{"preliminary_commentary":{"by_channel":{"x_thread":108,"podcast":25,"youtube":24,"x_video":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03547973\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":{"generated_at":"2026-11-11T08:51:59.335Z","note":"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.","passages_read":40,"text":"- Whether the sacituzumab govitecan, enfortumab vedotin and zimberelimab triplet improves on enfortumab vedotin plus pembrolizumab\n- How tolerable the triplet is, and how often enfortumab vedotin has to be stopped\n- Whether the triplet's early findings hold with longer follow-up and in larger randomized testing","kind":"questions"},"drugs_tested":[["sacituzumab govitecan"],["sacituzumab govitecan","pembrolizumab"],["sacituzumab govitecan","cisplatin","avelumab"]],"indication":"unresectable locally advanced or metastatic urothelial cancer","name":"TROPHY-U-01","nct_id":"NCT03547973","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=trophy-u-01-nct03547973. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"TROPHY U-01","arms":[{"description":"Participants with urothelial cancer (UC) previously treated with platinum-based and/or checkpoint inhibitors (CPIs) will receive SG 10 mg/kg intravenously (IV) on Days 1 and 8 of a 21-day cycle.","label":"Cohort 1: Sacituzumab Govitecan-hziy (SG)","type":"EXPERIMENTAL"},{"description":"Participants with UC who are ineligible for platinum-based therapy and failed therapy with previous immune CPI therapy will receive SG 10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle.","label":"Cohort 2: SG","type":"EXPERIMENTAL"},{"description":"Participants who have had progression or recurrence of UC following a platinum-containing regimen in the metastatic setting, or progression or recurrence of UC within 12 months of completion of platinum-based therapy as neoadjuvant or adjuvant therapy will receive SG 10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle and pembrolizumab at the standard approved dose (200 mg) only on Day 1 of a 21-day cycle. Lower doses of SG may be tested based on dose-limiting toxicities (DLTs) observed to determine the Recommended Phase 2 Dose (RP2D) of SG in combination with pembrolizumab.","label":"Cohort 3: SG + Pembrolizumab","type":"EXPERIMENTAL"},{"description":"Participants with UC who have never received therapy with platinum in the metastatic setting or for unresectable locally advanced disease will first receive cisplatin (either at 70 mg/m\\^2 on Day 1 of a 21-day cycle or at a split dose of 35 mg/m\\^2 on Days 1 and 8 of a 21-day cycle with a maximum body surface area of 2) and sacituzumab govitecan-hziy with maximum dose of 10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle for up to 6 cycles. Based on DLTs observed, two additional lower doses may be tested to determine RP2D of sacituzumab govitecan-hziy in combination with cisplatin. If premature termination of 1 agent occurs due to toxicity, the other agent may be continued to complete up to 6 cycles of therapy. For participants who have not progressed, maintenance therapy will begin with infusions of avelumab 800 mg every 2 weeks beginning on Cycle 1, Day 1 and every 2 weeks thereafter and sacituzumab govitecan-hziy 10 mg/kg on Days 1 and 8 every 21 days.","label":"Cohort 4: SG + Cisplatin + Avelumab (Dose Escalation Phase)","type":"EXPERIMENTAL"},{"description":"Participants with UC who have never received therapy with platinum in the metastatic setting or for unresectable locally advanced disease will first receive cisplatin (either at 70 mg/m\\^2 on Day 1 of a 21-day cycle or at a split dose of 35 mg/m\\^2 on Days 1 and 8 of a 21-day cycle with a maximum body surface area of 2) and sacituzumab govitecan-hziy with maximum dose of 10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle for up to 6 cycles. If premature termination of 1 agent occurs due to toxicity, the other agent may be continued to complete up to 6 cycles of therapy. For participants who have not progressed, maintenance therapy will begin with infusions of sacituzumab govitecan-hziy 10 mg/kg on Days 1 and 8 every 21 days and