Open Actively Recruiting

A Study of Disitamab Vedotin Alone and With Pembrolizumab in Urothelial Cancer That Expresses HER2

About

Brief Summary

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Expected survival ≥12 weeks
  • Histologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra
  • Cohorts A and B: Participants must have received only 1 or 2 lines of prior systemic treatment for LA/mUC, including 1 line of platinum-containing chemotherapy
    • Neoadjuvant or adjuvant systemic therapy, with progression within 12 months of completing last dose of therapy, is considered a line of prior therapy.
    • Maintenance avelumab therapy delivered following first-line platinum therapy is not considered a separate line of therapy.
    • Prior therapy with PD-(L)1 inhibitors as (neo)adjuvant therapy, first-line maintenance therapy or as second-line treatment is allowed
  • Cohort C: No prior systemic therapy for LA/mUC
    • Neoadjuvant or adjuvant therapy, including PD-(L1) inhibitors, is acceptable, if disease recurrence/progression occurred more than 12 months after the last dose of systemic therapy
  • Cohorts A and B only: 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.
  • Cohort C only: Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation
  • Participants must be able to provide archived tumor tissue prior to treatment initiation. If archival tissue is not available, a baseline biopsy is required within 28 days of Cycle 1 Day 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:
    • Cohorts A and B: ECOG of 0 or 1
    • Cohort C: ECOG of 0, 1, or 2

Exclusion Criteria:

  • Known hypersensitivity to disitamab vedotin, pembrolizumab (in Cohort C), or any of their components
  • Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study
  • 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
  • Other malignant tumors within 3 years of study treatment, except for:
    • Prostate cancer treated with definitive intent (surgically or with radiation therapy) ≥ 1 year prior to treatment initiation is acceptable
    • Malignancies that can be cured after treatment

There are additional inclusion and exclusion criteria. The study center will determine if

criteria for participation are met.

Join this Trial

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Study Stats
Protocol No.
22-000981
Category
Hematology-Oncology
Oncology
Contact
KATHRYN B HILBURN
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04879329
For detailed technical eligibility, visit ClinicalTrials.gov.