Pembrolizumab for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Duke University, Durham, NCBreast Cancer+1 MorePembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new immunization for HER2 positive breast cancer, given with or without pembrolizumab.

Eligible Conditions
  • HER2-positive Breast Cancer
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 36 months

24 months
Number of Tumor infiltrating Lymphocytes and HER2 specific antibodies
Rate and severity of Adverse Events
36 months
Clinical response rate

Trial Safety

Safety Progress

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

Trial Design

3 Treatment Groups

VRP-HER2 Vaccine
1 of 3
Pembrolizumab
1 of 3
VRP-HER2 Vaccine + Pembrolizumab
1 of 3

Active Control

Experimental Treatment

39 Total Participants · 3 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

VRP-HER2 Vaccine + PembrolizumabExperimental Group · 2 Interventions: Pembrolizumab, VRP-HER2 · Intervention Types: Biological, Biological
VRP-HER2 Vaccine
Biological
ActiveComparator Group · 1 Intervention: VRP-HER2 · Intervention Types: Biological
Pembrolizumab
Biological
ActiveComparator Group · 1 Intervention: Pembrolizumab · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months

Who is running the clinical trial?

Herbert LyerlyLead Sponsor
4 Previous Clinical Trials
162 Total Patients Enrolled
1 Trials studying Breast Cancer
18 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,711 Previous Clinical Trials
4,967,469 Total Patients Enrolled
53 Trials studying Breast Cancer
7,144 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 13 Total Inclusion Criteria

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Frequently Asked Questions

Could you provide a summary of any prior investigations involving Pembrolizumab?

"Currently, 961 clinical trials are ongoing for Pembrolizumab with 122 studies at Phase 3. Houston has a concentration of sites operating these tests; however, 35728 different locations have active research initiatives for this drug." - Anonymous Online Contributor

Unverified Answer

Has Pembrolizumab acquired official sanction from the FDA?

"Our evaluations rank pembrolizumab's safety as a 2 since it is only in Phase 2 of the clinical trial process. This implies that while there are some data confirming its security, none prove efficacy yet." - Anonymous Online Contributor

Unverified Answer

How many participants are currently taking part in this experiment?

"Affirmative. Clinical trials data confirms that this research endeavor, which was initially published on March 1st 2019, is currently seeking participants. This study requires 39 individuals to be enrolled from a single medical site." - Anonymous Online Contributor

Unverified Answer

In what clinical scenarios is Pembrolizumab generally prescribed?

"For the treatment of malignant neoplasms, Pembrolizumab is often employed. Additionally, this drug can be helpful for unresectable melanomas, microsatellite instability high cases and patients with chemotherapy-resistant progression." - Anonymous Online Contributor

Unverified Answer

Are there any opportunities for individuals to join this research endeavor?

"Indeed, the clinicaltrials.gov website reveals that this medical trial is actively recruiting individuals. It was initially launched on March 1st 2019 and updated as recently as December 4th 2021. There are 39 slots available for patients at a single site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.