MedTrace Logo

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

NCT05255666 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-07-11

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Ashley Frith, M.D. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-31
Primary Completion
2027-01-31
Completion
2030-01-31
FDA Drug
Yes

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05255666 on ClinicalTrials.gov