NCT05911295|Active Not RecruitingPhase 3DMCFDA Drug

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

An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination With Pembrolizumab Versus Chemotherapy in Subjects With Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma That Expresses HER2 (IHC 1+ and Greater)

Seagen, a wholly owned subsidiary of Pfizer ClinicalTrials.gov

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3 other identifiers

SGNDV-001C57310012022-501105-12-00

Study Type

interventional

Target

412

Locations

24 countries

Sites

279

Timeline

RegisteredJun 2023

StartedSep 2023

CompletionApr 2029

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

412

participants targeted

Target at P50-P75 for phase_3

Timeline

35mo left

Started Sep 2023

Longer than P75 for phase_3

Geographic Reach

24 countries

279 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.6 years study duration

Study Progress49%

Sep 2023Apr 2029

First Submitted

Initial submission to the registry

June 9, 2023

Completed

13 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed

3 months until next milestone

Study Start

First participant enrolled

September 22, 2023

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected

2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2029

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

June 9, 2023

Last Update Submit

April 17, 2026

Conditions

Urothelial Carcinoma

Keywords

Urothelial CancerLA/mUCBladder CancerHER2 OverexpressionHER2 AmplificationHER2Seattle Genetics

Outcome Measures

Primary Outcomes (2)

Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR)
The time from randomization to first documentation of disease progression per RECIST v1.1 by BICR, or to death due to any cause.
Approximately 3 years
Overall survival (OS)
The time from date of randomization to date of death due to any cause.
Approximately 5 years

Secondary Outcomes (15)

Objective response rate (ORR) per RECIST v1.1 by BICR
Approximately 3 years
ORR per RECIST v1.1 by investigator assessment
Approximately 3 years
Duration of Response (DOR) per RECIST v1.1 by BICR
Approximately 3 years
DOR per RECIST v1.1 by investigator assessment
Approximately 3 years
Control Rate (DCR) per RECIST v1.1 by BICR
Approximately 3 years
+10 more secondary outcomes

Study Arms (2)

Disitamab vedotin arm

EXPERIMENTAL

disitamab vedotin + pembrolizumab

Drug: disitamab vedotinDrug: pembrolizumab

Standard of care arm

ACTIVE COMPARATOR

gemcitabine + cisplatin OR carboplatin

Drug: gemcitabineDrug: cisplatinDrug: carboplatin

Interventions

disitamab vedotinDRUG

Given into the vein (IV; intravenous) every 2 weeks

Also known as: RC48, RC48-ADC

Disitamab vedotin arm

pembrolizumabDRUG

400mg given by IV every 6 weeks

Also known as: KEYTRUDA®

Disitamab vedotin arm

gemcitabineDRUG

1000 mg/m\^2 given by IV on days 1 and 8 of every 3-week cycle

Also known as: Gemzar

Standard of care arm

cisplatinDRUG

70 mg\^2 given by IV on day 1 of every 3-week cycle

Standard of care arm

carboplatinDRUG

Area under the plasma concentration-time curve (AUC) 4.5 or 5 given by IV on day 1 of every 3-week cycle

Standard of care arm

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histopathological confirmation of locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra.
Measurable disease by investigator assessment per RECIST v1.1.
Participant must not have received prior systemic therapy for LA/mUC. Exception will be made for neoadjuvant or adjuvant therapy, if disease recurrence/progression occurred more than 12 months after the last dose of therapy.
Eligible to receive cisplatin- or carboplatin-containing chemotherapy.
Able to provide archived formalin-fixed paraffin-embedded tumor tissue blocks from a muscle-invasive or metastatic UC lesion or biopsy of metastatic UC prior to treatment initiation. If archival tissue is not available a newly obtained baseline biopsy of an accessible tumor lesion is required within 28 days of cycle 1 day 1.
HER2 expression of 1+ or greater on immunohistochemistry (IHC).
Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2 within 7 days prior to randomization.

