NCT04879329 · Seagen, a wholly owned subsidiary of Pfizer
A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2
What this study is about
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).
View original scientific description
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.
Interventions
DRUG
disitamab vedotin
Given into the vein (IV; intravenous) every 2 weeks.
DRUG
pembrolizumab
Given by IV on Day 1 of each 6-week cycle.
Primary outcome measures
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
The proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1
Incidence of adverse events (AEs) (Cohorts D and E)
Time frame: Approximately 2 years
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Incidence of dose alterations (Cohorts D and E)
Time frame: Approximately 2 years
Incidence of laboratory abnormalities (Cohorts D and E)
Time frame: Approximately 2 years
To be summarized using descriptive statistics.
Incidence of electrocardiogram (ECG) abnormalities (Cohorts D and E)
Time frame: Approximately 2 years
Change from baseline of left ventricular ejection fraction (LVEF) (Cohorts D and E)
Time frame: Approximately 2 years
Pharmacokinetic (PK) parameter - Area under the curve (AUC) (Cohorts D and E)
Time frame: Through 30-37 days following the last dose of DV; up to approximately 2 years
To be summarized using descriptive statistics.
PK parameter - Maximum concentration (Cmax) (Cohorts D and E)
Time frame: Through 30-37 days following the last dose of DV; up to approximately 2 years
To be summarized using descriptive statistics.
PK parameter - Time to maximum concentration (Tmax) (Cohorts D and E)
Time frame: Through 30-37 days following the last dose of DV; up to approximately 2 years
To be summarized using descriptive statistics.
PK parameter - Trough concentration (Ctrough) (Cohorts D and E)
Time frame: Through 30-37 days following the last dose of DV; up to approximately 2 years
To be summarized using descriptive statistics.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Cohorts A and B
- Histopathologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra
- Participants must have received only 1 or 2 lines of prior systemic treatment for LA/mUC, including 1 line of platinum-containing chemotherapy
- At least one measurable lesion by investigator assessment based on RECIST version 1.1.
- HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Cohort C
- Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra
- No prior systemic therapy for LA/mUC
- Neoadjuvant or adjuvant therapy, including PD-(L)1 inhibitors, is acceptable, if disease recurrence/progression occurred more than 12 months after the last dose of systemic therap
Where
- Gilbert, Arizona
- Anaheim, California
- Arcadia, California
- Baldwin Park, California
- Bellflower, California
- Beverly Hills, California
- Burbank, California
- Duarte, California
- Encino, California
- Fontana, California
- Glendora, California
- Harbor City, California
And 87 more locations — see the full list below.
Collaborators
Merck Sharp & Dohme LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 21, 2026 · Source of record for eligibility and locations