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OncoMatch/Clinical Trials/NCT04879329

A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2

Is NCT04879329 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including disitamab vedotin and pembrolizumab for urothelial carcinoma.

Phase 2RecruitingSeagen, a wholly owned subsidiary of PfizerNCT04879329Data as of May 2026

Treatment: disitamab vedotin · pembrolizumabThis study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). It will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.

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Extracted eligibility criteria

Cancer type

Urothelial Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) IHC 1+ (IHC 1+, 2+ or 3+)

HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample

Required: HER2 (ERBB2) IHC 2+ (IHC 1+, 2+ or 3+)

HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample

Required: HER2 (ERBB2) IHC 3+ (IHC 1+, 2+ or 3+)

HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Banner Gateway Medical Center · Gilbert, Arizona
  • Banner MD Anderson Cancer Center · Gilbert, Arizona
  • Kaiser Permanente Anaheim Kraemer Medical Offices · Anaheim, California
  • Foothill Cardioology · Arcadia, California
  • Kaiser Permanente Baldwin Park Medical Center · Baldwin Park, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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