A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Summit Therapeutics
Study ID
NCT07815665
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Metastatic Urothelial Carcinoma
  • Metastatic Urothelial Carcinoma (UC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ivonescimab Dose 1 — DRUG
    First ivonescimab dose to be tested in Phase 2
  • enfortumab vedotin (EV) — DRUG
    Standard of care therapy
  • Pembrolizumab — DRUG
    200 mg
  • Ivonescimab Dose 2 — DRUG
    Second Ivonescimab dose to be tested in Phase 2 part of the study
  • Ivonescimab RP3D — DRUG
    Recommended Phase 3 dose of Ivonescimab after Phase 2 data analysis

Study Details

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)

Key Dates

First listed
Sep 11, 2026
Start date
Sep 10, 2026
Status verified
Sep 2026
Primary completion
Oct 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 2: Arm A
    Ivonescimab Dose 1 + EV
  • Experimental: Phase 2: Arm B
    Ivonescimab Dose 2 + EV
  • Experimental: Phase 3: Arm 1
    Ivonescimab RP3D (recommended Phase 3 dose) + EV
  • Active Comparator: Phase 3: Arm 2
    Pembrolizumab 200 mg + EV

Primary Outcome Measure

Phase 2 Primary Outcome Measure [ Time Frame: Through 90 days after the last study treatment ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Research SitePhoenixArizona85054-
Research SiteLos AngelesCalifornia90067-
Research SiteWashington D.C.District of Columbia20010-
Research SiteJacksonvilleFlorida32224-
Research SiteRochesterMinnesota55905-
Research SiteNashvilleTennessee37203-
Research SiteSpokaneWashington99208-

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