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PD-L1 Inhibitor

Immunotherapy for Intraductal Carcinoma

Q: What medical ailments is Pembrolizumab employed in the treatment of?

Pembrolizumab is widely used as a treatment for malignant neoplasms. Additionally, this drug can help patients manage unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, microsatellite instability high, and cases of chemotherapy-resistant <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a>.

Q: Is there an ongoing enrollment process for this research trial?

Affirmative. Clinicaltrials.gov data confirms that this medical trial is actively seeking patients, with its first posting on December 12th 2016 and most recent edit occurring on October 21st 2022. The research is recruiting for a cohort of 48 individuals across a single site.

Q: What is the participant count of this research initiative?

Yes, the information provided on clinicaltrials.gov suggests that this medical trial is currently seeking participants. This study was initially posted in December 2016 and recently updated in October 2022; 48 individuals are being targeted from a single site.

Q: Could you elaborate on the precedent set by Pembrolizumab in clinical trials?

To date, 962 trials are being conducted to research the effects of Pembrolizumab; 122 of these live studies have reached Phase 3. With a bulk of them located in Houston, <a href="https://www.withpower.com/clinical-trials/texas">Texas</a>, there is an impressive 35769 sites conducting experiments for this specific course of treatment.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am planning to have surgery to remove my cancer.

Select...

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Changes in Mean Tumor volume

Injections, Intralesional

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

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 2

~2010

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Laura EssermanLead Sponsor

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,503 Total Patients Enrolled

ModernaTX, Inc.Industry Sponsor

107 Previous Clinical Trials

61,378,057 Total Patients Enrolled

Media Library

Pembrolizumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02872025 — Phase < 1

Intraductal Carcinoma Research Study Groups: mRNA-2752 x 2-4 doses with or without immune checkpoint inhibitor (Expansion Cohort), CLOSED:Pembrolizumab IL x 2 doses + mRNA 2752 IL x 2-4 doses (Expansion Phase), CLOSED:Pembrolizumab intralesionally (IL) x 2 doses (Escalation Phase), CLOSED:Pembrolizumab IL x 4 doses (Expansion Phase), mRNA-2752 Monotherapy x 2-4 doses (Escalation Cohort), No active treatment

Intraductal Carcinoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT02872025 — Phase < 1

Pembrolizumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02872025 — Phase < 1

Frequently Asked Questions

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

What medical ailments is Pembrolizumab employed in the treatment of?

"Pembrolizumab is widely used as a treatment for malignant neoplasms. Additionally, this drug can help patients manage unresectable melanoma, microsatellite instability high, and cases of chemotherapy-resistant cancer."

Answered by AI

Is there an ongoing enrollment process for this research trial?

"Affirmative. Clinicaltrials.gov data confirms that this medical trial is actively seeking patients, with its first posting on December 12th 2016 and most recent edit occurring on October 21st 2022. The research is recruiting for a cohort of 48 individuals across a single site."

Answered by AI

What is the participant count of this research initiative?

"Yes, the information provided on clinicaltrials.gov suggests that this medical trial is currently seeking participants. This study was initially posted in December 2016 and recently updated in October 2022; 48 individuals are being targeted from a single site."

Answered by AI

Could you elaborate on the precedent set by Pembrolizumab in clinical trials?

"To date, 962 trials are being conducted to research the effects of Pembrolizumab; 122 of these live studies have reached Phase 3. With a bulk of them located in Houston, Texas, there is an impressive 35769 sites conducting experiments for this specific course of treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Immunotherapy in High-risk Ductal Carcinoma in Situ (DCIS)

Laura Esserman 2016. "Immunotherapy in High-risk Ductal Carcinoma in Situ (DCIS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02872025.

All > Dcis