A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses 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
  Given by IV on Day 1 of each 6-week cycle.

Study Details

This 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.

Key Dates

Start date

May 3, 2022

Status verified

Apr 2026

Primary completion

Dec 11, 2026

Completion

Apr 14, 2029

Study Design

Enrollment

372 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A - DV monotherapy for HER2-positive tumor types
  Disitamab vedotin monotherapy
• Experimental: Cohort B - DV monotherapy for HER2-low tumor types
  Disitamab vedotin monotherapy
• Experimental: Cohort C - Non-randomized combination therapy
  Disitamab vedotin + pembrolizumab
• Experimental: Cohort C - Randomized combination therapy
  Disitamab vedotin + pembrolizumab
• Experimental: Cohort C - Randomized monotherapy
  Disitamab vedotin monotherapy
• Experimental: Cohort D - DV monotherapy (Japan only)
  Disitamab vedotin monotherapy
• Experimental: Cohort E - DV combination therapy (Japan only)
  Disitamab vedotin + pembrolizumab
• Experimental: Cohort G - DV monotherapy
  Disitamab vedotin

Primary Outcome Measure

Confirmed Objective Response Rate (cORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) by blinded independent central review (BICR) (Cohorts A, B, C, and G) [ Time Frame: Duration of treatment; approximately 2 years ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (159)

Find similar trials in Gilbert, AZ

Related Studies

• Modern Immunotherapy in BCG-Unresponsive, BCG-Relapsing and High Risk BCG-Naive Non-Muscle Invasive Urothelial Carcinoma of the Bladder
  PHASE1/PHASE2 · Recruiting · Noah Hahn, M.D. · Phoenix, Arizona
• SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
  Recruiting · Massive Bio, Inc. · Birmingham, Alabama
• A Multicenter Cancer Biospecimen Collection Study
  Recruiting · Cofactor Genomics, Inc. · San Francisco, California
• An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy
  Recruiting · University of Texas Southwestern Medical Center · Dallas, Texas