A Study of TRK-950 in Patients With Advanced Solid Tumors

Other illness

• Patients with active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
• Patients who are positive for human immunodeficiency virus (HIV) antibody
• Patients who meet any of the following conditions on hepatitis B virus (HBV) and hepatitis C virus (HCV) testing
  • Patients who are positive for hepatitis B surface antigen (HBsAg)
  • Patients who are positive for HCV RNA

Other

• Pregnant women (including those who are considered possibly pregnant based on history taking, etc. by physician) or breastfeeding women (interrupting breastfeeding to enroll is also not allowed)
• Patients who are unwilling or unable to comply with the protocol specified procedures

• Part 1: Patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who have been refractory or intolerant to standard therapies or for whom no standard therapy exists. Part 2: Patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who are eligible for standard therapy with NIVO 240 mg alone administered at 2-week intervals.
• Part 3: Patients with histologically confirmed locally advanced unresectable or metastatic melanoma (excluding uveal melanoma), who received prior chemotherapy with DTIC and for whom no standard therapy exists
• Patients with life expectancy of at least 3 months after the start of study drug administration
• Patients aged \>=18 years at the time of consent
• Patients who are able to provide written consent in person to be a subject of this study
• A negative pregnancy test before enrollment (if female of childbearing potential)