drugset / Trial / NCT04850755
A Phase I Dose Escalation Study of Selinexor Plus Nivolumab and Ipilimumab in Advanced/Metastatic Solid Malignancies
NaSingle-groupOpen-labelTreatment
Summary
This is a single-centre, phase 1a (dose escalation) and 1b (dose expansion) study to evaluate the safety and tolerability of oral Selinexor in combination with nivolumab and ipilimumab in patients with advanced solid malignancies.
Timeline
- Start
- 2021-03-08
- Primary completion
- 2025-03-17
- Completion
- 2025-03-17
Publications
- Results Galon J, Bruni D. Approaches to treat immune hot, altered and cold tumours with combination immunotherapies. Nat Rev Drug Discov. 2019 Mar;18(3):197-218. doi: 10.1038/s41573-018-0007-y.
- Results Tan DS, Bedard PL, Kuruvilla J, Siu LL, Razak AR. Promising SINEs for embargoing nuclear-cytoplasmic export as an anticancer strategy. Cancer Discov. 2014 May;4(5):527-37. doi: 10.1158/2159-8290.CD-13-1005. Epub 2014 Apr 17.
- R Choo J, Jeraj SN, Sundar R, Yong WP, Lee M, Huang Y, Asokumaran Y, Chan GHJ, Ngoi NYL, Wong ALA, Soo RA, Chee CE, Lim JSJ, Goh BC, Lee SC, Tan DSP. NEXUS: a phase I dose escalation study of selinexor plus nivolumab and ipilimumab in Asian patients with advanced/metastatic solid malignancies. Ther Adv Med Oncol. 2025 Jun 9;17:17588359251339930. doi: 10.1177/17588359251339930. eCollection 2025.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | — |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | — |
| Subject | Selinexor | Other / unclassified | 40 mg | Oral |
| Subject | Selinexor | Other / unclassified | 60 mg | Oral |