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Cancer Vaccine
Dendritic Cell Immunotherapy for Triple Negative Breast Cancer
Phase 2
Waitlist Available
Led By Shipra Gandhi
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 2 target lesions present per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at least one of which is amenable to biopsy and injection
Age >= 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment for patients with triple negative breast cancer that has spread or can't be removed by surgery. The treatment boosts the immune system to recognize and destroy cancer cells.
Who is the study for?
This trial is for adults with triple negative breast cancer that has spread or can't be surgically removed. Participants need at least two target lesions, normal liver and blood function, and must use birth control if of child-bearing potential. Exclusions include active infections, certain heart conditions, immunodeficiency disorders, recent vaccine administration, and brain metastases.Check my eligibility
What is being tested?
The trial tests a combination of dendritic cell-based treatment to boost the immune system's ability to fight cancer cells and pembrolizumab—an immune checkpoint inhibitor—to potentially enhance this effect. The goal is to see if these treatments together can reduce symptoms and improve life quality in patients.See study design
What are the potential side effects?
Possible side effects may include reactions related to the immune system such as flu-like symptoms, fatigue, skin reactions; organ inflammation; increased risk of infection; allergic responses to pembrolizumab components; plus any discomfort from procedures like leukapheresis (white blood cell removal) or biopsies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have at least 2 tumors that can be measured and one can be biopsied.
Select...
I am 18 years old or older.
Select...
My breast cancer cannot be surgically removed, has spread, and cannot be cured.
Select...
I have PD-L1 negative triple-negative breast cancer and haven't received first-line treatment for its metastatic stage.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My kidney function, measured by creatinine levels, is within the normal range or slightly above.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Heart rate
Secondary outcome measures
Objective response rate
Overall survival (OS)
Progression-free survival (PFS)
Other outcome measures
Dentatorubral-Pallidoluysian Atrophy
Quality of Life as measured by the Perceived Stress Scale
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
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: Treatment (ST-alpha-DC1, pembrolizumab)Experimental Treatment6 Interventions
Patients undergo leukapheresis over 90 minutes. Patients then receive ST-alpha-DC1 IT on days 1, 8, and 50 in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV on days 8, 29, 50, and 71 in the absence of disease progression or unacceptable toxicity. Patients who are receiving clinical benefit from treatment at the end of day 85, may continue to receive pembrolizumab IV every 3 weeks beyond the 4 study doses. Patients also undergo tumor biopsies on days 1, 8, and 50 and CT scans at baseline and days 50 and 85.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Biopsy
2014
Completed Phase 4
~1090
Leukapheresis
2016
Completed Phase 2
~690
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,839 Total Patients Enrolled
10 Trials studying Breast Cancer
1,638 Patients Enrolled for Breast Cancer
Shipra GandhiPrincipal InvestigatorRoswell Park Cancer Institute
4 Previous Clinical Trials
69 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I had radiotherapy over 2 weeks ago, recovered from side effects, and didn't have lung inflammation from it.I haven't taken strong immune system suppressants or high-dose steroids in the last 3 weeks.I have stable brain metastases and haven't needed steroids for 14 days.I have at least 2 tumors that can be measured and one can be biopsied.Your AST and ALT levels in your blood are not too high. If you have liver metastases, your ALT levels should not be more than five times the normal limit.I am currently being treated for an infection.I have an active HIV infection.I have or had lung inflammation that needed steroids.You currently have Hepatitis B or Hepatitis C virus in your body.I have not had a heart attack or severe heart issue in the last 3 months.I am 18 years old or older.Your hemoglobin level is at least 8 grams per deciliter.My breast cancer cannot be surgically removed, has spread, and cannot be cured.Your bilirubin levels should not be higher than a certain number to be eligible for the study.You have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.I have PD-L1 negative triple-negative breast cancer and haven't received first-line treatment for its metastatic stage.You have enough platelets in your blood.You have a current autoimmune disease or have had an organ transplant in the past.I can take care of myself and am up and about more than half of my waking hours.Your ANC (a type of white blood cell) count must be at least 1500 per microliter of blood.My kidney function, measured by creatinine levels, is within the normal range or slightly above.My triple-negative breast cancer is either PD-L1 positive or negative, and I am seeking treatment beyond the first line.My heart condition severely limits my daily activities.I have not received a live vaccine within the last 30 days.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ST-alpha-DC1, pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent could Pembrolizumab be harmful to individuals?
"Our team at Power estimates that the safety of Pembrolizumab is a 2, as there is limited data available regarding efficacy and more established evidence in terms of its security."
Answered by AI
Are there any vacancies available to partake in this clinical trial?
"Clinicaltrials.gov records suggest that this medical research is not accepting participants, with the initial posting occurring on December 7th 2022 and the most recent update being November 11th 2022. Despite this trial's lack of recruitment at present time, there are 4608 other trials actively recruiting individuals for their studies."
Answered by AI
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