drugset / Trial / NCT05255666
Combination Liposomal Irinotecan and Pembrolizumab For Triple-Negative Breast Cancer (TNBC) With Brain Metastases (BM)
Phase 2
Withdrawn
Washington University School of Medicine
Ipsen · collabMerck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment
Summary
The study is a phase II with safety lead in, single arm, study using Nal-IRI in combination with pembrolizumab. Nal-IRI will be given IV every 2 weeks starting at 50mg/m2. Pembrolizumab will be given 400mg IV every 6 weeks. Treatment will continue until progression, intolerable side effects or patient/doctor decision to discontinue treatment.
Timeline
- Start
- 2023-07-31
- Primary completion
- 2027-01-31
- Completion
- 2030-01-31
Outcome
Outcome not reported
Stopped: “No drug”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 35 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 70 mg/m2 | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 400 mg | Intravenous |