Study Summary
This trial is testing a new immunization for HER2 positive breast cancer, given with or without pembrolizumab.
- HER2-positive Breast Cancer
- Breast Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 36 months
Trial Safety
Safety Progress
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 13 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Crosby, Erika J., Chaitanya R. Acharya, Anthony-Fayez Haddad, Christopher A. Rabiola, Gangjun Lei, Jun-Ping Wei, Xiao-Yi Yang, et al.. 2020. “Stimulation of Oncogene-specific Tumor-infiltrating T Cells Through Combined Vaccine and Αpd-1 Enable Sustained Antitumor Responses Against Established HER2 Breast Cancer”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-20-0389.
- Crosby EJ, Acharya CR, Haddad AF, Rabiola CA, Lei G, Wei JP, Yang XY, Wang T, Liu CX, Wagner KU, Muller WJ, Chodosh LA, Broadwater G, Hyslop T, Shepherd JH, Hollern DP, He X, Perou CM, Chai S, Ashby BK, Vincent BG, Snyder JC, Force J, Morse MA, Lyerly HK, Hartman ZC. Stimulation of Oncogene-Specific Tumor-Infiltrating T Cells through Combined Vaccine and alphaPD-1 Enable Sustained Antitumor Responses against Established HER2 Breast Cancer. Clin Cancer Res. 2020 Sep 1;26(17):4670-4681. doi: 10.1158/1078-0432.CCR-20-0389. Epub 2020 Jul 30.
- Herbert Lyerly 2019. "A Study to Evaluate Concurrent VRP-HER2 Vaccination and Pembrolizumab for Patients With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03632941.
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
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
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
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
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