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Recruitment Complete
Astellas Study ID
7465-CL-1104

A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants with Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and programmed cell death protein-1 ( PD 1) / (programmed death ligand-1 (PD-L1) Inhibitor Therapy

Astellas Study ID
NCT04995419
Clinicaltrials.gov ID
NCT04995419
EUCTIS ID
N/A
EudraCT ID
N/A
jRCT ID
N/A
CN CDE ID
CTR20210922
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Study summary

The purpose of this study was to determine the antitumor activity of enfortumab vedotin (EV) confirmed by the objective response rate (ORR).

This study also evaluated the effect of antibody-drug conjugate (ADC), total antibody (TAb) and monomethyl auristatin E (MMAE) in Chinese participants with locally advanced or metastatic urothelial cancer.

In addition, the study also evaluated the duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and immunogenicity determined by the incidence of antitherapeutic antibodies (ATA).

Safety and tolerability of EV in participants with locally advanced or metastatic urothelial cancer was also evaluated.

Additional Study Details

Phase
Phase 2
Product
  • Enfortumab vedotin
    • Type
    Interventional
    Masking
    None (Open Label)
    Enrollment number
    40
    Show Additional Study Details

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    Would you like more information about clinical trial sites that are recruiting participants for A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants with Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and programmed cell death protein-1 ( PD 1) / (programmed death ligand-1 (PD-L1) Inhibitor Therapy? Contact us by filling out your information to the right and we’ll respond to you.

    • A caregiver
    • A healthcare provider
    • A parent
    • A patient
    • A patient advocate
    • Algeria
    • Argentina
    • Armenia
    • Australia
    • Austria
    • Belarus
    • Belgium
    • Bosnia And Herzegovina
    • Brazil
    • Bulgaria
    • Canada
    • Chile
    • China
    • Colombia
    • Croatia
    • Czech Republic
    • Denmark
    • Dominican Republic
    • Egypt
    • Estonia
    • Finland
    • Former Serbia and Montenegro
    • France
    • Georgia
    • Germany
    • Greece
    • Guatemala
    • Hong Kong
    • Hungary
    • Iceland
    • India
    • Indonesia
    • Ireland
    • Israel
    • Italy
    • Japan
    • Jordan
    • Kazakhstan
    • Latvia
    • Lebanon
    • Lithuania
    • Macedonia
    • Malaysia
    • Mexico
    • Montenegro
    • Morocco
    • Netherlands
    • New Zealand
    • Norway
    • Panama
    • Peru
    • Philippines
    • Poland
    • Portugal
    • Puerto Rico
    • Republic of Korea
    • Republic of Moldova
    • Romania
    • Russian Federation
    • Saudi Arabia
    • Serbia
    • Singapore
    • Slovakia
    • Slovenia
    • South Africa
    • Spain
    • Sweden
    • Switzerland
    • Taiwan, Province of China
    • Thailand
    • Turkey
    • Ukraine
    • United Kingdom
    • United States
    • Vietnam

    By clicking ["Continue/Submit"], you agree that Astellas may contact you by email with information to help you connect with clinical trial sites. While we can connect you to clinical trial sites, we cannot answer questions about any investigational therapy through email. Your consent to receiving emails is not a requirement to participate in a clinical trial or study. For more information, including how to unsubscribe at any time, see our Privacy Notice & Cookies Policy.

      Locations

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      Contact Us
      Active, not recruiting
      Site CN86001
      Beijing, China
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      Active, not recruiting
      Site CN86006
      Hangzhou, China
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      Completed
      Site CN86003
      Wuhan, China
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      Completed
      Site CN86007
      Nanjing, China
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      Completed
      Site CN86002
      Guangzhou, China
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      Completed
      Site CN86009
      Changsha, China
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      Withdrawn
      Site CN86011
      Shenyang, China
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      Completed
      Site CN86004
      Shanghai, China
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      Trial info
      Follow Trial
      Age
      18+ years
      Diamond icon
      Condition
    • Bladder Cancer
      • Gender icon
      Sex
      Female & Male
      Calendar icon
      Trial Dates
      Jul 2021 - May 2022
      Additional Study Details
      Inclusion Criteria

        Inclusion Criteria:

      • Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
      • Participant must have histologically or cytologically documented urothelial/transitional cell carcinoma of the bladder, renal pelvis, ureter or urethra. Other histologies including adenocarcinoma, squamous differentiation or mixed are eligible.
      • Participant has locally advanced or metastatic disease that is not amenable to curative intent treatment. Participants must have measurable disease at baseline according to Response Evaluation Criteria in Solid Tumors (RECIST) ( Version 1.1). Lesions in a prior radiation field must have progressed subsequent to radiotherapy to be considered measurable.
      • Participant must have received prior treatment with PD-1/PD-L1 inhibitor therapy in the locally advanced or metastatic urothelial cancer setting. Participants who received PD-1/PD-L1 therapy in the neoadjuvant/adjuvant setting and had recurrent or progressive disease either during therapy or within 3 months of therapy completion are eligible.
      • Participant who received prior treatment with platinum-containing chemotherapy defined as those who received platinum in the neoadjuvant/adjuvant setting and had recurrent or progressive disease within 12 months of completion or received treatment with platinum in the locally advanced (defined as unresectable with curative intent) or metastatic setting.
        • Platinum based chemotherapy may include combination use with a PD-1 or PD-L1 inhibitor.
      • Participant has the following baseline laboratory data. If a participant has received a recent blood transfusion or growth factor, the hematology tests must be obtained ≥7 days after any growth factor and ≥ 28 days after any blood transfusion.
        • absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L
        • platelet count ≥ 100 × 10^9/L
        • hemoglobin ≥ 9 g/dL
        • serum total bilirubin (TBL) ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for participants with Gilbert’s disease
        • creatinine clearance (CrCl) ≥ 30 mL/min as estimated per institutional standards or as measured by 24-hour urine collection (glomerular filtration rate [GFR] can also be used instead of CrCl).
        • alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN
      • Female participant is not pregnant and at least one of the following conditions apply:
        • Not a woman of childbearing potential (WOCBP)
        • WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after the last dose of study treatment administration.
      • Female participant must agree not to breastfeed starting at screening and throughout the study period and for at least 6 months after the last dose of study treatment administration.
      • Female participant must not donate ova starting at first dose of study treatment and throughout the study period and for 6 months after the last dose of study treatment administration.
      • Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 6 months after the last dose of study treatment administration.
      • Male participant must not donate sperm during the treatment period and for 6 months after the last dose of study treatment administration.
      • Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 6 months after the last dose of study treatment administration.
      • Participant agrees not to participate in another interventional study while receiving study treatment in the present study.
      • Participant must have had progression or recurrence of urothelial cancer during or following receipt of most recent therapy.
      • Participant must have an anticipated life expectancy of ≥ 3 months.

