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Clinical trial · no report yet · Phase 2
TROPHY-U-01 trial: what clinicians have said so far
Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread
- NCT03547973 ↗
- Active, not recruiting
- Gilead Sciences
- Deep size, estimated: 301+ verified statements once built
Discussed at: ESMO Congress 2026
We haven't built an HCP commentary report on TROPHY-U-01 (sacituzumab govitecan; sacituzumab govitecan plus pembrolizumab; sacituzumab govitecan plus cisplatin plus avelumab in unresectable locally advanced or metastatic urothelial cancer) 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.
Some of the questions raised in the 40 most recent indexed sources
Automated from the 40 newest of 158 indexed sources (Feb 2021 – Oct 2026). Each question is raised in at least two. Not an Erudio report: no source links. Not medical advice.
- Whether the sacituzumab govitecan, enfortumab vedotin and zimberelimab triplet improves on enfortumab vedotin plus pembrolizumab
- How tolerable the triplet is, and how often enfortumab vedotin has to be stopped
- Whether the triplet's early findings hold with longer follow-up and in larger randomized testing
Indexed commentary on TROPHY-U-01 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.
| Indexed so far | |
|---|---|
| 108 posts on X, typically up to 475 once built | |
| 25 podcast episodes, typically up to 110 once built | |
| 24 YouTube videos, typically up to 106 once built | |
| 1 video on X, typically up to 4 once built |
The trial
ClinicalTrials.gov- Official title
- A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer
- Phase
- Phase 2
- Status
- Active, not recruiting
- Conditions
- Metastatic Urothelial Cancer
- Interventions
- Sacituzumab Govitecan-hziy; Pembrolizumab; Cisplatin; Avelumab; Zimberelimab; Carboplatin; Gemcitabine; Domvanalimab; Enfortumab Vedotin
- Arms
- Cohort 1: Sacituzumab Govitecan-hziy (SG) · Experimental
- Cohort 2: SG · Experimental
- Cohort 3: SG + Pembrolizumab · Experimental
- Cohort 4: SG + Cisplatin + Avelumab (Dose Escalation Phase) · Experimental
- Cohort 4: SG + Cisplatin + Zimberelimab (ZIM) (Dose Expansion Phase) · Experimental
- Cohort 5 (Arm 1): SG + ZIM · Experimental
- Cohort 5 (Arm 2): Avelumab · Experimental
- Cohort 5 (Arm 3): ZIM · Experimental
- Cohort 6 (Arm 1): SG · Experimental
- Cohort 6 (Arm 2): SG + ZIM · Experimental
- Cohort 6 (Arm 3): SG + ZIM + Domvanalimab (DOM) · Experimental
- Cohort 6 (Arm 4): Carboplatin (CARBO) + Gemcitabine (GEM) · Experimental
- Cohort 7 (Phase 1: Safety Lad-in and Dose Expansion): SG + Enfortumab Vedotin (EV) + ZIM · Experimental
- Cohort 7 (Phase 2: Arm 1): SG + EV + ZIM · Experimental
- Cohort 7 (Phase 2: Arm 2): EV + ZIM · Experimental
- Cohort 7 (Phase 2: Arm 3): Optional Dose Optimization SG + EV + ZIM · Experimental
- Enrollment
- 502
- Primary outcomes
- Overall Response Rate (ORR) Based on Central Review by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Criteria (Cohorts 1 to 4 and 6)
- Progression free survival (PFS) Based on Central Review by RECIST 1.1 criteria (Cohort 5)
- ORR Based on Investigator Review by RECIST 1.1 Criteria (Cohort 7)
- Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) (Cohort 7)
- Percentage of Participants Experiencing any Clinically Significant Laboratory Abnormalities (Cohort 7)
- Sponsor
- Gilead Sciences with Merck KGaA, Darmstadt, Germany
- Start
- Aug 13, 2018
- Primary completion
- Apr 2030 (estimated)
- Results posted
- No
- Registry record
- NCT03547973 · updated Sep 1, 2026
Publications
linked from the registry- 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. PubMed 39186707
- 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. PubMed 38682560
- 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. PubMed 38261969
- 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. PubMed 33929895