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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 belowSelect...
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.
Select...
I am using two birth control methods or am not able to have children, and will continue for 120 days after my last dose.
Select...
My kidney function is within the required range.
Select...
My breast cancer is aggressive, based on at least 2 high-risk features.
Select...
I am 18 years old or older.
Select...
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:Select...
I am not allergic to mRNA-2752 or immune checkpoint inhibitors.
Select...
I have had or currently have lung inflammation treated with steroids.
Select...
My breast cancer is hormone-receptor positive but not HER2 positive.
Select...
I have been diagnosed with HIV.
Select...
I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.
Select...
I have an active TB infection.
Select...
I haven't needed systemic treatment for an autoimmune disease in the last 2 years.
Select...
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
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 • NCT0304099964%
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
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
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
~3130
Find a Location
Who is running the clinical trial?
Laura EssermanLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
4,032 Previous Clinical Trials
5,189,733 Total Patients Enrolled
ModernaTX, Inc.Industry Sponsor
121 Previous Clinical Trials
66,785,006 Total Patients Enrolled
Laura Esserman, MD4.03 ReviewsPrincipal Investigator - University of California, San Francisco
University of California, San Francisco
2 Previous Clinical Trials
1,560 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not allergic to mRNA-2752 or immune checkpoint inhibitors.I have had or currently have lung inflammation treated with steroids.My cancer is mostly non-invasive, with less than 10% being invasive.I have stopped taking tamoxifen or aromatase inhibitors at least 2 weeks ago.I am fully active or restricted in physically strenuous activity but can do light work.My organ functions are within normal ranges as per recent tests.I am using two birth control methods or am not able to have children, and will continue for 120 days after my last dose.My kidney function is within the required range.My breast cancer is hormone-receptor positive but not HER2 positive.I have been diagnosed with HIV.I am planning to have surgery to remove my cancer.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I have an active TB infection.I have another cancer besides skin or in situ cervical cancer that needs treatment.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have not received a live vaccine in the last 30 days.My breast cancer is aggressive, based on at least 2 high-risk features.I am 18 years old or older.I am not pregnant or breastfeeding and either cannot become pregnant or will follow birth control guidelines.I agree to use contraception and not donate sperm for at least 210 days after my last treatment dose.I have invasive breast cancer, not just DCIS with less than 10% invasion.My liver function tests are within the required range.
Research Study Groups:
This trial has the following groups:- Group 1: CLOSED:Pembrolizumab IL x 2 doses + mRNA 2752 IL x 2-4 doses (Expansion Phase)
- Group 2: CLOSED:Pembrolizumab intralesionally (IL) x 2 doses (Escalation Phase)
- Group 3: CLOSED:Pembrolizumab IL x 4 doses (Expansion Phase)
- Group 4: mRNA-2752 x 2-4 doses with or without immune checkpoint inhibitor (Expansion Cohort)
- Group 5: mRNA-2752 Monotherapy x 2-4 doses (Escalation Cohort)
- Group 6: No active treatment
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.