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Monoclonal Antibodies

Pembrolizumab + IRX-2 + Chemotherapy for Breast Cancer

Phase 2
Waitlist Available
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have locally confirmed TNBC, as defined by the most recent ASCO/CAP guidelines.
Have previously untreated locally advanced non-metastatic (M0) TNBC defined as the following combined primary tumor (T) and regional lymph node (N) staging per the current AJCC Version 8 staging criteria for breast cancer staging criteria as assessed by the investigator based on radiological and/or clinical assessment.
Must not have
Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) or has previously participated in MK-3475 clinical trials.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up following definitive surgery, approximately 9 months.
Awards & highlights

Summary

This trial is testing whether adding the immunotherapy drug pembrolizumab to standard chemotherapy can help treat triple negative breast cancer.

Who is the study for?
This trial is for adults with untreated, non-metastatic triple negative breast cancer (TNBC) who have good performance status and organ function. Participants must not be pregnant, agree to use contraception, and provide a tumor biopsy. Exclusions include recent live vaccines, other cancers within 5 years, past year chemotherapy or radiation therapy, active autoimmune diseases requiring treatment in the last 2 years, HIV or Hepatitis B/C infection.Check my eligibility
What is being tested?
The study tests pembrolizumab combined with chemotherapy and different immunotherapy induction regimens as pre-surgery treatment for TNBC. It's an open-label Phase II trial where patients are openly assigned to treatments to assess clinical response and immune system activity.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as inflammation of organs; infusion-related reactions; fatigue; changes in blood counts leading to increased risk of infections or bleeding; allergic responses; heart issues due to potential cardiotoxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is triple-negative, confirmed by local testing.
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My triple-negative breast cancer is advanced but hasn't spread beyond the local area.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I've had chemotherapy, targeted therapy, and radiation in the last year.
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I have been treated with specific immune therapy or participated in MK-3475 trials.
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I have had pneumonitis treated with steroids or have it now.
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I have an active tuberculosis infection.
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I have an autoimmune disease treated with strong medication in the last 2 years.
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I have been diagnosed with HIV.
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I am currently being treated for an infection.
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I have a serious heart condition.
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I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~following definitive surgery, approximately 9 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and following definitive surgery, approximately 9 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pathological Complete Response (pCR) Rate (ypT0/Tis ypN0)
Secondary outcome measures
Safety and Tolerability Profile as assessed by CTCAE v5.0
Safety and Tolerability Profile as assessed by tumor infiltrating lymphocytes

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%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
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

2Treatment groups
Experimental Treatment
Group I: ControlExperimental Treatment1 Intervention
Control Arm: (Pembro + ACT): Pembrolizumab induction (single-dose 200mg IV), followed by pembrolizumab Q3W + paclitaxel (T) weekly x 4 cycles, followed by pembrolizumab + doxorubicin + cyclophosphamide (AC) Q3W x 4 cycles as neoadjuvant therapy prior to surgery.
Group II: Arm AExperimental Treatment2 Interventions
• Arm A: (Pembro + IRX-2 + ACT): Pembrolizumab (single-dose 200mg IV) + cyclophosphamide (single-dose 300 mg/m2 IV) + IRX-2 induction (1mL SQ x 2 daily, x 10 days), followed by pembrolizumab Q3W + paclitaxel (T) weekly x 4 cycles, followed by IRX-2 re-induction (1mL SQ x 2 daily, x 10 days), followed by pembrolizumab + doxorubicin + cyclophosphamide (AC) Q3W x 4 cycles as neoadjuvant therapy prior to surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
IRX 2
2019
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Brooklyn ImmunoTherapeutics, LLCIndustry Sponsor
7 Previous Clinical Trials
5,468 Total Patients Enrolled
Providence Health & ServicesLead Sponsor
119 Previous Clinical Trials
822,575 Total Patients Enrolled
6 Trials studying Breast Cancer
4,596 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,919 Previous Clinical Trials
5,068,251 Total Patients Enrolled
58 Trials studying Breast Cancer
7,394 Patients Enrolled for Breast Cancer

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04373031 — Phase 2
Breast Cancer Research Study Groups: Arm A, Control
Breast Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04373031 — Phase 2
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04373031 — Phase 2
~3 spots leftby Jul 2025
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