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

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)

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.

Conditions3

Interventions5

Locations7 sites

Find trials near these locations

Related trials

• A Dose Escalation and Dose Expansion Clinical Study of STI-7349 in Subjects With Advanced Solid Tumors — The Fourth Affiliated Hospital of Zhejiang University School of Medicine
• A FIH, Phase I/IIa, Trial Assessing Feasibility of Administrations of TIL-based Immunotherapy in Patients With Metastatic CRC and PC — CuraCell TX AB
• A Phase 1 Study of APX-343A as Monotherapy or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors — Aptabio Therapeutics, Inc.
• A Phase I/II Trial of HCB101 in Combination With Pembrolizumab for Patients With Platinum-Refractory, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (SirH&N Trial) — Taipei Veterans General Hospital, Taiwan
• A Phase II Clinical Trial on Neo-adjuvant Pembrolizumab in Patients With pT3b-T4a/b cN0M0 Melanoma. — Universitair Ziekenhuis Brussel
• A Phase II Study to Evaluate the Efficacy and Safety of SKB571 in Recurrent or Metastatic HNSCC Participants — Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
• A Safety, Pharmacokinetic and Clinical Activity Study of NUC-7738 in Patients With Advanced Solid Tumours and Lymphoma — NuCana plc
• A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cancer) — Latin American Cooperative Oncology Group

Browse More Trials