{"preliminary_commentary":{"by_channel":{"youtube":32,"podcast":24,"x_thread":15,"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03914612\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"name":"NRG-GY018","nct_id":"NCT03914612","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nrg-gy018-nct03914612. 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"COMBINATION PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.\n\nPatients undergo CT scan throughout the study.\n\nOn February 6, 2023, all patient treatment assignments were unblinded. Patients randomized to Arm 1 will not receive additional placebo infusions.","label":"Arm I (placebo, paclitaxel, carboplatin)","type":"ACTIVE_COMPARATOR"},{"description":"COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE PHASE: Patients receive pembrolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.\n\nPatients undergo CT scan throughout the study.","label":"Arm II (pembrolizumab, paclitaxel, carboplatin)","type":"EXPERIMENTAL"}],"collaborators":["Canadian Cancer Trials Group","NRG Oncology"],"completion_date":{"date":"2027-09-26","type":"ESTIMATED"},"conditions":["Endometrial Clear Cell Adenocarcinoma","Endometrial Dedifferentiated Carcinoma","Endometrial Endometrioid Adenocarcinoma","Endometrial Mixed Cell Adenocarcinoma","Endometrial Serous Adenocarcinoma","Endometrial Undifferentiated Carcinoma","Recurrent Endometrial Adenocarcinoma","Recurrent Endometrial Carcinoma","Recurrent Endometrial Clear Cell Adenocarcinoma","Recurrent Endometrial Dedifferentiated Carcinoma","Recurrent Endometrial Endometrioid Adenocarcinoma","Recurrent Endometrial Mixed Cell Adenocarcinoma","Recurrent Endometrial Serous Adenocarcinoma","Recurrent Endometrial Undifferentiated Carcinoma","Stage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8"],"enrollment":{"count":813,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Carboplatin","otherNames":["Blastocarb","Carboplat","Carboplatin Hexal","Carboplatino","Carboplatinum","Carbosin","Carbosol","Carbotec","CBDCA","Displata","Ercar","JM-8","JM8","Nealorin","Novoplatinum","Paraplatin","Paraplatin AQ","Paraplatine","Platinwas","Ribocarbo"],"type":"DRUG"},{"name":"Computed Tomography","otherNames":["CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","Diagnostic CAT Scan","Diagnostic CAT Scan Service Type","tomography"],"type":"PROCEDURE"},{"name":"Paclitaxel","otherNames":["Anzatax","Asotax","Bristaxol","Praxel","Taxol","Taxol Konzentrat"],"type":"DRUG"},{"name":"Pembrolizumab","otherNames":["BCD-201","GME 751","GME751","Keytruda","Lambrolizumab","MK 3475","MK-3475","MK3475","Pembrolizumab Biosimilar BCD-201","Pembrolizumab Biosimilar GME751","Pembrolizumab Biosimilar QL2107","Pembrolizumab Biosimilar RPH-075","Pembrolizumab Biosimilar SB27","QL2107","RPH 075","RPH-075","RPH075","SB 27","SB-27","SB27","SCH 900475","SCH-900475","SCH900475"],"type":"BIOLOGICAL"},{"name":"Placebo Administration","otherNames":[],"type":"OTHER"},{"name":"Quality-of-Life Assessment","otherNames":["Quality of Life Assessment"],"type":"OTHER"},{"name":"Questionnaire Administration","otherNames":[],"type":"OTHER"}],"last_update":"2026-10-21","lead_sponsor":"National Cancer Institute (NCI)","official_title":"A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC #776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2022-12-16","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free Survival (PFS)","timeFrame":"Duration of time from study entry to time of progression per RECIST criteria or death due to any cause, whichever occurs first. The interquartile range for follow-up was (6.37 months, 30.62 months). The maximum for follow-up was 37.85 months."}],"references":[{"citation":"Eskander RN, Sill MW, Beffa L, Moore RG, Hope JM, Musa FB, Mannel RS, Shahin MS, Cantuaria GH, Girda E, Lokich E, Kavecansky J, Leath CA 3rd, Gien LT, Hinchcliff EM, Lele SB, Landrum LM, Backes F, O'Cearbhaill RE, Baghdadi TA, Hill EK, Thaker PH, John VS, Welch S, Fader AN, Powell MA, Aghajanian C. Pembrolizumab plus chemotherapy in advanced or recurrent endometrial cancer: overall survival and exploratory analyses of the NRG GY018 phase 3 randomized trial. Nat Med. 2025 May;31(5):1539-1546. doi: 10.1038/s41591-025-03566-1. Epub 2025 Mar 5.","pmid":"40044930","type":"DERIVED"},{"citation":"Bogani G, Monk BJ, Powell MA, Westin SN, Slomovitz B, Moore KN, Eskander RN, Raspagliesi F, Barretina-Ginesta MP, Colombo N, Mirza MR. Adding immunotherapy to first-line treatment of advanced and metastatic endometrial cancer. Ann Oncol. 2024 May;35(5):414-428. doi: 10.1016/j.annonc.2024.02.006. Epub 2024 Feb 29.","pmid":"38431043","type":"DERIVED"},{"citation":"Morton M, Marcu I, Levine M, Cosgrove C, Backes F, O'Malley D, Chambers L. Evaluation of Efficacy and Adverse Events After Second Immunotherapy Exposure in Endometrial and Cervical Carcinoma. Obstet Gynecol. 2023 Aug 1;142(2):360-363. doi: 10.1097/AOG.0000000000005243. Epub 2023 Jul 5.","pmid":"37411031","type":"DERIVED"},{"citation":"Eskander RN, Sill MW, Beffa L, Moore RG, Hope JM, Musa FB, Mannel R, Shahin MS, Cantuaria GH, Girda E, Mathews C, Kavecansky J, Leath CA 3rd, Gien LT, Hinchcliff EM, Lele SB, Landrum LM, Backes F, O'Cearbhaill RE, Al Baghdadi T, Hill EK, Thaker PH, John VS, Welch S, Fader AN, Powell MA, Aghajanian C. Pembrolizumab plus Chemotherapy in Advanced Endometrial Cancer. N Engl J Med. 2023 Jun 8;388(23):2159-2170. doi: 10.1056/NEJMoa2302312. Epub 2023 Mar 27.","pmid":"36972022","type":"DERIVED"}],"start_date":{"date":"2019-08-22","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer","url":"https://clinicaltrials.gov/study/NCT03914612"},"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/nrg-gy018-nct03914612"}