Clinical trial · Interventional
A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma
A Randomized Phase 2/3 Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma (HARMONi-GU1)
NCT07815665CI-TRIAL-00126243HARMONi-GU1recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
A Randomized, Open-Label, Multicenter, Phase 2/3 Clinical Study of Ivonescimab in Combination with Enfortumab Vedotin vs Pembrolizumab in Combination with Enfortumab Vedotin in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma (HARMONi-GU1)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Urothelial Carcinoma | Urothelial Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Urothelial Carcinoma (UC) | Urothelial Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| enfortumab vedotin (EV) | Drug | Enfortumab Vedotin | ALIAS |
| Ivonescimab Dose 1 | Drug | — | UNRESOLVED |
| Ivonescimab Dose 2 | Drug | — | UNRESOLVED |
| Ivonescimab RP3D | Drug | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Phase 2: Arm A
- description
- Ivonescimab Dose 1 + EV
- interventionNames
- Drug: Ivonescimab Dose 1
- Drug: enfortumab vedotin (EV)
- type
- EXPERIMENTAL
- label
- Phase 2: Arm B
- description
- Ivonescimab Dose 2 + EV
- interventionNames
- Drug: enfortumab vedotin (EV)
- Drug: Ivonescimab Dose 2
- type
- EXPERIMENTAL
- label
- Phase 3: Arm 1
- description
- Ivonescimab RP3D (recommended Phase 3 dose) + EV
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years and older * ECOG 0-1 * Life expectancy ≥ 6 months * Histologically documented unresectable LA/mUC (transitional cell carcinoma) of the bladder, renal pelvis, ureter, or urethra with ≥50% urothelial carcinoma component * No prior systemic therapy for LA/mUC * At least one measurable non-cerebral lesion according to RECIST v1.1 * Adequate organ function Exclusion Criteria: * Locally advanced disease that is resectable or suitable for local therapy with curative intent. * Tumors containing any small cell or neuroendocrine differentiation * Ongoing sensory or motor neuropathy Grade 2 or higher. * Radiographic findings consistent with a high risk of bleeding * History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction, extensive bowel resection within 6 months prior to first dose.
References
Publications (0)
Data not yet available
No reference posted for this study.