        • Exclusion Criteria:

      • Participant has preexisting sensory or motor neuropathy Grade ≥ 2.
      • Participant has active central nervous system (CNS) metastases. Participants with treated CNS metastases are permitted on study if all the following are true:
        • CNS metastases have been clinically stable for ≥ 6 weeks prior to screening.
        • If requiring steroid treatment for CNS metastases, the participant is on a stable dose ≤ 20 mg/day of prednisone or equivalent for ≥ 2 weeks.
        • Baseline imaging scans show no evidence of new or enlarged brain metastasis.
        • Participant does not have leptomeningeal disease.
      • Participant has ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery).
      • Participant with ongoing ≥ Grade 3 immunotherapy-related hypothyroidism or panhypopituitarism is excluded. Participant with ongoing immunotherapy-related colitis, uveitis, myocarditis or pneumonitis, or participants with other immunotherapy-related AEs requiring high doses of steroids (> 20 mg/day of prednisone or equivalent), is excluded. Participant with ≤ Grade 2 immunotherapy-related hypothyroidism or panhypopituitarism may be enrolled when well-maintained/controlled on a stable dose of hormone replacement therapy (if indicated).
      • Participant has a history of uncontrolled diabetes mellitus within 3 months before the first dose of study treatment. Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) ≥ 8 percent or HbA1c between 7 percent and < 8 percent with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
      • Participant has prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE)-based antibody-drug conjugate (ADCs).
      • Participant has a second malignancy diagnosed within 3 years before first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Participants with non-melanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low-risk (per standard guidelines) localized prostate cancer under active surveillance/watchful waiting without intent to treat, or carcinoma in situ of any type (if complete resection was performed) are allowed.
      • Participant is currently receiving systemic antimicrobial treatment for viral, bacterial or fungal infection at the time of first dose of study treatment. Routine antimicrobial prophylaxis is permitted.
      • Participants with a positive hepatitis B surface antigen and/or anti-hepatitis B core antibody and a negative polymerase chain reaction (PCR) assay at baseline should receive appropriate antiviral prophylaxis or regular

        • surveillance monitoring as per local or institutional guidelines.

      • Active hepatitis C infection or known human immunodeficiency virus (HIV) infection. Participant who have been treated for hepatitis C infection are permitted if they have documented sustained virologic response of ≥ 12 weeks.
      • Participant has documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class III-IV within 6 months prior to the first dose of study drug.
      • Participant had major surgery within 2 weeks or radiotherapy, chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy that is not completed 2 weeks prior to first dose of study drug. Toxicities from these therapies must have resolved or adequately stabilized before starting study treatment.
      • Participant has known hypersensitivity to enfortumab vedotin or to any excipient contained in the drug formulation of enfortumab vedotin (including histidine, trehalose dihydrate and polysorbate 20) or participant has known hypersensitivity to biopharmaceuticals produced in CHO cells.
      • Participant has known active keratitis or corneal ulcerations. Participant with superficial punctate keratitis is allowed if the disorder is being adequately treated.
      • Participant has any condition which makes the participant unsuitable for study participation.
      • Uncontrolled tumor-related bone pain or impending spinal cord compression. Participant requiring pain medication must be on a stable regimen for at least 2 weeks at the time of first dose.

      Frequently Asked Questions

      Are clinical trials only for people with advanced cancer?

      While some clinical trials may focus on more advanced cancers, many trials are open to patients at various stages of their cancer. Each study has rules about who can take part. For example, only patients in a certain age group or those who have a certain type of tumor may be able to join.

      Will I have to stop my current treatment to participate in a clinical trial?

      Sometimes researchers want participants to keep taking their current treatments during a clinical trial. Other times, you may need to stop your current treatments for a while. If the investigational treatment doesn't work, you can usually go back to your original treatment plan.

      Should I be worried about getting a placebo?

      In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

      Do I need a referral from my doctor to take part in a study?

      Your doctor may not know about all the opportunities for clinical trials that are available to you. Talk to your doctor or other medical provider about clinical trial information that you find. They can help you decide if a clinical trial is right for you. If you do not find any options on this website, we recommend you visit an online public registry website like clinicaltrials.gov to see a wide variety of available clinical trials.

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