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

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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)

INTRODUCTION

  • Org Study ID: SMT112-3008
  • Secondary ID: N/A
  • NCT ID: NCT07815665
  • Sponsor: Summit Therapeutics

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)

DETAILED DESCRIPTION

This Phase 2/3 study will be conducted in 2 parts. The first part is a Phase 2 randomized, open-label, 2 dose levels, parallel-arm study with the primary objective to evaluate safety and identify the recommended Phase 3 dose (RP3D) of ivonescimab in combination with EV. The second part is a randomized, open-label Phase 3 study with the primary objective to evaluate the efficacy and safety of ivonescimab (RP3D) plus EV versus pembrolizumab plus EV in patients with previously untreated LA/mUC.

For Phase 2 portion, patients will be randomized 1:1 to two arms consisting of 2 different dosages of ivonescimab.

* Arm A: Ivonescimab Dose 1 + EV
* Arm B: Ivonescimab Dose 2 + EV For Phase 3 portion, patients will be randomized 1:1 to the experimental arm (ivonescimab + EV) and the control arm (pembrolizumab + EV).
* Arm 1 (experimental): Ivonescimab RP3D + EV
* Arm 2 (SoC): Pembrolizumab 200 mg + EV

  • Overall Status
    Recruiting
  • Start Date
    September 10, 2026
  • Phase
    PHASE2, PHASE3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Phase 2 Primary Outcome Measure

Primary Outcome 1 - Timeframe: Through 90 days after the last study treatment

Primary Outcome 2 - Measure: Phase 2 Primary Outcome Measure

Primary Outcome 2 - Timeframe: From first dose until approximately 30 days after the last study treatment

Primary Outcome 3 - Measure: Phase 2 Primary Outcome measure

Primary Outcome 3 - Timeframe: assessed up to 3 years

Primary Outcome 4 - Measure: Phase 2 Primary Outcome Measure

Primary Outcome 4 - Timeframe: From date of randomization until the date of first documented progression or date of death from any cause

Primary Outcome 5 - Measure: Phase 3 Primary Outcome Measure

Primary Outcome 5 - Timeframe: whichever came first

Primary Outcome 6 - Measure: Phase 3 Primary Outcome Measure

Primary Outcome 6 - Timeframe: assessed up to 3 years

CONDITION

  • Metastatic Urothelial Carcinoma
  • Metastatic Urothelial Carcinoma (UC)

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: Summit Clinical Trial Information

Phone: 1-833-256-0522

Email: [email protected]

LOCATION

Facility Status Contact
Facility: Research Site
Los Angeles, California 90067
United States 		Status: Recruiting Contact: N/A
Facility: Research Site
Spokane, Washington 99208
United States 		Status: Recruiting Contact: N/A

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