Pembrolizumab for Edema

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Edema+12 More
Pembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study how well pembrolizumab works in treating metastatic or recurrent inflammatory breast cancer or triple-negative breast cancer.

Eligible Conditions
  • Edema
  • Estrogen Receptors
  • Recurrent Inflammatory Breast Carcinoma
  • HER2/Neu Negative
  • Peau d'Orange
  • Inflammatory Breast Carcinoma
  • Receptors, Progesterone
  • Erythema
  • Triple Negative Breast Carcinoma

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 3 months post-treatment

Baseline
Biomarker analyses
Month 3
Disease control survival
Overall survival time
Rate of disease control

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Pembrolizumab Second Course
100%Urinary tract infection
100%Parkinsonism
100%Inappropriate antidiuretic hormone secretion
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Urinary tract infection with 100%, Parkinsonism with 100%, Inappropriate antidiuretic hormone secretion with 100%.

Trial Design

1 Treatment Group

Treatment (pembrolizumab)
1 of 1
Experimental Treatment

35 Total Participants · 1 Treatment Group

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Treatment (pembrolizumab)Experimental Group · 2 Interventions: Pembrolizumab, Laboratory Biomarker Analysis · Intervention Types: Biological, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 months post-treatment

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,779 Previous Clinical Trials
1,784,736 Total Patients Enrolled
1 Trials studying Edema
42 Patients Enrolled for Edema
National Cancer Institute (NCI)NIH
12,991 Previous Clinical Trials
41,298,458 Total Patients Enrolled
1 Trials studying Edema
42 Patients Enrolled for Edema
Bora LimPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
95 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have been treated for stage IV or recurrent disease.
You have a performance status of 0-1 on the ECOG performance scale.
You have HER2 negative by IHC or FISH if performed; or HER2 positive by IHC or FISH if not performed.
You have a hemoglobin level of at least 9 g/dL.
Creatinine levels are below the upper limit of normal.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 27th, 2021

Last Reviewed: October 14th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.