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Topoisomerase I inhibitor

Pembrolizumab for Breast Cancer

Phase 2
Waitlist Available
Led By Ashley Frith, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of follow-up (estimated to be 3 years and 6 months)
Awards & highlights

Study Summary

This trial is testing a new combo cancer treatment of Nal-IRI and pembrolizumab. Nal-IRI is given IV every 2 weeks, starting at 50mg/m2, and pembrolizumab is given IV every 6 weeks at 400mg. Treatment will continue until the cancer progresses, the patient has intolerable side effects, or the patient/doctor decides to discontinue treatment.

Eligible Conditions
  • Breast Cancer
  • Brain Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (estimated to be 3 years and 6 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of follow-up (estimated to be 3 years and 6 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Central Nervous System Disease Control Rate (DCR)
Secondary outcome measures
Central Nervous System Objective Response Rate (ORR)
Non-Central Nervous System Objective Response Rate (ORR)
Overall Survival (OS)
+2 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab + Liposomal IrinotecanExperimental Treatment2 Interventions
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Liposomal Irinotecan
2019
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,974 Total Patients Enrolled
59 Trials studying Breast Cancer
7,534 Patients Enrolled for Breast Cancer
IpsenIndustry Sponsor
345 Previous Clinical Trials
73,228 Total Patients Enrolled
3 Trials studying Breast Cancer
56 Patients Enrolled for Breast Cancer
Washington University School of MedicineLead Sponsor
1,933 Previous Clinical Trials
2,299,725 Total Patients Enrolled
47 Trials studying Breast Cancer
5,168 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any enrollments still available for this research project?

"This study is not currently recruiting patients, according to the information posted on clinicaltrials.gov. The study was originally posted on November 30th, 2022 and was last updated on October 17th, 2022. There are 3285 other studies presently looking for patients right now."

Answered by AI

What is the purpose of this clinical trial?

"The primary metric that will be used to measure success after approximately 6 months is the Disease Control Rate. Additionally, the Non-Central Nervous System Objective Response Rate, Overall Survival, and Safety and tolerability as measured by the number of grade 3 and 4 adverse events will be tracked."

Answered by AI

Pembrolizumab - what are the potential risks associated with this treatment?

"There is minimal clinical data supporting Pembrolizumab's safety, but no efficacy data exists yet. Consequently, it received a score of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Combination Liposomal Irinotecan and Pembrolizumab For Triple-Negative Breast Cancer (TNBC) With Brain Metastases (BM)
Cynthia Ma 2023. "Combination Liposomal Irinotecan and Pembrolizumab For Triple-Negative Breast Cancer (TNBC) With Brain Metastases (BM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05255666.
~0 spots leftby Jan 2027
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