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Withdrawn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

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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