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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

Must not have

Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug

Participants currently treated with systemic immunosuppressive agents, including steroids (> than equivalent of 10 mg daily of prednisone) are ineligible until 3 weeks after removal from immunosuppressive treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I have at least 2 tumors that can be measured and one can be biopsied.

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I am 18 years old or older.

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My breast cancer cannot be surgically removed, has spread, and cannot be cured.

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I have PD-L1 negative triple-negative breast cancer and haven't received first-line treatment for its metastatic stage.

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I can take care of myself and am up and about more than half of my waking hours.

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My kidney function, measured by creatinine levels, is within the normal range or slightly above.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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I haven't taken strong immune system suppressants or high-dose steroids in the last 3 weeks.

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I am currently being treated for an infection.

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I have an active HIV infection.

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I have or had lung inflammation that needed steroids.

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I have not had a heart attack or severe heart issue in the last 3 months.

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My heart condition severely limits my daily activities.

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I have not received a live vaccine within the last 30 days.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Heart rate

Secondary study objectives

Objective response rate

Overall survival (OS)

Progression-free survival (PFS)

Other study objectives

Dentatorubral-Pallidoluysian Atrophy

Quality of Life as measured by the Perceived Stress Scale

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Biopsy

2014

Completed Phase 4

~1150

Computed Tomography

2017

Completed Phase 2

~2790