zimberelimab 360 mg every 3 weeks (Day 1 of a 21-day cycle).","label":"Cohort 4: SG + Cisplatin + Zimberelimab (ZIM) (Dose Expansion Phase)","type":"EXPERIMENTAL"},{"description":"Participants in Cohort 5 will have completed 4 to 6 cycles of gemcitabine (GEM) + cisplatin therapy without PD prior to study entry. The safety lead-in will be conducted, in 6 to 8 participants (treated with SG 10 mg/kg IV on Day 1 and Day 8 of a 21-day cycle + ZIM 360 mg IV every 3 weeks on a 21-day cycle). Upon completion of the safety lead-in, participants will receive SG 10 mg/kg IV on Days 1 and 8 of a 21-day cycle followed by ZIM 360 mg IV, every 3 weeks (Q3W) (Day 1 of a 21-day cycle) until PD, unacceptable toxicity, or loss of clinical benefit. participants who must discontinue 1 agent may continue the other until PD, unacceptable toxicity, or loss of clinical benefit.","label":"Cohort 5 (Arm 1): SG + ZIM","type":"EXPERIMENTAL"},{"description":"Participants in Cohort 5 will have completed 4 to 6 cycles of gemcitabine (GEM) + cisplatin therapy without PD prior to study entry. The safety lead-in will be conducted, in 6 to 8 participants (treated with SG 10 mg/kg IV on Day 1 and Day 8 of a 21-day cycle + ZIM 360 mg IV every 3 weeks on a 21-day cycle). Upon completion of the safety lead-in, participants will be randomized to receive avelumab 800 mg IV every 2 weeks (Q2W) until PD, unacceptable toxicity, or loss of clinical benefit.","label":"Cohort 5 (Arm 2): Avelumab","type":"EXPERIMENTAL"},{"description":"Participants in Cohort 5 will have completed 4 to 6 cycles of gemcitabine (GEM) + cisplatin therapy without PD prior to study entry. The safety lead-in will be conducted, in 6 to 8 participants (treated with SG 10 mg/kg IV on Day 1 and Day 8 of a 21-day cycle + ZIM 360 mg IV every 3 weeks on a 21-day cycle).\n\nUpon completion of the safety lead-in, participants will be randomized to receive ZIM 360 mg IV Q3W (Day\n\n1 of a 21-day cycle) until PD, unacceptable toxicity, or loss of clinical benefit.","label":"Cohort 5 (Arm 3): ZIM","type":"EXPERIMENTAL"},{"description":"Upon completion of the safety lead-in, participants in Cohort 6 will be randomized and SG will be administered in cisplatin-ineligible participants who have never received therapy in the metastatic setting or for unresectable locally advanced disease. Treatment may be discontinued at any time, but participants will continue to be followed for tumor response until progression is documented, and alternate therapy is initiated. If participants discontinue therapy before evidence of radiologic progression, imaging should continue until radiologic progression is documented, if feasible.","label":"Cohort 6 (Arm 1): SG","type":"EXPERIMENTAL"},{"description":"Upon completion of the safety lead-in, participants in Cohort 6 will be randomized and SG in combination with ZIM will be administered in cisplatin-ineligible participants who have never received therapy in the metastatic setting or for unresectable locally advanced disease. The standard approved dose of SG will be used in combination with ZIM. Treatment may be discontinued at any time, but participants will continue to be followed for tumor response until progression is documented or alternate therapy is initiated. If participants discontinue therapy before evidence of radiologic progression, imaging should continue until radiologic progression is documented, if feasible.","label":"Cohort 6 (Arm 2): SG + ZIM","type":"EXPERIMENTAL"},{"description":"Upon completion of the safety lead-in, participants in Cohort 6 will be randomized and SG in combination with ZIM and DOM will be administered in cisplatin-ineligible participants who have never received therapy in the metastatic setting or for unresectable locally advanced disease.","label":"Cohort 6 (Arm 3): SG + ZIM + Domvanalimab (DOM)","type":"EXPERIMENTAL"},{"description":"Upon completion of the safety lead-in, participants in Cohort 6 will be randomized and CARBO in combination with GEM will be administered in cisplatin-ineligible participants who have never received therapy in the metastatic setting or for unresectable locally advanced disease. Participants without disease progression as assessed by the investigator after completion of 4 to 6 cycles of therapy may continue with maintenance therapy (avelumab 800 mg every 2 weeks) until loss of clinical benefit.","label":"Cohort 6 (Arm 4): Carboplatin (CARBO) + Gemcitabine (GEM)","type":"EXPERIMENTAL"},{"description":"In the safety lead-in phase, participants will receive a starting dose level of SG 7.5 mg/kg IV and starting dose level of EV 1.25 mg/kg IV will be administered on Days 1 and 8 of each 21-day cycle and ZIM 360 mg IV will be administered on Day 1 of each 21-day cycle.