Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor JPN)
Condition: Solid Tumors
MeSH terms: Neoplasms
Intervention: Avelumab 3 mg/kg; Avelumab 10 mg/kg; Avelumab 20 mg/kg
Intervention description: Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 3 milligrams per kilogram (mg/kg) once every 2 weeks in the dose- escalation cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.; Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 10 mg/kg once every 2 weeks in the dose- escalation cohort and expansion cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.; Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 20 mg/kg once every 2 weeks in the dose- escalation cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.
Intervention MeSH terms: Avelumab; Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Solid Tumors; MSB0010718C; anti PD-L1; avelumab; Phase 1

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