keywords: solid tumors msb0010718c anti pd-l1 avelumab phase 1