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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
Be a male or female subject greater than or equal to 18 years of age on day of signing informed consent.
Have locally confirmed TNBC, as defined by the most recent ASCO/CAP guidelines.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up following definitive surgery, approximately 9 months.
Awards & highlights
No Placebo-Only Group

Study 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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I am 18 years or older.
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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.
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I can provide a biopsy sample from my tumor for research.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My organ functions are within normal ranges as per recent tests.
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I am willing to use birth control as required by the study.

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 2021 Phase 3 trial • 453 Patients • NCT03066778
54%
Neutropenia
45%
Anaemia
38%
Nausea
34%
Alopecia
31%
Decreased appetite
29%
Constipation
27%
Fatigue
26%
Thrombocytopenia
22%
Leukopenia
21%
Diarrhoea
20%
Cough
17%
Asthenia
17%
Dyspnoea
16%
Vomiting
14%
Pyrexia
14%
Dizziness
13%
Headache
13%
Arthralgia
13%
Rash
12%
Hypothyroidism
11%
Pruritus
11%
Insomnia
11%
Back pain
10%
Weight decreased
9%
Hyponatraemia
9%
Aspartate aminotransferase increased
8%
Upper respiratory tract infection
8%
Pneumonia
8%
Oedema peripheral
8%
Alanine aminotransferase increased
7%
Hypokalaemia
7%
Febrile neutropenia
7%
Abdominal pain
7%
Blood creatinine increased
6%
Abdominal pain upper
6%
Stomatitis
6%
Dry skin
6%
Erythema
6%
Dysgeusia
5%
Nasopharyngitis
5%
Hyperthyroidism
5%
Dyspepsia
5%
Dysphagia
5%
Blood alkaline phosphatase increased
5%
Pain in extremity
5%
Musculoskeletal chest pain
5%
Musculoskeletal pain
5%
Chest pain
5%
Hypertension
4%
Hypotension
4%
Urinary tract infection
2%
Atrial fibrillation
2%
Pulmonary embolism
2%
Death
2%
Acute kidney injury
2%
Pneumonitis
1%
Hemiparesis
1%
Clostridium difficile colitis
1%
Neutropenic sepsis
1%
Pleural infection
1%
Sepsis
1%
Infusion related reaction
1%
Diabetes mellitus
1%
Aortic aneurysm
1%
Inappropriate antidiuretic hormone secretion
1%
Pneumothorax
1%
Transient ischaemic attack
1%
Gastritis
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab+EP
Placebo+EP
Pembrolizumab Second Course

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~2050
IRX 2
2019
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Providence Health & ServicesLead Sponsor
115 Previous Clinical Trials
122,544 Total Patients Enrolled
6 Trials studying Breast Cancer
4,596 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,844 Previous Clinical Trials
5,045,883 Total Patients Enrolled
57 Trials studying Breast Cancer
7,480 Patients Enrolled for Breast Cancer
Brooklyn ImmunoTherapeutics, LLCIndustry Sponsor
7 Previous Clinical Trials
5,468 Total Patients Enrolled

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04373031 — Phase 2
Breast Cancer Research Study Groups: Control, Arm A
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To which illnesses is Pembrolizumab typically prescribed?

"Pembrolizumab is frequently used to help patients with malignant neoplasms, particularly in cases of unresectable melanoma or where chemotherapy has failed. It can also assist those suffering from microsatellite instability high conditions."

Answered by AI

Has Pembrolizumab been evaluated in earlier experiments?

"Currently, there are 964 ongoing studies for pembrolizumab with 122 of them in Phase 3. Primarily based in Houston, TX., this medication has been tested at over 35 thousand locations worldwide."

Answered by AI

Is recruitment for this research endeavor still available?

"This clinical trial, which has been available since the 30th of December 2020 and was last amended on the 31st of January 2022 is actively seeking participants."

Answered by AI

What has been the outcome of regulatory consideration for Pembrolizumab?

"Our team has assigned Pembrolizumab a safety rating of 2, as there is some evidence that it does not pose substantial risk to patients, but data supporting its efficacy in this particular Phase 2 trial remains inconclusive."

Answered by AI

Can you provide an estimate of the total cohort size for this research study?

"Affirmative. Clinicaltrials.gov verifies that this experiment is actively searching for participants; the original post was created on December 30th 2020 and edited most recently on January 31st 2022. The research requires a total of thirty patients from one specified medical site."

Answered by AI
~1 spots leftby Jun 2024