About this trial
Part 1
• To determine the safety and tolerability of TRK-950 in patients with advanced solid tumors
Part 2
• To determine the safety and tolerability of TRK-950 in combination with nivolumab(NIVO) in patients with advanced solid tumors eligible for NIVO therapy
Part 3
• To determine the efficacy of TRK-950 in patients with advanced/recurrent unresectable melanoma, who received prior chemotherapy with dacarbazine(DTIC) and for whom no standard therapy exists
Eligibility criteria
Qualifiers
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
Disqualifiers
Patients with active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
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
Patients who are positive for human immunodeficiency virus (HIV) antibody
Trial design
Treatments tested in this trial
- TRK-950
- TRK-950
- TRK-950
- Nivolumab
- TRK-950