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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up following definitive surgery, approximately 9 months.
Awards & highlights
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 belowSelect...
My breast cancer is triple-negative, confirmed by local testing.
Select...
My triple-negative breast cancer is advanced but hasn't spread beyond the local area.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ following definitive surgery, approximately 9 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~following definitive surgery, approximately 9 months.
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 • 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
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
117 Previous Clinical Trials
822,523 Total Patients Enrolled
6 Trials studying Breast Cancer
4,596 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,541 Total Patients Enrolled
58 Trials studying Breast Cancer
7,522 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had chemotherapy, targeted therapy, and radiation in the last year.My breast cancer is triple-negative, confirmed by local testing.I have been treated with specific immune therapy or participated in MK-3475 trials.Your heart's pumping function is normal, as shown by a recent heart scan.I have had pneumonitis treated with steroids or have it now.I have an active tuberculosis infection.I have an autoimmune disease treated with strong medication in the last 2 years.I am 18 years or older.I have not received a live vaccine in the last 30 days.I have not had cancer, except for certain skin cancers or cervical cancer in situ, in the last 5 years.I have been diagnosed with HIV.I am currently being treated for an infection.I have a serious heart condition.You are allergic to ciprofloxacin or other similar antibiotics.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.You currently have Hepatitis B or Hepatitis C that is active.I am fully active or restricted in physically strenuous activity but can do light work.I am willing to use birth control as required by the study.My organ functions are within normal ranges as per recent tests.My triple-negative breast cancer is advanced but hasn't spread beyond the local area.I can provide a biopsy sample from my tumor for research.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Control
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 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
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