Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Nataliya Mar

Description

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.

Official Title

A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone and in Combination With Pembrolizumab in Subjects With Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2

Keywords

Urothelial Carcinoma, Urothelial Cancer, Bladder Cancer, HER2 Mutations, HER2 Overexpression, HER2 Amplification, Seattle Genetics, Carcinoma, Transitional Cell Carcinoma, Pembrolizumab, disitamab vedotin, DV monotherapy for HER2-positive tumor types, DV monotherapy for HER2-low tumor types

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

  • University of California Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • UCLA Medical Center / David Geffen School of Medicine accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UC Irvine

  • Nataliya Mar
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 16 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Seagen Inc.
ID
NCT04879329
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 270 study participants
Last Updated