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

Sponsor
Washington University School of Medicine
Study ID
NCT05255666
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    400 mg intravenously
  • Liposomal Irinotecan — DRUG
    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.

Study Details

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.

Key Dates

First listed
Feb 24, 2022
Start date
Jul 31, 2023
Status verified
Jul 2023
Primary completion
Jan 31, 2027
Completion
Jan 31, 2030

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab + Liposomal Irinotecan
    * 400 mg of pembrolizumab intravenously on Day 1 of each Cycle (Cycle is 42 days) * 50 mg/m\^2 of liposomal irinotecan (Nal-IRI) intravenously every 2 weeks of each Cycle (Cycle is 42 days)

Primary Outcome Measure

Central Nervous System Disease Control Rate (DCR) [ Time Frame: 6 months ]

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