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)

Status

Not yet recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2026-525831-17-00

Enrollment

Registered

2026-09-21

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced or Metastatic Urothelial Carcinoma

Brief summary

Phase II • Adverse events (AEs) as characterized by type, incidence, severity, seriousness, and relationship to study treatment, Phase II • Laboratory abnormalities as characterized by type, incidence, and severity, Phase II • Objective response rate (ORR)a, Phase II • PK characteristics: ivonescimab serum concentration profiles, Phase III • PFS per RECIST v1.1 by Independent Radiology Review Committee (IRRC), Phase III • OS

Detailed description

ORRa, DORa, AEs as characterized by type, incidence, severity, seriousness, and relationship to study treatment, Laboratory abnormalities as characterized by type, incidence, and severity, PK characteristics: ivonescimab serum concentration profiles, Incidence of ADA against ivonescimab

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion.

DRUGPadcev 20 mg powder for concentrate for solution for infusion

DRUGPadcev 30 mg powder for concentrate for solution for infusion

DRUGivonescimab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase II • Adverse events (AEs) as characterized by type, incidence, severity, seriousness, and relationship to study treatment, Phase II • Laboratory abnormalities as characterized by type, incidence, and severity, Phase II • Objective response rate (ORR)a, Phase II • PK characteristics: ivonescimab serum concentration profiles, Phase III • PFS per RECIST v1.1 by Independent Radiology Review Committee (IRRC), Phase III • OS	—

Measure

Time frame

—

Secondary

Measure	Time frame
ORRa, DORa, AEs as characterized by type, incidence, severity, seriousness, and relationship to study treatment, Laboratory abnormalities as characterized by type, incidence, and severity, PK characteristics: ivonescimab serum concentration profiles, Incidence of ADA against ivonescimab	—

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 22, 2026