{"preliminary_commentary":{"by_channel":{"podcast":1,"x_thread":1,"bluesky_thread":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"name":"NCT02872025","nct_id":"NCT02872025","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct02872025. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"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).","label":"CLOSED:Pembrolizumab intralesionally (IL) x 2 doses (Escalation Phase)","type":"EXPERIMENTAL"},{"description":"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).","label":"CLOSED:Pembrolizumab IL x 4 doses (Expansion Phase)","type":"EXPERIMENTAL"},{"description":"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).","label":"CLOSED:Pembrolizumab IL x 2 doses + mRNA 2752 IL x 2-4 doses (Expansion Phase)","type":"EXPERIMENTAL"},{"description":"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","label":"mRNA-2752 Monotherapy x 2-4 doses (Escalation Cohort)","type":"EXPERIMENTAL"},{"description":"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.","label":"mRNA-2752 x 2-4 doses with or without immune checkpoint inhibitor (Expansion Cohort)","type":"EXPERIMENTAL"},{"description":"The control group will proceed to surgery alone within a 4 month timeframe following the diagnosis of high risk DCIS.","label":"No active treatment","type":"NO_INTERVENTION"}],"collaborators":["Merck Sharp & Dohme LLC","ModernaTX, Inc."],"completion_date":{"date":"2026-03-31","type":"ESTIMATED"},"conditions":["Carcinoma, Intraductal, Noninfiltrating"],"enrollment":{"count":42,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Pembrolizumab","otherNames":["Keytruda","MK-3475"],"type":"DRUG"},{"name":"Intralesional mRNA 2752","otherNames":["mRNA 2752"],"type":"BIOLOGICAL"}],"last_update":"2025-01-30","lead_sponsor":"Laura Esserman","official_title":"Testing the Ability of Immunotherapy to Alter the Tumor Immune MicroEnvionment (TIME) and Reduce or Eradicate High Risk DCIS","overall_status":"ACTIVE_NOT_RECRUITING","phases":["EARLY_PHASE1"],"primary_completion_date":{"date":"2026-03-31","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Maximum tolerated dose (MTD)","timeFrame":"18 months"},{"measure":"Number of participants with Dose-limiting toxicities (DLTs)","timeFrame":"18 months"},{"measure":"Percentage of patients who demonstrate an increase (baseline vs. post intralesional injection) in intralesional CD8+ T cells","timeFrame":"post intralesional injection"}],"references":[{"citation":"Ramalingam K, Woody R, Glencer A, Schwartz CJ, Mori H, Wong J, Hirst G, Rosenbluth J, Onishi N, Gibbs J, Hylton N, Borowsky AD, Campbell M, Esserman LJ. Intratumoral Injection of mRNA-2752 and Pembrolizumab for High-Risk Ductal Carcinoma In Situ: A Phase 1 Nonrandomized Clinical Trial. JAMA Oncol. 2025 Mar 1;11(3):288-292. doi: 10.1001/jamaoncol.2024.5927.","pmid":"39821301","type":"DERIVED"}],"start_date":{"date":"2016-12-12","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Immunotherapy in High-risk Ductal Carcinoma in Situ (DCIS)","url":"https://clinicaltrials.gov/study/NCT02872025"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct02872025"}