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Immunomodulator

Pembrolizumab for Breast Cancer

Phase 2
Waitlist Available
Research Sponsored by HiberCell, Inc.
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 within 24 months of last patient enrolled
Awards & highlights

Study Summary

This trial is testing a new cancer treatment for people with metastatic breast cancer who have progressed through other hormone therapies and at most two subsequent chemotherapy treatments. The treatment consists of two drugs, Imprime PGG and pembrolizumab, and the goal is to determine if the overall response rate, as measured by RECIST v1.1, is greater than or equal to 10 patients out of a total of 47 enrolled.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 24 months of last patient enrolled
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 months of last patient enrolled for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Correlate PD-L1 status and changes in the tumor immune microenvironment with treatment outcome
Correlate changes in immune cell activation markers in tumor samples and in peripheral blood immune cells with treatment outcome
Correlate levels of serum anti-β-glucan antibody (ABA) with treatment outcome
+8 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: ExperimentalExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imprime PGG
2014
Completed Phase 2
~160
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

HiberCell, Inc.Lead Sponsor
19 Previous Clinical Trials
854 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,545 Total Patients Enrolled
59 Trials studying Breast Cancer
7,534 Patients Enrolled for Breast Cancer
Alison Stopeck, MDStudy ChairStony Brook University
4 Previous Clinical Trials
174 Total Patients Enrolled
2 Trials studying Breast Cancer
60 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.

How many healthcare institutions are performing research on this clinical trial?

"11 different sites are currently enrolling patients, including Miami Beach, Memphis and Saint Louis Park. To reduce travel expenses it is advised to select the clinic closest to you if joining this trial."

Answered by AI

Are there any openings remaining in this research endeavor for volunteers?

"Correct. According to clinicaltrials.gov, this study is still in the recruitment phase and has been since November 9th 2021. Over 50 individuals are needed from 11 different medical centres for successful completion of the trial."

Answered by AI

What is the aggregate number of individuals participating in this clinical trial?

"Affirmative. The information from clinicaltrials.gov verifies that this investigation is actively recruiting participants, with 50 needed at 11 sites since its initial posting on November 9th 2021 and last edit on the 17th of November 2022."

Answered by AI

What medical conditions typically warrant Pembrolizumab treatments?

"Pembrolizumab is commonly employed in the management of malignant neoplasms. Additionally, it has been demonstrated to be useful when dealing with unresectable melanoma, microsatellite instability high and diseases that have progressed post-chemotherapy administration."

Answered by AI

What experiences have been had with Pembrolizumab in the medical trials arena?

"Currently, 961 trials are being conducted to research Pembrolizumab. Out of these active studies, 122 have advanced to Phase 3. Houston is the major hub for this investigation, yet there are over 35K locations running clinical trials related to pembrozulimab."

Answered by AI

Could you elaborate on the potential hazards of Pembrolizumab treatment?

"Pembrolizumab's safety has been established by prior clinical studies, so it earned a score of 2. This drug is currently in Phase 2 trials and further testing is required to verify its efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase 2 Study of Imprime PGG and Pembrolizumab in Patients With HR+/HER2- Metastatic Breast Cancer (mBCA)
2021. "Phase 2 Study of Imprime PGG and Pembrolizumab in Patients With HR+/HER2- Metastatic Breast Cancer (mBCA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05159778.
~8 spots leftby Apr 2025
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