Recruiting
Phase 2
Phase 3

Ivonescimab & Enfortumab Vedotin

Sponsor:

Summit Therapeutics

Code:

NCT07815665

Conditions

Metastatic Urothelial Carcinoma

Metastatic Urothelial Carcinoma (UC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ivonescimab Dose 1

enfortumab vedotin (EV)

Pembrolizumab

Ivonescimab Dose 2

Ivonescimab RP3D

Study Details

Brief summary:

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

Metastatic Urothelial Carcinoma

Metastatic Urothelial Carcinoma (UC)

Study ID

NCT07815665

Start date

Sep 10, 2026

Status verified date

Sep, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Oct 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Ivonescimab Dose 1

First ivonescimab dose to be tested in Phase 2

enfortumab vedotin (EV)

Standard of care therapy

Pembrolizumab

200 mg

Ivonescimab Dose 2

Second Ivonescimab dose to be tested in Phase 2 part of the study

Ivonescimab RP3D

Recommended Phase 3 dose of Ivonescimab after Phase 2 data analysis

Primary outcome measure

  • Phase 2 Primary Outcome Measure [ Time Frame: Through 90 days after the last study treatment ]
  • Phase 2 Primary Outcome Measure [ Time Frame: From first dose until approximately 30 days after the last study treatment, assessed up to 3 years ]
  • Phase 2 Primary Outcome measure [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years ]
  • Phase 2 Primary Outcome Measure [ Time Frame: From first dose until end of treatment, assessed up to 3 years ]
  • Phase 3 Primary Outcome Measure [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years. ]
  • Phase 3 Primary Outcome Measure [ Time Frame: From date of randomization until the end of study, assessed up to 4 years ]

Central Contacts and Locations

Central contacts

Summit Clinical Trial Information

1-833-256-0522medicalinformation@smmttx.com

Locations

Research Site

Recruiting

Los Angeles, California, United States, 90067

Research Site

Recruiting

Spokane, Washington, United States, 99208

More Information

Sponsor

Summit Therapeutics

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Keywords

  • LA/mUC
  • Ivonescimab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by Summit Therapeutics on 2026-09-11.