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Clinical Trial Protocol

The JAVELIN Bladder Medley Trial: Avelumab-Based Combinations as First-Line Maintenance in Advanced Urothelial Carcinoma

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Pages 179-190 | Received 01 Jun 2023, Accepted 02 Aug 2023, Published online: 06 Sep 2023

References

  • Sung H , FerlayJ, SiegelRLet al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J. Clin.71(3), 209–249 (2021).
  • National Comprehensive Cancer Network . NCCN Clinical Practice Guidelines in Oncology: Bladder Cancer. v3.2023.
  • National Cancer Institute, SEER Cancer Stat Facts: Bladder Cancer. Bethesda, MD, USA. https://seer.cancer.gov/statfacts/html/urinb.html (Accessed 5July2023).
  • Swami U , GrivasP, PalSK, AgarwalN. Utilization of systemic therapy for treatment of advanced urothelial carcinoma: lessons from real world experience. Cancer Treat. Res. Commun.27, 100325 (2021).
  • Jensen JB , HaubergDS, DuusHjortsoe M, MadsenME, OlsenJ, AgerbækM. Treatment pattern and overall survival among patients with locally advanced or metastatic urothelial carcinoma: results from a complete nationwide unselected real-world registry study in Denmark from 2010 to 2017. Ann. Oncol.32(Suppl. 5), Abstract 707P (2021).
  • Niegisch G , GerullisH, LinSWet al. A real-world data study to evaluate treatment patterns, clinical characteristics and survival outcomes for first- and second-line treatment in locally advanced and metastatic urothelial cancer patients in Germany. J. Cancer9(8), 1337–1348 (2018).
  • Powles T , BellmuntJ, ComperatEet al. Bladder cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. Ann. Oncol.33(3), 244–258 (2022).
  • Cathomas R , LorchA, BruinsHMet al. The 2021 updated European Association of Urology guidelines on metastatic urothelial carcinoma. Eur. Urol.81(1), 95–103 (2021).
  • Powles T , ParkSH, VoogEet al. Avelumab maintenance therapy for advanced or metastatic urothelial carcinoma. N. Engl. J. Med.383(13), 1218–1230 (2020).
  • Heery CR , O’Sullivan-CoyneG, MadanRAet al. Avelumab for metastatic or locally advanced previously treated solid tumours (JAVELIN Solid Tumor): a Phase Ia, multicohort, dose-escalation trial. Lancet Oncol.18(5), 587–598 (2017).
  • Boyerinas B , JochemsC, FantiniMet al. Antibody-dependent cellular cytotoxicity activity of a novel anti-PD-L1 antibody avelumab (MSB0010718C) on human tumor cells. Cancer Immunol. Res.3(10), 1148–1157 (2015).
  • Bavencio (avelumab) . Prescribing information. EMD Serono, Inc., Rockland, MA, USA, an affiliate of Merck KGaA (2022).
  • Bavencio (avelumab). Summary of product characteristics. Merck Europe B.V., Amsterdam, The Netherlands, an affiliate of Merck KGaA (2023).
  • Powles T , ParkSH, VoogEet al. Plain language summary of results from the JAVELIN Bladder 100 study: avelumab maintenance treatment for advanced urothelial cancer. Future Oncol.18(19), 2361–2371 (2022).
  • Powles T , ParkSH, CasertaCet al. Avelumab first-line maintenance for advanced urothelial carcinoma: results from the JAVELIN Bladder 100 trial after ≥2 years of follow-up. J. Clin. Oncol.41(19), 3486–3492 (2023).
  • Powles T , SridharSS, LoriotYet al. Avelumab maintenance in advanced urothelial carcinoma: biomarker analysis of the phase 3 JAVELIN Bladder 100 trial. Nat. Med.27(12), 2200–2211 (2021).
  • Bardia A , HurvitzSA, TolaneySMet al. Sacituzumab govitecan in metastatic triple-negative breast cancer. N. Engl. J. Med.384(16), 1529–1541 (2021).
  • Goldenberg DM , CardilloTM, GovindanSV, RossiEA, SharkeyRM. Trop-2 is a novel target for solid cancer therapy with sacituzumab govitecan (IMMU-132), an antibody-drug conjugate (ADC). Oncotarget.6(26), 22496–22512 (2015).
  • Goldenberg DM , SharkeyRM. Antibody-drug conjugates targeting TROP-2 and incorporating SN-38: a case study of anti-TROP-2 sacituzumab govitecan. MAbs11(6), 987–995 (2019).
  • Xu C , JiangF, HuangHet al. The anti-TIGIT antibody M6223 induces significant anti-tumor efficacy and immune response via multiple mechanisms of action. J. Immunother. Cancer9(Suppl. 2), Abstract 326 (2021).
  • Miyazaki T , MaitiM, HennessyMet al. NKTR-255, a novel polymer-conjugated rhIL-15 with potent antitumor efficacy. J. Immunother. Cancer9(5), e002024 (2021).
  • Zaman S , JadidH, DensonAC, GrayJE. Targeting Trop-2 in solid tumors: future prospects. Onco. Targets Ther.12, 1781–1790 (2019).
