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Antibody-Drug Conjugate
Disitamab Vedotin + Pembrolizumab for Bladder Cancer
Phase 2
Recruiting
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Cohort D: Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of study; approximately 3 years
Awards & highlights
Study Summary
This trial will test if disitamab vedotin, alone or with pembrolizumab, can effectively and safely treat HER2 expressing urothelial cancer.
Who is the study for?
This trial is for adults with advanced urothelial cancer that expresses HER2 and can't be removed by surgery or has spread. They should have had certain prior treatments, including platinum chemotherapy and PD-(L)1 inhibitors. Participants need to have at least one measurable tumor lesion, an ECOG performance status of 0-2, and no recent other cancer therapies.Check my eligibility
What is being tested?
The study tests disitamab vedotin alone or combined with pembrolizumab in treating HER2 expressing urothelial cancer. It aims to evaluate the effectiveness and safety of these drugs in patients whose cancer is locally advanced or metastatic.See study design
What are the potential side effects?
Possible side effects include reactions related to drug infusion, nerve damage (neuropathy), immune system complications affecting organs, fatigue, hair loss not beyond Grade 2 alopecia, and any previous treatment-related issues must be mild except for hair loss.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer originates from the urinary system and cannot be surgically removed.
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My cancer originates from the urinary system.
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My cancer's HER2 status is confirmed to be 1+, 2+, or 3+.
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I am fully active or can carry out light work.
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I am able to care for myself and perform daily activities.
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I have previously been treated with enfortumab vedotin.
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I've had 1 or 2 treatments for my bladder cancer, including a platinum-based chemotherapy.
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I have had one treatment with platinum-based chemotherapy.
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I have previously been treated with PD-(L)1 inhibitors.
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I am fully active or can carry out light work.
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I have completed all standard care treatments for my condition in Japan.
Select...
My cancer originates from the urinary system.
Select...
My cancer's HER2 status is 1+, 2+, or 3+ based on a lab test.
Select...
I have not had any drug treatments for my advanced bladder cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of study; approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of study; approximately 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline of left ventricular ejection fraction (LVEF) (Cohorts D and E)
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, and C)
Incidence of adverse events (AEs) (Cohorts D and E)
+7 moreSecondary outcome measures
Change from baseline of LVEF (Cohorts A, B, and C)
Confirmed DOR per RECIST v1.1 by investigator assessment (Cohorts A, B, and C)
Confirmed Duration of Response (DOR) per RECIST v1.1 by BICR (Cohorts A, B, and C)
+18 moreTrial Design
7Treatment groups
Experimental Treatment
Group I: Cohort E - DV combination therapy (Japan only)Experimental Treatment2 Interventions
Disitamab vedotin + pembrolizumab
Group II: Cohort D - DV monotherapy (Japan only)Experimental Treatment1 Intervention
Disitamab vedotin monotherapy
Group III: Cohort C - Randomized monotherapyExperimental Treatment1 Intervention
Disitamab vedotin monotherapy
Group IV: Cohort C - Randomized combination therapyExperimental Treatment2 Interventions
Disitamab vedotin + pembrolizumab
Group V: Cohort C - Non-randomized combination therapyExperimental Treatment2 Interventions
Disitamab vedotin + pembrolizumab
Group VI: Cohort B - DV monotherapy for HER2-low tumor typesExperimental Treatment1 Intervention
Disitamab vedotin monotherapy
Group VII: Cohort A - DV monotherapy for HER2-positive tumor typesExperimental Treatment1 Intervention
Disitamab vedotin monotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,339 Total Patients Enrolled
RemeGen Co., Ltd.Industry Sponsor
74 Previous Clinical Trials
9,728 Total Patients Enrolled
Seagen Inc.Lead Sponsor
208 Previous Clinical Trials
73,896 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer treatment in the last 2 weeks.You have advanced or metastatic urothelial cancer, which includes cancer in areas like the bladder, ureters, urethra or renal pelvis. You have received no more than two prior treatments including one treatment with platinum-containing chemotherapy. Your HER2-expression status has been found to be IHC 1+, 2+ or 3+ in the tumor sample provided. You have an ECOG performance status score of 0 or 1 and at least one measurable lesion according to RECIST version 1.1.My cancer originates from the urinary system and cannot be surgically removed.I am not allergic to disitamab vedotin, pembrolizumab, or their ingredients.My cancer originates from the urinary system.I have not had treatments targeting specific immune system receptors.My cancer's HER2 status is confirmed to be 1+, 2+, or 3+.I have mild or worse nerve damage in my hands or feet.I am fully active or can carry out light work.I have experienced severe side effects from previous treatments.I am able to care for myself and perform daily activities.I have previously received treatments targeting HER2 or using antibody-drug conjugates.My cancer originates from the urinary system and is confirmed by tissue analysis.I have previously been treated with enfortumab vedotin.My side effects from past treatments are still severe, except for hair loss.I've had 1 or 2 treatments for my bladder cancer, including a platinum-based chemotherapy.My cancer returned more than a year after my last treatment.I have had one treatment with platinum-based chemotherapy.I have previously been treated with PD-(L)1 inhibitors.I haven't had cancer treatment in the last 2 weeks.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I am fully active or can carry out light work.I have moderate to severe numbness, tingling, or muscle weakness.I have completed all standard care treatments for my condition in Japan.I am considered fit for chemotherapy that includes cisplatin or carboplatin.I am not allergic to disitamab vedotin, pembrolizumab, or their ingredients.My cancer originates from the urinary system.I have not fully recovered from major surgery within the last 4 weeks.My cancer's HER2 status is 1+, 2+, or 3+ based on a lab test.I have not had any drug treatments for my advanced bladder cancer.I have not had any cancer treatment in the last 2 weeks.I haven't had cancer treatment in the last 2 weeks.My cancer returned more than a year after my last treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A - DV monotherapy for HER2-positive tumor types
- Group 2: Cohort C - Randomized combination therapy
- Group 3: Cohort C - Randomized monotherapy
- Group 4: Cohort B - DV monotherapy for HER2-low tumor types
- Group 5: Cohort C - Non-randomized combination therapy
- Group 6: Cohort E - DV combination therapy (Japan only)
- Group 7: Cohort D - DV monotherapy (Japan only)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there different sites where I can participate in this trial?
"In total, there are 12 different hospitals conducting this trial. A few notable locations include the Levine Cancer Institute in Charlotte, Case Western Reserve University / University Hospitals Cleveland Medical Center in Cleveland, and UCLA Medical Center / David Geffen School of Medicine in Los Angeles."
Answered by AI
Do you need more volunteers for this research?
"Yes, this information can be found on the website clinicaltrials.gov. The trial was originally posted on May 3rd, 2022 and updated November 4th, 2022."
Answered by AI
How many people are volunteering to participate in this experiment?
"The planned clinical study will require 270 individuals that meet the inclusion criteria. The sponsor, RemeGen Co., Ltd.,will manage the trial from various locations - two of which are Charlotte's Levine Cancer Institute and Cleveland's Case Western Reserve University / University Hospitals Cleveland Medical Center."
Answered by AI
Is Disitamab vedotin a safe cancer treatment?
"Disitamab vedotin falls into Phase 2 of clinical testing, so there is some data suggesting it is safe for human use but no efficacy data yet."
Answered by AI
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