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Brief Title: Combination Liposomal Irinotecan and Pembrolizumab For Triple-Negative Breast Cancer (TNBC) With Brain Metastases (BM)
Official Title: Phase II Study of the Combination of Liposomal Irinotecan (Nal-IRI) and Pembrolizumab for Triple-Negative Breast Cancer (TNBC) With Brain Metastases (BM)
Study ID: NCT05255666
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Name: Ashley Frith, M.D.
Affiliation: Washington University School of Medicine
Role: PRINCIPAL_INVESTIGATOR