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A Study of Disitamab Vedotin Alone or with Pembrolizumab in Urothelial Cancer That Expresses HER2
EU CTIS ID: 2022-500030-28-01
What this study is testing
To evaluate the efficacy as measured by cORR assessed by BICR for disitamab vedotin monotherapy in previously treated participants with LA/mUC that expresses HER2 (HER2-positive [IHC 3+, or IHC 2+ and ISH-positive], and HER2-low [IHC 2+ and ISH-negative, or IHC 1+]) To evaluate the efficacy as measured by cORR assessed by BICR for disitamab vedotin alone and combined with pembrolizumab in treatment-naive participants with LA/mUC that expresses HER2
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Expected survival ≥12 weeks
- Locally-advanced unresectable or metastatic (American Joint Commission on Cancer Stages TNM Stage IIIB–IV [Amin 2017]) UC with histopathological confirmation, including UC originating from the renal pelvis, ureters, bladder, or urethra. Mixed-cell type tumors are eligible as long as urothelial (transitional cell) carcinoma is the predominant cell type.
- Prior therapy: a.Participantsmust have received only 1 or 2 lines of prior systemic therapy for LA/mUC, including 1 line of platinum-containing chemotherapy. i.Neoadjuvant or adjuvant systemic therapy, with progression within 12 months of completing final dose of therapy, is considered as one line of prior therapy. ii.Maintenance avelumab therapy delivered following first-line platinum therapy is not considered a separate line of therapy. iii.Prior therapy with PD-(L)1 inhibitors as (neo)adjuvant therapy, first-line maintenance therapy or as second-line treatment is allowed.
- Radiographically documented disease progression during or after the most recent line of therapy for LA/mUC
- At least one measurable lesion by investigator assessment based on RECIST version 1.1.
- Participants must be willing and able to provide archived (formalin-fixed paraffin-embedded tumor tissue blocks (or alternatively freshly sectioned slides; see laboratory manual for details and Section 7.1.3). This must be obtained prior to study treatment initiation and will be sent to a sponsor-designated central laboratory for biomarker analysis. If archival tissue is not available, then a newly obtained baseline biopsy of an accessible tumor lesion is required within 28 days prior to the Cycle 1 Day 1. Biopsy must provide adequate tissue for HER2 testing.
You likely can't join if
- Known hypersensitivity to disitamab vedotin or any of their components
- Received antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) or participated in another clinical study within 2 weeks prior to the start of the study (defined as Cycle 1 Day 1 for Cohorts A and B)
- Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
- Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy
- Major surgery that has not fully recovered within 4 weeks prior to dose administration
- Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline
See the full eligibility criteria
- Expected survival ≥12 weeks
- Locally-advanced unresectable or metastatic (American Joint Commission on Cancer Stages TNM Stage IIIB–IV [Amin 2017]) UC with histopathological confirmation, including UC originating from the renal pelvis, ureters, bladder, or urethra. Mixed-cell type tumors are eligible as long as urothelial (transitional cell) carcinoma is the predominant cell type.
- Prior therapy: a.Participantsmust have received only 1 or 2 lines of prior systemic therapy for LA/mUC, including 1 line of platinum-containing chemotherapy. i.Neoadjuvant or adjuvant systemic therapy, with progression within 12 months of completing final dose of therapy, is considered as one line of prior therapy. ii.Maintenance avelumab therapy delivered following first-line platinum therapy is not considered a separate line of therapy. iii.Prior therapy with PD-(L)1 inhibitors as (neo)adjuvant therapy, first-line maintenance therapy or as second-line treatment is allowed.
- Radiographically documented disease progression during or after the most recent line of therapy for LA/mUC
- At least one measurable lesion by investigator assessment based on RECIST version 1.1.
- Participants must be willing and able to provide archived (formalin-fixed paraffin-embedded tumor tissue blocks (or alternatively freshly sectioned slides; see laboratory manual for details and Section 7.1.3). This must be obtained prior to study treatment initiation and will be sent to a sponsor-designated central laboratory for biomarker analysis. If archival tissue is not available, then a newly obtained baseline biopsy of an accessible tumor lesion is required within 28 days prior to the Cycle 1 Day 1. Biopsy must provide adequate tissue for HER2 testing.
- HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, on the provided tumor tissue sample of muscle-invasive or metastatic UC.
- Participants must have an ECOG performance status of 0 or 1.
- Known hypersensitivity to disitamab vedotin or any of their components
- Received antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) or participated in another clinical study within 2 weeks prior to the start of the study (defined as Cycle 1 Day 1 for Cohorts A and B)
- Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
- Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy
- Major surgery that has not fully recovered within 4 weeks prior to dose administration
- Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline
- Received live or live-attenuated vaccines within 4 weeks prior to study treatment initiation or plan on receiving such vaccines during the course of study treatment
- Participants with acute, chronic or symptomatic infections, including: A. Ongoing symptoms of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. B. History of human immunodeficiency virus infection. C. History of hepatitis B virus (HBV) infection (defined as positive for HBV surface antigen) or known active hepatitis C virus (HCV) infection (defined as HCV RNA [qualitative] is detected).
- Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, or uncontrolled diabetes.
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- United States
- Turkey
- Canada
- Japan
- Australia
- Chile
- United Kingdom
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; United States; Turkey; Canada; Japan; Australia and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.