At a glance
ClinicalIndex Comparison Record- ✓Histologically and cytologically confirmed locally advanced or metastatic solid tumors refractory/intolerant to standard therapy or no standard therapy exists
- ✓Locally advanced or metastatic solid tumors eligible for NIVO 240 mg alone at 2-week intervals
- ✓Histologically confirmed locally advanced unresectable or metastatic melanoma (excluding uveal melanoma) with prior DTIC chemotherapy and no standard therapy
- ✓Life expectancy of at least 3 months
- ✕Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
- ✕Pregnant or breastfeeding women
- ✕Unwilling or unable to comply with protocol procedures
- ✕Positive for HIV antibody
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Study of TRK-950 in Patients With Advanced Solid Tumors
In Brief
A Phase 2 clinical trial evaluating TRK-950 and Nivolumab for Solid Tumor and Melanoma. Currently recruiting, targeting 49 participants across 10 sites.
Detailed Summary
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
Study Details
Timeline
Interventions
5 or 10 mg/kg administered intravenously over 60 minutes (weekly)
10 mg/kg administered intravenously over 60 minutes (weekly)
20 mg/kg administered intravenously over 60 minutes (bi-weekly)
240 mg administered intravenously over 30 minutes (bi-weekly)
10 mg/kg administered Intravenously over 60 minutes (weekly)