drugset / Trial / NCT03547973
Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC).
Timeline
- Start
- 2018-08-13
- Primary completion
- 2030-04
- Completion
- 2030-04
Publications
- Petrylak DP, Tagawa ST, Jain RK, Bupathi M, Balar A, Kalebasty AR, George S, Palmbos P, Nordquist L, Davis N, Ramamurthy C, Sternberg CN, Loriot Y, Agarwal N, Park C, Tonelli J, Vance M, Zhou H, Grivas P. TROPHY-U-01 Cohort 2: A Phase II Study of Sacituzumab Govitecan in Cisplatin-Ineligible Patients With Metastatic Urothelial Cancer Progressing After Previous Checkpoint Inhibitor Therapy. J Clin Oncol. 2024 Oct 10;42(29):3410-3420. doi: 10.1200/JCO.23.01720. Epub 2024 Aug 26.
- Loriot Y, Kalebasty AR, Flechon A, Jain RK, Gupta S, Bupathi M, Beuzeboc P, Palmbos P, Balar AV, Kyriakopoulos CE, Pouessel D, Sternberg CN, Tonelli J, Sierecki M, Zhou H, Grivas P, Barthelemy P, Bangs R, Tagawa ST. A plain language summary of the TROPHY-U-01 study: sacituzumab govitecan use in people with locally advanced or metastatic urothelial cancer. Future Oncol. 2024;20(23):1621-1631. doi: 10.2217/fon-2023-1030. Epub 2024 Jun 5.
- Grivas P, Pouessel D, Park CH, Barthelemy P, Bupathi M, Petrylak DP, Agarwal N, Gupta S, Flechon A, Ramamurthy C, Davis NB, Recio-Boiles A, Sternberg CN, Bhatia A, Pichardo C, Sierecki M, Tonelli J, Zhou H, Tagawa ST, Loriot Y. Sacituzumab Govitecan in Combination With Pembrolizumab for Patients With Metastatic Urothelial Cancer That Progressed After Platinum-Based Chemotherapy: TROPHY-U-01 Cohort 3. J Clin Oncol. 2024 Apr 20;42(12):1415-1425. doi: 10.1200/JCO.22.02835. Epub 2024 Jan 23.
- Tagawa ST, Balar AV, Petrylak DP, Kalebasty AR, Loriot Y, Flechon A, Jain RK, Agarwal N, Bupathi M, Barthelemy P, Beuzeboc P, Palmbos P, Kyriakopoulos CE, Pouessel D, Sternberg CN, Hong Q, Goswami T, Itri LM, Grivas P. 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. 2021 Aug 1;39(22):2474-2485. doi: 10.1200/JCO.20.03489. Epub 2021 Apr 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avelumab | Monoclonal antibody | 800 mg | — |
| Subject | Carboplatin | Small molecule | — | — |
| Subject | Cisplatin | Other / unclassified | 35 mg/m2 | — |
| Subject | Cisplatin | Other / unclassified | 70 mg/m2 | — |
| Subject | Domvanalimab | Monoclonal antibody | — | Intravenous |
| Subject | Enfortumab Vedotin | Other / unclassified | 1.25 mg/kg | Intravenous |
| Subject | Gemcitabine | Small molecule | — | — |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | — |
| Subject | Sacituzumab Govitecan | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Subject | Sacituzumab Govitecan | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Zimberelimab | Monoclonal antibody | 360 mg | Intravenous |