Tests TRK-950 alone and with nivolumab in advanced solid tumors and melanoma
Tests TRK-950, alone or with nivolumab, in adults with advanced cancers.
Plain-language title generated from the registry record
Registry title: A Study of TRK-950 in Patients With Advanced Solid Tumors
Key facts
- Where
- Chuo Ku, Fukuoka, Hidaka, Kumamoto, Matsumoto, Nagaizumi-chō, Nagoya, Niigata, Sapporo, and Shinjuku-ku, JapanSee the 10 sites
- Phase
- Phase 1/2
Where in Japan
- National Cancer Center HospitalChuo Ku, JapanTaking people
- National Hospital Organization Kyushu Cancer CenterFukuoka, JapanTaking people
- Saitama Medical University International Medical CenterHidaka, JapanTaking people
- Kumamoto University HospitalKumamoto, JapanTaking people
- Shinshu University HospitalMatsumoto, JapanTaking people
- Shizuoka Cancer CenterNagaizumi-chō, JapanTaking people
- Nagoya City University HospitalNagoya, JapanTaking people
- Niigata Cancer Center HospitalNiigata, JapanTaking people
- Sapporo Medical University HospitalSapporo, JapanTaking people
- Keio University HospitalShinjuku-ku, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Toray Industries, Inc
- Trial code
- NCT05423262
- Record updated
- 8 October 2026
- Original description
Part 1Read full original descriptionShow less
A Phase I/II Study of TRK-950 in Patients With Advanced Solid Tumors
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
Inclusion: 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).
Exclusion: 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; 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.