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

Conditions

• Carcinoma, Intraductal, Noninfiltrating

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab — DRUG
  Injected intralesionally
• Intralesional mRNA 2752 — BIOLOGICAL
  Injected intralesionally

Study Details

This is a study to investigate the change in the immune microenvironment of high risk ductal carcinoma in situ (DCIS) after short term exposure to immunotherapy.

Key Dates

Start date

Dec 12, 2016

Status verified

Jan 2025

Primary completion

Mar 31, 2026

Completion

Mar 31, 2026

Study Design

Enrollment

42 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CLOSED:Pembrolizumab intralesionally (IL) x 2 doses (Escalation Phase)
  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).
• Experimental: CLOSED:Pembrolizumab IL x 4 doses (Expansion Phase)
  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).
• Experimental: CLOSED:Pembrolizumab IL x 2 doses + mRNA 2752 IL x 2-4 doses (Expansion Phase)
  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).
• Experimental: mRNA-2752 Monotherapy x 2-4 doses (Escalation Cohort)
  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
• Experimental: mRNA-2752 x 2-4 doses with or without immune checkpoint inhibitor (Expansion Cohort)
  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 Intervention: No active treatment
  The control group will proceed to surgery alone within a 4 month timeframe following the diagnosis of high risk DCIS.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: 18 months ]

Locations (1)

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