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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

No Placebo-Only Group

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.

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.

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 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.

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

Treatment Details

Study Objectives

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

Primary study objectives

Pathological Complete Response (pCR) Rate (ypT0/Tis ypN0)

Secondary study objectives

Safety and Tolerability Profile as assessed by tumor infiltrating lymphocytes

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

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

~3150

IRX 2

2019

Completed Phase 1

~20