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PD-L1 Inhibitor

Immunotherapy for Intraductal Carcinoma

Phase < 1

Recruiting

Led By Laura Esserman, MD

Research Sponsored by Laura Esserman

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Plan on having surgical treatment to remove the lesion

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Must not have

Hypersensitivity to mRNA-2752 for mRNA-2752 monotherapy and combination therapy and hypersensitivity to immune check point inhibitor for the combination therapy or any of its excipients

Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a cancer drug can improve the immune system's response to pre-cancerous cells, which may prevent the cells from turning into cancer.

Who is the study for?

This trial is for adults with high-risk ductal carcinoma in situ (DCIS) who plan to have surgery, are not pregnant or breastfeeding, and agree to use contraception. Eligible participants must have certain high-risk features like a palpable mass or hormone receptor negative status, be in good physical condition (ECOG 0-1), and demonstrate adequate organ function.

What is being tested?

The study tests the effects of short-term immunotherapy on DCIS using Pembrolizumab and Intralesional mRNA 2752 before surgical removal. It aims to understand how these treatments alter the immune environment within the breast tissue affected by cancer.

What are the potential side effects?

Potential side effects may include reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, changes in blood counts leading to increased infection risk or bleeding problems, possible autoimmune responses where the body attacks its own cells, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am planning to have surgery to remove my cancer.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am using two birth control methods or am not able to have children, and will continue for 120 days after my last dose.

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My kidney function is within the required range.

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My breast cancer is aggressive, based on at least 2 high-risk features.

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I am 18 years old or older.

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My liver function tests are within the required range.

Exclusion Criteria

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

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I am not allergic to mRNA-2752 or immune checkpoint inhibitors.

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I have had or currently have lung inflammation treated with steroids.

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My breast cancer is hormone-receptor positive but not HER2 positive.

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I have been diagnosed with HIV.

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I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

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I have an active TB infection.

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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 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

Maximum tolerated dose (MTD)

Number of participants with Dose-limiting toxicities (DLTs)

Percentage of patients who demonstrate an increase (baseline vs. post intralesional injection) in intralesional CD8+ T cells

Other study objectives

Changes in Mean Tumor volume

Injections, Intralesional

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

6Treatment groups

Experimental Treatment

Active Control

Group I: mRNA-2752 x 2-4 doses with or without immune checkpoint inhibitor (Expansion Cohort)Experimental Treatment1 Intervention

Participants will be will be offered injections of mRNA-2752 given on up to 4 occasions, 3 weeks apart (+/- 1 week) or a combination mRNA-2752 and immune checkpoint inhibitor will be given up to 4 occasions, 3 weeks apart (+/- 1 week). The participants will proceed to biopsy, either image guided or excisional or partial mastectomy.

Group II: mRNA-2752 Monotherapy x 2-4 doses (Escalation Cohort)Experimental Treatment1 Intervention

Participants will be offered up to 4 doses of mRNA-2752 injected intralesionally (IL) 3 weeks apart (+/- 1) week) with surgery or core biopsy 3 weeks (+/-1 week). The participants will proceed to biopsy, either image guided or excisional or partial mastectomy

Group III: CLOSED:Pembrolizumab intralesionally (IL) x 2 doses (Escalation Phase)Experimental Treatment1 Intervention

Participants, upon diagnosis with high risk DCIS, will be offered 2 doses of pembrolizumab injected intralesionally (IL) 3 weeks apart (+/- 1 week) with surgery 3 weeks (+/- 2 weeks) after the 2nd dose. The participant will then undergo the surgical treatment as determined by the surgeon and the participant (partial mastectomy or mastectomy).

Group IV: CLOSED:Pembrolizumab IL x 4 doses (Expansion Phase)Experimental Treatment1 Intervention

Participants, upon diagnosis with high risk DCIS, will be offered 4 doses of pembrolizumab injected intralesionally (IL) 3 weeks apart (+/- 1 week) with surgery 3 weeks (+/- 2 weeks) after the 4th dose. The participant will then undergo the surgical treatment as determined by the surgeon and the participant (partial mastectomy or mastectomy).

Group V: CLOSED:Pembrolizumab IL x 2 doses + mRNA 2752 IL x 2-4 doses (Expansion Phase)Experimental Treatment2 Interventions

Participants, upon diagnosis with high risk DCIS, will be offered 2 doses of pembrolizumab and intralesional mRNA 2752 injected intralesionally (IL) 3 weeks apart (+/- 1 week) with surgery 3 weeks (+/- 2 weeks) after the 2nd dose. The participant will then undergo the surgical treatment as determined by the surgeon and the participant (partial mastectomy or mastectomy).

Group VI: No active treatmentActive Control1 Intervention

The control group will proceed to surgery alone within a 4 month timeframe following the diagnosis of high risk DCIS.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 15Eligibility criteria met