{"preliminary_commentary":{"by_channel":{"x_thread":7},"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":"KEYNOTE-603","nct_id":"NCT03313778","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=keynote-603-nct03313778. 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":"KEYNOTE-603","arms":[{"description":"Participants will receive mRNA-4157 via an intramuscular (IM) injection on Day 1 of each 21-day cycle for up to 9 cycles.","label":"Part A: Dose Escalation and Dose Expansion","type":"EXPERIMENTAL"},{"description":"Participants will receive mRNA-4157 via an IM injection on Day 1 of each 21-day cycle for up to 9 cycles and pembrolizumab via IV infusion on Day 1 of each 21-day cycle until progression, unacceptable toxicity, or up to 35 cycles (approximately 2 years of treatment), whichever is sooner.","label":"Part B: Dose Escalation and Dose Expansion","type":"EXPERIMENTAL"},{"description":"Participants will receive mRNA-4157 via an IM injection on Day 1 of each 21-day cycle and a SoC treatment every 2 weeks (Q2W) on Day 1 of each 21-day cycle starting from Cycle 5 of mRNA-4157 for up to 12 cycles.","label":"Part A2: Dose Expansion","type":"EXPERIMENTAL"},{"description":"Participants will receive mRNA-4157 via IM injection on Day 1 of each 21-day cycle for up to 9 cycles and pembrolizumab via IV infusion on Day 1 of each 21-day cycle until progression, unacceptable toxicity, or up to 35 cycles (approximately 2 years of treatment), whichever is sooner.","label":"Part C: Dose Expansion","type":"EXPERIMENTAL"},{"description":"Participants will receive mRNA-4157 via IM injection on Day 1 of each 21-day cycle for up to 9 cycles and pembrolizumab via IV infusion on Day 1 of each 21-day cycle until progression, unacceptable toxicity, or up to 18 cycles (approximately 1 year of treatment), whichever is sooner.","label":"Part D: Dose Expansion","type":"EXPERIMENTAL"},{"description":"Participants will receive mRNA-4157 via IM injection on Day 1 of each 21-day cycle, pembrolizumab every 6 weeks (Q6W) via IV infusion, and SoC chemotherapy every 3 weeks (Q3W) for up to 4 cycles during the perioperative and adjuvant phases.","label":"Part E1: Dose Expansion","type":"EXPERIMENTAL"},{"description":"Participants will receive mRNA-4157 via IM injection on Day 1 of each 21-day cycle, pembrolizumab Q6W via IV infusion, and SoC chemotherapy Q3W for up to 4 cycles during the perioperative and adjuvant phases.","label":"Part E2: Dose Expansion","type":"EXPERIMENTAL"},{"description":"Participants will receive mRNA-4157 via IM injection on Day 1 of each 21-day cycle, pembrolizumab Q3W via IV infusion, and SoC chemotherapy Q2W or Q3W for up to 4 cycles during the perioperative and adjuvant phases.","label":"Part E3: Dose Expansion","type":"EXPERIMENTAL"}],"collaborators":["Merck Sharp & Dohme LLC"],"completion_date":{"date":"2027-11-21","type":"ESTIMATED"},"conditions":["Solid Tumors"],"enrollment":{"count":161,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"mRNA-4157","otherNames":[],"type":"BIOLOGICAL"},{"name":"Pembrolizumab","otherNames":[],"type":"BIOLOGICAL"},{"name":"SoC Treatment","otherNames":["Standard of care chemotherapy"],"type":"BIOLOGICAL"}],"last_update":"2026-09-03","lead_sponsor":"ModernaTX, Inc.","official_title":"A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2027-11-21","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Number of Participants with Adverse Events","timeFrame":"Part A and A2: Baseline through 100 days after last mRNA-4157 dose; Parts B, C, D, E1, E2, and E3: Baseline through 90 days after last pembrolizumab dose"}],"references":[{"citation":"Berraondo P, Cuesta R, Sanmamed MF, Melero I. Immunogenicity and Efficacy of Personalized Adjuvant mRNA Cancer Vaccines. Cancer Discov. 2024 Nov 1;14(11):2021-2024. doi: 10.1158/2159-8290.CD-24-1196.","pmid":"39485256","type":"DERIVED"}],"start_date":{"date":"2017-08-14","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors","url":"https://clinicaltrials.gov/study/NCT03313778"},"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/keynote-603-nct03313778"}