  • Trodelvy (sacituzumab govitecan-hziy). Prescribing information. Gilead Sciences, Inc., Foster City, CA, USA (2023).
  • Trodelvy (sacituzumab govitecan-hziy). Summary of product characteristics. Gilead Sciences Ireland UC, Carrigtwohill, Co., Cork, Ireland (2023).
  • Tagawa ST , BalarAV, PetrylakDPet al. TROPHY-U-01: a Phase II open-label study of sacituzumab govitecan in patients with metastatic urothelial carcinoma progressing after platinum-based chemotherapy and checkpoint inhibitors. J. Clin. Oncol.39(22), 2474–2485 (2021).
  • Grivas P , TagawaST, BellmuntJet al. TROPiCS-04: study of sacituzumab govitecan in metastatic or locally advanced unresectable urothelial cancer that has progressed after platinum and checkpoint inhibitor therapy. J. Clin. Oncol.39(Suppl. 6), Abstract TPS498 (2021).
  • Grivas P , PouesselD, ParkCHet al. Primary analysis of TROPHY-U-01 cohort 3, a phase 2 study of sacituzumab govitecan (SG) in combination with pembrolizumab (Pembro) in patients (pts) with metastatic urothelial cancer (mUC) that progressed after platinum (PT)-based therapy. J. Clin. Oncol.41(Suppl. 6), Abstract 518 (2023).
  • Huang Z , QiG, MillerJS, ZhengSG. CD226: an emerging role in immunologic diseases. Front. Cell Dev. Biol.8, 564 (2020).
  • Johnston RJ , Comps-AgrarL, HackneyJet al. The immunoreceptor TIGIT regulates antitumor and antiviral CD8(+) T cell effector function. Cancer Cell26(6), 923–937 (2014).
  • He W , ZhangH, HanFet al. CD155T/TIGIT signaling regulates CD8(+) T-cell metabolism and promotes tumor progression in human gastric cancer. Cancer Res.77(22), 6375–6388 (2017).
  • Hung AL , MaxwellR, TheodrosDet al. TIGIT and PD-1 dual checkpoint blockade enhances antitumor immunity and survival in GBM. Oncoimmunology7(8), e1466769 (2018).
  • Titov A , SunN, KeltonC, JurzakM, MaH, XuC. Evaluation of novel anti-TIGIT antibody M6223 as a single agent and in combination with avelumab on human natural killer (NK) cell cytotoxicity. J. Immunother. Cancer10(Suppl. 2), Abstract 432 (2022).
  • Genentech press release . Genentech Reports Interim Results for Phase III SKYSCRAPER-01 Study in PD-L1-High Metastatic Non-Small Cell Lung Cancer (2022). https://www.gene.com/media/press-releases/14951/2022-05-10/genentech-reports-interim-results-for-ph (Accessed 5July2023).
  • Genentech press release . Genentech Provides Update on Phase III SKYSCRAPER-02 Study in Extensive-Stage Small Cell Lung Cancer (2022). https://www.gene.com/media/press-releases/14947/2022-03-29/genentech-provides-update-on-phase-iii-s (Accessed 5July2023).
  • Rudin CM , LiuSV, LuSet al. SKYSCRAPER-02: primary results of a Phase III, randomized, double-blind, placebo-controlled study of atezolizumab (atezo)+carboplatin+etoposide (CE) with or without tiragolumab (tira) in patients (pts) with untreated extensive-stage small cell lung cancer (ES-SCLC). J. Clin. Oncol.40(Suppl. 17), Abstract LBA8507 (2022).
  • Mettu NB , UlahannanSV, BendellJCet al. A Phase Ia/b open-label, dose-escalation study of etigilimab alone or in combination with nivolumab in patients with locally advanced or metastatic solid tumors. Clin. Cancer Res.28(5), 882–892 (2022).
  • Niu J , Maurice-DrorC, LeeDHet al. First-in-human Phase I study of the anti-TIGIT antibody vibostolimab as monotherapy or with pembrolizumab for advanced solid tumors, including non-small-cell lung cancer. Ann. Oncol.33(2), 169–180 (2022).
  • Cho BC , AbreuDR, HusseinMet al. Tiragolumab plus atezolizumab versus placebo plus atezolizumab as a first-line treatment for PD-L1-selected non-small-cell lung cancer (CITYSCAPE): primary and follow-up analyses of a randomised, double-blind, phase 2 study. Lancet Oncol.23(6), 781–792 (2022).
  • Kirk P , KuoP, AddepalliMet al. Pre-clinical efficacy and tolerability of NKTR-255, a polymer-conjugated IL-15 for immuno-oncology. J. Immunother. Cancer5(Suppl. 2), Abstract P332 (2017).
  • Julia EP , AmanteA, PampenaMB, MordohJ, LevyEM. Avelumab, an IgG1 anti-PD-L1 immune checkpoint inhibitor, triggers NK cell-mediated cytotoxicity and cytokine production against triple negative breast cancer cells. Front. Immunol.9, 2140 (2018).
  • Miyazaki T , KivimäeS, HennessyMet al. NKTR-255, a polymer-conjugated IL-15 enhances antibody-dependent cellular cytotoxicity mediated by NK cells in a B cell lymphoma model. Blood134(Suppl. 1), 5302 (2019).