Erudio Healtherudio.com
Clinical trial · no report yet · Phase 3
KEYNOTE-361
Study of Pembrolizumab With or Without Platinum-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma (MK-3475-361/KEYNOTE-361)
- NCT02853305 ↗
- Completed
- Merck Sharp & Dohme LLC
- Focused
We haven't built an HCP commentary report on KEYNOTE-361 (pembrolizumab in advanced or metastatic urothelial carcinoma) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on KEYNOTE-361 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 3 |
The trial
ClinicalTrials.gov- Official title
- A Phase III Randomized, Controlled Clinical Trial of Pembrolizumab With or Without Platinum-Based Combination Chemotherapy Versus Chemotherapy in Subjects With Advanced or Metastatic Urothelial Carcinoma
- Phase
- Phase 3
- Status
- Completed
- Conditions
- Urothelial Carcinoma Associated 1 RNA, Human
- Interventions
- Pembrolizumab; Cisplatin; Carboplatin; Gemcitabine
- Arms
- Pembrolizumab + ST Chemotherapy (Pembro Combo) · Experimental
- Pembrolizumab (Pembro) · Experimental
- ST Chemotherapy (Chemo) · Active comparator
- Enrollment
- 1,010
- Primary outcomes
- Pembro Combo vs Chemo: Progression-free Survival (PFS) Using Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
- Pembro Combo vs Chemo: Overall Survival (OS)
- Pembro vs Chemo: OS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10%
- Pembro vs Chemo: OS
- Sponsor
- Merck Sharp & Dohme LLC
- Start
- Sep 15, 2016
- Primary completion
- Apr 29, 2020
- Results posted
- Yes
- Registry record
- NCT02853305 · updated Sep 8, 2023
Publications
linked from the registry- Giannatempo P, Machiels JP, Sassa N, Arranz JA, Fujii Y, Su WP, Keam B, Culine S, Shen YC, Langa JM, Sarid D, Aarts M, Calabro F, Rosenbaum E, Moreno BH, Bavle A, Xu JZ, Rha SY. Impact of Histology on Clinical Outcomes of Pembrolizumab Monotherapy in Patients With Advanced or Metastatic Urothelial Carcinoma in the Phase 3 KEYNOTE-045 and KEYNOTE-361 Trials. Clin Genitourin Cancer. 2025 Apr;23(2):102273. doi: 10.1016/j.clgc.2024.102273. Epub 2024 Nov 15. PubMed 40037029
- Flechon A, Morales-Barrera R, Powles T, Alva A, Ozguroglu M, Csoszi T, Loriot Y, Rodriguez-Vida A, Geczi L, Cheng SY, Fradet Y, Oudard S, Vulsteke C, Gunduz S, Mamtani R, Yu EY, Montesa Pino A, Anido U, Sendur MAN, Gravis G, Revesz J, Kostorov V, Huillard O, Ma J, Rajasagi M, Vajdi A, Lunceford J, Cristescu R, Imai K, Homet Moreno B, Matsubara N. Association of Tumor Mutational Burden and PD-L1 with the Efficacy of Pembrolizumab with or without Chemotherapy versus Chemotherapy in Advanced Urothelial Carcinoma. Clin Cancer Res. 2024 Dec 2;30(23):5353-5364. doi: 10.1158/1078-0432.CCR-23-3518. PubMed 39475359
- Powles T, Chang YH, Yamamoto Y, Munoz J, Reyes-Cosmelli F, Peer A, Cohen G, Yu EY, Lorch A, Bavle A, Homet Moreno B, Markensohn J, Edmondson M, Chen C, Cristescu R, Pena C, Lunceford J, Gunduz S. Pembrolizumab for advanced urothelial carcinoma: exploratory ctDNA biomarker analyses of the KEYNOTE-361 phase 3 trial. Nat Med. 2024 Sep;30(9):2508-2516. doi: 10.1038/s41591-024-03091-7. Epub 2024 Jun 1. PubMed 38823511
- Topp BG, Channavazzala M, Mayawala K, De Alwis DP, Rubin E, Snyder A, Wolchok JD, Ribas A. Tumor dynamics in patients with solid tumors treated with pembrolizumab beyond disease progression. Cancer Cell. 2023 Sep 11;41(9):1680-1688.e2. doi: 10.1016/j.ccell.2023.08.004. PubMed 37699333
- Powles T, Csoszi T, Ozguroglu M, Matsubara N, Geczi L, Cheng SY, Fradet Y, Oudard S, Vulsteke C, Morales Barrera R, Flechon A, Gunduz S, Loriot Y, Rodriguez-Vida A, Mamtani R, Yu EY, Nam K, Imai K, Homet Moreno B, Alva A; KEYNOTE-361 Investigators. Pembrolizumab alone or combined with chemotherapy versus chemotherapy as first-line therapy for advanced urothelial carcinoma (KEYNOTE-361): a randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Jul;22(7):931-945. doi: 10.1016/S1470-2045(21)00152-2. Epub 2021 May 26. PubMed 34051178