Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2

Conditions

• Urothelial Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• disitamab vedotin — DRUG
  Given into the vein (IV; intravenous) every 2 weeks
• pembrolizumab — DRUG
  400mg given by IV every 6 weeks
• gemcitabine — DRUG
  1000 mg/m\^2 given by IV on days 1 and 8 of every 3-week cycle
• cisplatin — DRUG
  70 mg\^2 given by IV on day 1 of every 3-week cycle
• carboplatin — DRUG
  Area under the plasma concentration-time curve (AUC) 4.5 or 5 given by IV on day 1 of every 3-week cycle

Study Details

This study will enroll participants with urothelial cancer (UC). UC can include cancer of the bladder, kidney, or the tubes that carry pee through the body (ureter, urethra). This study will try to find out if the drugs disitamab vedotin with pembrolizumab works better than platinum-containing chemotherapy to treat patients with UC. This study will also test what side effects happen when participants take these drugs together. A side effect is anything a drug does to the body besides treating the disease. Participants in this study will have cancer that has spread through the body (metastatic) or spread near where it started (locally advanced). In this study, there are 2 different groups. Participants will be assigned to a group randomly. Participants in the disitamab vedotin arm will get the study drug disitamab vedotin once every two weeks and pembrolizumab once every 6 weeks. Participants in the standard of care arm will get gemcitabine once a week for 2 weeks with either cisplatin or carboplatin once every 3 weeks.

Key Dates

Start date

Sep 22, 2023

Status verified

Jun 2026

Primary completion

Jan 29, 2027

Completion

Apr 30, 2029

Study Design

Enrollment

412 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Disitamab vedotin arm
  disitamab vedotin + pembrolizumab
• Active Comparator: Standard of care arm
  gemcitabine + cisplatin OR carboplatin

Primary Outcome Measure

Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR) [ Time Frame: Approximately 3 years ]

Locations (89)

Find similar trials in Gilbert, AZ

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