Phase II Study to Confirm Long-Term Safety of ONO-4538 Alone or With Other Treatments in Patients With Various Tumors Continuing ONO-4538 Therapy

What this Trial Is About

This trial is studying participants with various types of tumors who are already being treated with the drug ONO-4538, either alone or combined with other therapies. The main goal is to confirm the long-term safety of ONO-4538 in these patients. The study is open-label and phase II, focusing on patients continuing treatment from previous clinical trials. Participants receive ONO-4538 through intravenous infusion, with doses of either 480 mg every 4 weeks or 240 mg every 2 weeks, as decided by the investigator. Some participants continue combination therapies alongside ONO-4538, including S-1 plus Oxaliplatin, Capecitabine plus Oxaliplatin, Bevacizumab, or Temozolomide, depending on their prior treatment in earlier studies. Throughout the study, patients are monitored for adverse events from the first day of treatment until 28 days after finishing the treatment phase. Researchers track safety by recording any side effects experienced. The study is non-randomized and open-label, and participants remain under medical supervision to assess how they tolerate the ongoing therapy over time.

ONO-4538 Phase II Rollover Study (ONO-4538-98)