{"preliminary_commentary":{"by_channel":{"x_thread":4},"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,"drugs_tested":[["pembrolizumab","GVD"]],"indication":"relapsed or refractory classical Hodgkin lymphoma","name":"NCT03618550","nct_id":"NCT03618550","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03618550. 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":"Initially, 6 patients will be treated on the safety portion of the study and observed for dose limiting toxicities (DLTs). If 1 or fewer patients experience dose\\[1\\]limiting toxicity (DLT), enrollment onto the study will proceed according to a phase II, Simon 2- stage design.","label":"Safety Window and DLT definition (Part 1)","type":"EXPERIMENTAL"},{"description":"During the phase II portion of the study, patients will continue to be monitored for DLTs, adverse events, and events of interest throughout treatment with pembrolizumab-GVD, ASCT (part 1, if applicable), and 100 days following the last dose of pembrolizumab. Total planned enrollment is 39 patients","label":"Safety monitoring beyond after completion of safety window (PART 1)","type":"EXPERIMENTAL"},{"description":"Stem cell mobilization and collection will be performed as per institutional guidelines after 2-4 cycles of pembrolizumab-GVD.","label":"Autologous Stem Cell Transplant (ASCT) (PARTS 1 and 3)","type":"EXPERIMENTAL"},{"description":"In part 2 of the study, patients who achieve complete response after 4 cycles of pembrolizumab\\[1\\]GVD will receive single-agent pembrolizumab for 13 cycles, which will begin 3-5 weeks after cycle 4 of pembrolizumab-GVD.","label":"Pembrolizumab maintenance (PART 2)","type":"EXPERIMENTAL"},{"description":"In part 3 of the study, patients who achieve complete response after 2 cycles of pembrolizumab\\[1\\]GVD will be randomized to either consolidation with autologous stem cell transplant (after an additional optional 1-2 cycles of pembro-GVD) or 2 cycles of pembro-GVD followed by single agent pembrolizumab maintenance for 13 cycles.","label":"Pembrolizumab maintenance, third-line therapy, and HDT/ASCT (PART 3A)","type":"EXPERIMENTAL"},{"description":"Patients with limited sites of disease prior to initiation of pembro-GVD are eligible to receive ISRT prior to ASCT with pembrolizumab maintenance.","label":"Involved-site radiation therapy (ISRT) (PART 3B)","type":"EXPERIMENTAL"}],"collaborators":["Merck Sharp & Dohme LLC"],"completion_date":{"date":"2027-08","type":"ESTIMATED"},"conditions":["Hodgkin Lymphoma","Relapsed or Refractory Hodgkin Lymphoma"],"enrollment":{"count":257,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"pembrolizumab","otherNames":[],"type":"DRUG"},{"name":"gemcitabine","otherNames":[],"type":"DRUG"},{"name":"vinorelbine","otherNames":[],"type":"DRUG"},{"name":"liposomal doxorubicin","otherNames":[],"type":"DRUG"},{"name":"Stem cell mobilization and collection","otherNames":[],"type":"PROCEDURE"},{"name":"Involved-site radiation therapy","otherNames":[],"type":"RADIATION"}],"last_update":"2026-10-23","lead_sponsor":"Memorial Sloan Kettering Cancer Center","official_title":"Phase II Study of Second-line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma","overall_status":"RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2027-08","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Complete response rate (part 1)","timeFrame":"2 years"},{"measure":"Assess freedom from disease at 5 years (part 3)","timeFrame":"5 years"}],"references":[{"citation":"Moskowitz AJ, Shah G, Schoder H, Ganesan N, Drill E, Hancock H, Davey T, Perez L, Ryu S, Sohail S, Santarosa A, Galasso N, Neuman R, Liotta B, Blouin W, Kumar A, Lahoud O, Batlevi CL, Hamlin P, Straus DJ, Rodriguez-Rivera I, Owens C, Caron P, Intlekofer AM, Hamilton A, Horwitz SM, Falchi L, Joffe E, Johnson W, Lee C, Palomba ML, Noy A, Matasar MJ, Pongas G, Salles G, Vardhana S, Sanin BW, von Keudell G, Yahalom J, Dogan A, Zelenetz AD, Moskowitz CH. Phase II Trial of Pembrolizumab Plus Gemcitabine, Vinorelbine, and Liposomal Doxorubicin as Second-Line Therapy for Relapsed or Refractory Classical Hodgkin Lymphoma. J Clin Oncol. 2021 Oct 1;39(28):3109-3117. doi: 10.1200/JCO.21.01056. Epub 2021 Jun 25.","pmid":"34170745","type":"BACKGROUND"},{"citation":"Ma S, Spinner MA. Optimizing the Role of Checkpoint Inhibitors in the Management of Hodgkin Lymphoma. J Natl Compr Canc Netw. 2026 Feb;24(2):e257125. doi: 10.6004/jnccn.2025.7125.","pmid":"41698326","type":"DERIVED"}],"start_date":{"date":"2018-08-01","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma","url":"https://clinicaltrials.gov/study/NCT03618550"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03618550"}