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โ† Trials
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A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllSummit Therapeutics
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In plain words

What the trial is, and whether it could suit you

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)

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 18 years and older * ECOG 0-1 * Life expectancy โ‰ฅ 6 months * Histologically documented unresectable LA/mUC (transitional cell carcinoma) of the bladder, renal pelvis, ureter, or urethra with โ‰ฅ50% 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.
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What it tests

  • Ivonescimab Dose 1
  • enfortumab vedotin (EV)
  • Pembrolizumab
  • Ivonescimab Dose 2
  • Ivonescimab RP3D
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Where

7 sites
Research Site
Phoenix, United States
Research Site
Los Angeles, United States
Research Site
Washington D.C., United States
Research Site
Jacksonville, United States
Research Site
Rochester, United States
Research Site
Nashville, United States
Research Site
Spokane, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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