\n\nIn dose-expansion, participants will receive SG IV and EV IV at the RP2Ds on Days 1 and 8 of each 21-day cycle and ZIM 360 mg IV on Day 1 of each 21-day cycle.","label":"Cohort 7 (Phase 1: Safety Lad-in and Dose Expansion): SG + Enfortumab Vedotin (EV) + ZIM","type":"EXPERIMENTAL"},{"description":"Upon completion of the Cohort 7 dose-expansion phase, participants will receive SG IV at the RP2D in combination with EV IV at the RP2D, and ZIM 360 mg IV until PD, unacceptable toxicity, or loss of clinical benefit.","label":"Cohort 7 (Phase 2: Arm 1): SG + EV + ZIM","type":"EXPERIMENTAL"},{"description":"Upon completion of the Cohort 7 dose-expansion phase, participants will receive EV 1.25 mg/kg IV and ZIM 360 mg IV.","label":"Cohort 7 (Phase 2: Arm 2): EV + ZIM","type":"EXPERIMENTAL"},{"description":"Upon completion of the Cohort 7 dose-expansion phase, participants will receive SG IV at 1 dose level below the RP2D in combination with EV 1.25 mg/kg IV and ZIM 360 mg IV.","label":"Cohort 7 (Phase 2: Arm 3): Optional Dose Optimization SG + EV + ZIM","type":"EXPERIMENTAL"}],"collaborators":["Merck KGaA, Darmstadt, Germany"],"completion_date":{"date":"2030-04","type":"ESTIMATED"},"conditions":["Metastatic Urothelial Cancer"],"enrollment":{"count":502,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Sacituzumab Govitecan-hziy","otherNames":["IMMU-132","Trodelvy™"],"type":"DRUG"},{"name":"Pembrolizumab","otherNames":["KEYTRUDA®"],"type":"DRUG"},{"name":"Cisplatin","otherNames":[],"type":"DRUG"},{"name":"Avelumab","otherNames":["BAVENCIO®"],"type":"DRUG"},{"name":"Zimberelimab","otherNames":[],"type":"DRUG"},{"name":"Carboplatin","otherNames":[],"type":"DRUG"},{"name":"Gemcitabine","otherNames":[],"type":"DRUG"},{"name":"Domvanalimab","otherNames":[],"type":"DRUG"},{"name":"Enfortumab Vedotin","otherNames":[],"type":"DRUG"}],"last_update":"2026-09-01","lead_sponsor":"Gilead Sciences","official_title":"A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2030-04","type":"ESTIMATED"},"primary_outcomes":[{"measure":"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)","timeFrame":"Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))"},{"measure":"Progression free survival (PFS) Based on Central Review by RECIST 1.1 criteria (Cohort 5)","timeFrame":"Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))"},{"measure":"ORR Based on Investigator Review by RECIST 1.1 Criteria (Cohort 7)","timeFrame":"Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))"},{"measure":"Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) (Cohort 7)","timeFrame":"First dose date up to last dose date plus 30 days (approximately 3 years)"},{"measure":"Percentage of Participants Experiencing any Clinically Significant Laboratory Abnormalities (Cohort 7)","timeFrame":"First dose date up to last dose date plus 30 days (approximately 3 years)"}],"references":[{"citation":"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.","pmid":"39186707","type":"DERIVED"},{"citation":"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.","pmid":"38682560","type":"DERIVED"},{"citation":"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.","pmid":"38261969","type":"DERIVED"},{"citation":"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.","pmid":"33929895","type":"DERIVED"}],"start_date":{"date":"2018-08-13","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread","url":"https://clinicaltrials.gov/study/NCT03547973"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/trophy-u-01-nct03547973"}