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Pembrolizumab · 1 trial · 1 indication
To determine the maximum tolerated dose (MTD), and recommended dose for subsequent expansion cohort, of intralesionally administered pembrolizumab in patients with ductal carcinoma in situ (DCIS) of the breast.
To define the dose-limiting toxicities (DLTs), tolerability, and feasibility of intralesional administration of pembrolizumab in patients with DCIS.
To determine the response rate to intralesional pembrolizumab in patients with DCIS, as measured by an increase (baseline vs. post treatment) in intralesional CD8+ T cells, compared to untreated controls.
| Arm | Type | Description |
|---|---|---|
| CLOSED:Pembrolizumab intralesionally (IL) x 2 doses (Escalation Phase) | EXPERIMENTAL | 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). |
| CLOSED:Pembrolizumab IL x 4 doses (Expansion Phase) | EXPERIMENTAL | 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). |
| CLOSED:Pembrolizumab IL x 2 doses + mRNA 2752 IL x 2-4 doses (Expansion Phase) | EXPERIMENTAL | 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). |
| mRNA-2752 Monotherapy x 2-4 doses (Escalation Cohort) | EXPERIMENTAL | 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 |
| mRNA-2752 x 2-4 doses with or without immune checkpoint inhibitor (Expansion Cohort) | EXPERIMENTAL | 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. |
| No active treatment | NO_INTERVENTION | The control group will proceed to surgery alone within a 4 month timeframe following the diagnosis of high risk DCIS. |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab | DRUG | Injected intralesionally |
| Intralesional mRNA 2752 | BIOLOGICAL | Injected intralesionally |
Inclusion Criteria: 1. Plan on having surgical treatment to remove the lesion 2. Have at least 2 of the following high-risk features associated with DCIS - high-grade (grade II-III), palpable mass, hormone receptor negative (less than 1%), Her2 positive, young age (less than 45 years old), and larg...
Pembrolizumab is being studied for the treatment of Carcinoma, Intraductal, Noninfiltrating, also known as ductal carcinoma in situ (DCIS). It is currently in early Phase 1 clinical development for this indication, with an active clinical trial evaluating its use in high-risk DCIS patients.
Pembrolizumab targets PDCD1, which encodes the programmed cell death protein 1 (PD-1) receptor. As an inhibitor of PDCD1, it is designed to block the PD-1 pathway, a mechanism being investigated in the context of oncology for the treatment of ductal carcinoma in situ.
Pembrolizumab is being developed by Moderna, Inc., a company publicly traded under the ticker MRNA. The drug is currently in Phase 1 clinical development for the oncology indication of Carcinoma, Intraductal, Noninfiltrating.
Pembrolizumab is in Phase 1 clinical development. Specifically, it is being evaluated in an early Phase 1 clinical trial for the treatment of Carcinoma, Intraductal, Noninfiltrating, also referred to as ductal carcinoma in situ. The drug is investigational and not yet approved for this use.
Pembrolizumab is being studied in clinical trial NCT02872025, titled 'Immunotherapy in High-risk Ductal Carcinoma in Situ (DCIS)'. This early Phase 1 trial is active but not recruiting, with an enrollment of 42 female participants aged 18 years and older in the United States.