NCT02603432

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

Official title

A PHASE 3, MULTICENTER, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) PLUS BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE ALONE AS A MAINTENANCE TREATMENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER WHOSE DISEASE DID NOT PROGRESS AFTER COMPLETION OF FIRST-LINE PLATINUM-CONTAINING CHEMOTHERAPY

Phase

Phase 3

Status

Completed

Conditions

Urothelial Cancer

Interventions

Avelumab; Best Supportive Care; Following the planned interim analysis for this study: Avelumab

Arms

• Arm A · Experimental
• Arm B · Other

Enrollment

700

Primary outcomes

• Overall Survival (OS)

Sponsor

Pfizer

Start

Apr 25, 2016

Primary completion

Oct 21, 2019

Results posted

Yes

Registry record

NCT02603432 · updated Mar 27, 2024

• Porte F, Granghaud A, Chang J, Kearney M, Morel A, Plessala I, Cawston H, Roiz J, Xiao Y, Solbes MN, Lambert P, Ravaud A, Loriot Y, Thiery-Vuillemin A, Levy P. Cost-effectiveness of avelumab first-line maintenance therapy for adult patients with locally advanced or metastatic urothelial carcinoma in France. PLoS One. 2024 May 10;19(5):e0302548. doi: 10.1371/journal.pone.0302548. eCollection 2024. PubMed 38728337
• Vashistha R, Noor Z, Dasgupta S, Pu J, Deng S. Application of statistical machine learning in biomarker selection. Sci Rep. 2023 Oct 26;13(1):18331. doi: 10.1038/s41598-023-45323-9. PubMed 37884606
• Bellmunt J, Chang J, Pavilack-Kirker M, Cappelleri JC, Costa N, Esterberg E, Kearney M, Hitchens A, Candrilli SD, Ajmera M. Evaluating Real-World Characteristics of Patients With Advanced Urothelial Carcinoma Eligible for Avelumab Maintenance Therapy: A Multicountry Retrospective Medical Chart Review. Clin Genitourin Cancer. 2023 Aug;21(4):459-466. doi: 10.1016/j.clgc.2023.03.011. Epub 2023 Mar 31. PubMed 37149458
• Grivas P, Park SH, Voog E, Caserta C, Gurney H, Bellmunt J, Kalofonos H, Ullen A, Loriot Y, Sridhar SS, Yamamoto Y, Petrylak DP, Sternberg CN, Gupta S, Huang B, Costa N, Laliberte RJ, di Pietro A, Valderrama BP, Powles T. Avelumab First-line Maintenance Therapy for Advanced Urothelial Carcinoma: Comprehensive Clinical Subgroup Analyses from the JAVELIN Bladder 100 Phase 3 Trial. Eur Urol. 2023 Jul;84(1):95-108. doi: 10.1016/j.eururo.2023.03.030. Epub 2023 Apr 28. PubMed 37121850
• Powles T, Park SH, Caserta C, Valderrama BP, Gurney H, Ullen A, Loriot Y, Sridhar SS, Sternberg CN, Bellmunt J, Aragon-Ching JB, Wang J, Huang B, Laliberte RJ, di Pietro A, Grivas P. Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma: Results From the JAVELIN Bladder 100 Trial After >/=2 Years of Follow-Up. J Clin Oncol. 2023 Jul 1;41(19):3486-3492. doi: 10.1200/JCO.22.01792. Epub 2023 Apr 18. PubMed 37071838
• Lee JL, Desai C, Park SH, Tsuchiya N, Su PJ, Chan TTW, Gurney H, Gao S, Wang J, Sandner R, di Pietro A, Eto M. Avelumab first-line maintenance plus best supportive care (BSC) vs. BSC alone for advanced urothelial carcinoma: JAVELIN Bladder 100 Asian subgroup analysis. Urol Oncol. 2023 May;41(5):256.e17-256.e25. doi: 10.1016/j.urolonc.2023.02.002. Epub 2023 Apr 3. PubMed 37019764
• Grivas P, Kopyltsov E, Su PJ, Parnis FX, Park SH, Yamamoto Y, Fong PC, Tournigand C, Climent Duran MA, Bamias A, Caserta C, Chang J, Cislo P, di Pietro A, Wang J, Powles T. Patient-reported Outcomes from JAVELIN Bladder 100: Avelumab First-line Maintenance Plus Best Supportive Care Versus Best Supportive Care Alone for Advanced Urothelial Carcinoma. Eur Urol. 2023 Apr;83(4):320-328. doi: 10.1016/j.eururo.2022.04.016. Epub 2022 May 30. PubMed 35654659
• Powles T, Park SH, Voog E, Caserta C, Valderrama BP, Gurney H, Kalofonos H, Radulovic S, Demey W, Ullen A, Loriot Y, Sridhar SS, Tsuchiya N, Kopyltsov E, Sternberg CN, Bellmunt J, Aragon-Ching JB, Petrylak DP, Laliberte RJ, Huang B, Costa N, Blake-Haskins JA, Grivas P. Plain language summary of results from the JAVELIN Bladder 100 study: avelumab maintenance treatment for advanced urothelial cancer. Future Oncol. 2022 Jun;18(19):2361-2371. doi: 10.2217/fon-2021-1631. Epub 2022 Apr 13. PubMed 35416053
• Tomita Y, Yamamoto Y, Tsuchiya N, Kanayama H, Eto M, Miyake H, Powles T, Yoshida M, Koide Y, Umeyama Y, di Pietro A, Uemura H. Avelumab first-line maintenance plus best supportive care (BSC) vs BSC alone for advanced urothelial carcinoma: JAVELIN Bladder 100 Japanese subgroup analysis. Int J Clin Oncol. 2022 Feb;27(2):383-395. doi: 10.1007/s10147-021-02067-8. Epub 2022 Jan 1. PubMed 34973108
• Powles T, Sridhar SS, Loriot Y, Bellmunt J, Mu XJ, Ching KA, Pu J, Sternberg CN, Petrylak DP, Tambaro R, Dourthe LM, Alvarez-Fernandez C, Aarts M, di Pietro A, Grivas P, Davis CB. Avelumab maintenance in advanced urothelial carcinoma: biomarker analysis of the phase 3 JAVELIN Bladder 100 trial. Nat Med. 2021 Dec;27(12):2200-2211. doi: 10.1038/s41591-021-01579-0. Epub 2021 Dec 10. PubMed 34893775
• Powles T, Park SH, Voog E, Caserta C, Valderrama BP, Gurney H, Kalofonos H, Radulovic S, Demey W, Ullen A, Loriot Y, Sridhar SS, Tsuchiya N, Kopyltsov E, Sternberg CN, Bellmunt J, Aragon-Ching JB, Petrylak DP, Laliberte R, Wang J, Huang B, Davis C, Fowst C, Costa N, Blake-Haskins JA, di Pietro A, Grivas P. Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2020 Sep 24;383(13):1218-1230. doi: 10.1056/NEJMoa2002788. Epub 2020 Sep 18. PubMed 32945632