Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02872025 | Immunotherapy in High-risk Ductal Carcinoma in Situ (DCIS) | EARLY_PHASE1 | ACTIVE NOT_RECRUITING | 42 | — | — | Dec 12, 2016 | Mar 31, 2026 | Jan 30, 2025 | 1 | United States |
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...