You may not qualify if:

Known hypersensitivity to disitamab vedotin, cisplatin, carboplatin, gemcitabine, or pembrolizumab or any of their components.
History of severe/life threatening immune-related adverse event (irAE) with PD-(L)1 inhibitors are excluded.
Central nervous system (CNS) and/or leptomeningeal metastasis. Participants with treated CNS metastases are permitted if all of the following are met.
CNS metastases have been clinically stable for at least 4 weeks and baseline scans show no evidence of new or worsening CNS metastasis.
Participant is on a stable dose of ≤ 10 mg/day of prednisone or equivalent for at least 2 weeks.
History of or active autoimmune disease that has required systemic treatment in the past 2 years.
Prior treatment with an agent directed to another stimulatory or co-inhibitory T cell receptor (including but not limited to CD137 agonists, CAR-T cell therapy, CTLA-4 inhibitors, or OX-40 agonists).
Prior solid organ or bone marrow transplantation.
Pleural effusion or ascites with symptoms or requiring symptomatic treatment.
Estimated life expectancy \<12 week
Prior treatment with an MMAE agent or anti-HER2 therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

RemeGen Co., Ltd.collaborator
Merck Sharp & Dohme LLCcollaborator
Seagen, a wholly owned subsidiary of Pfizerlead

Study Sites (279)

Banner Gateway Medical Center

Gilbert, Arizona, 85234, United States

Location

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

UCLA Hematology/Oncology - Alhambra

Alhambra, California, 91801, United States

Location

Foothill Cardioology

Arcadia, California, 91007, United States

Location

Beverly Hills Multi-Specialties Practice

Beverly Hills, California, 90211, United States

Location

Providence Saint Joseph Medical Center

Burbank, California, 91505, United States

Location

UCLA Burbank Cardiology

Burbank, California, 91505, United States

Location

UCLA Hematology/Oncology - Burbank

Burbank, California, 91505, United States

Location

UCLA Calabasas Specialty Care

Calabasas, California, 91302, United States

Location

UCLA Encino Specialty Care (Radiology)

Encino, California, 91436, United States

Location

UCLA Hematology/Oncology - Encino

Encino, California, 91436, United States

Location

Helios Clinical Research

Fountain Valley, California, 92708, United States

Location

Helios Clinical Research

Glendale, California, 91204, United States

Location

Foothill Cardiology Glendora

Glendora, California, 91741, United States

Location

Helios Clinical Research

Long Beach, California, 90805, United States

Location

UCLA Downtown Los Angeles Primary & Specialty Care

Los Angeles, California, 90017, United States

Location

UCLA Cardiovascular Center

Los Angeles, California, 90095, United States

Location

UCLA Department of Medicine-Hematology/Oncology

Los Angeles, California, 90095, United States

Location

UCLA Hematology & Oncology Clinic

Los Angeles, California, 90095, United States

Location

UCLA Hematology / Oncology

Los Angeles, California, 90095, United States

Location

UCLA Westwood Specialty Care

Los Angeles, California, 90095, United States

Location

UCLA Montecito Primary & Specialty Care

Montecito, California, 93108, United States

Location

Pacific Cancer Care

Monterey, California, 93940, United States

Location

Newport Diagnostics

Newport Beach, California, 92660, United States

Location

Foothill Cardiology Pasadena

Pasadena, California, 91105, United States

Location

Southern California Heart Specialists

Pasadena, California, 91105, United States

Location

UCLA Porter Ranch Primary & Specialty Care

Porter Ranch, California, 91326, United States

Location

UCSF Center at China Basin Imaging

San Francisco, California, 94107, United States

Location

Helen Diller Family Comprehensive Cancer Center - Imaging Post

San Francisco, California, 94115, United States

Location

UCSF Cancer Center MZ Phlebotomy

San Francisco, California, 94115, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

UCSF Mount Zion Phlebotomy

San Francisco, California, 94115, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

UCSF Parnassus Phlebotomy

San Francisco, California, 94143, United States

Location

UCSF Parnassus-5 Lab

San Francisco, California, 94143, United States

Location

Cardiovascular Care and Prevention Center at Mission Bay