NCT05255666

Combination Liposomal Irinotecan and Pembrolizumab For Triple-Negative Breast Cancer (TNBC) With Brain Metastases (BM)

Phase II Study of the Combination of Liposomal Irinotecan (Nal-IRI) and Pembrolizumab for Triple-Negative Breast Cancer (TNBC) With Brain Metastases (BM)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Triple Negative Breast Cancer
• Brain Metastases

Interventions

Type	Name	Description
DRUG	Pembrolizumab	400 mg intravenously
DRUG	Liposomal Irinotecan	Starting at 50 mg/m\^2. The dose may be increased to 70 mg/m\^2 if tolerated or dose reduced to 35 mg/m\^ if treatment-emergent severe adverse event (TESAE) occurs.

Timeline

• Start date: 2023-07-31
• Primary completion: 2027-01-31
• Completion: 2030-01-31
• First posted: 2022-02-24
• Last updated: 2023-07-11

Regulatory

• FDA-regulated drug study