Clinical Trials /

A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection

NCT02450331

Description:

This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants will be randomized by a 1:1 ratio into atezolizumab group or control group.

Related Conditions:
  • Bladder Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

A Phase III Study of <span class="go-doc-concept go-doc-intervention">Atezolizumab</span> Treatment Versus Observation as Adjuvant Therapy in Patients With PD-L1 Positive, High Risk Muscle Invasive Bladder Cancer After Cystectomy [IMvigor010]

Title

  • Brief Title: A Phase III Study of Atezolizumab Treatment Versus Observation as Adjuvant Therapy in Patients With PD-L1 Positive, High Risk Muscle Invasive Bladder Cancer After Cystectomy [IMvigor010]
  • Official Title: A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Versus Observation as Adjuvant Therapy in Patients With PD-L1-Selected, High-Risk Muscle-Invasive Bladder Cancer After Cystectomy
  • Clinical Trial IDs

    NCT ID: NCT02450331

    ORG ID: WO29636

    NCI ID: 2014-005603-25

    Trial Conditions

    Bladder Cancer, Cancer

    Trial Interventions

    Drug Synonyms Arms
    Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody Atezolizumab (MPDL3280A) Treatment

    Trial Purpose

    This study is to evaluate the efficacy and safety of adjuvant treatment with Atezolizumab
    compared with observation in participants with PD-L1-selected muscle-invasive bladder cancer
    (MIBC) who are at high risk for recurrence following cystectomy.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Atezolizumab (MPDL3280A) Treatment Experimental 1200 mg MPDL3280A administered intravenously (i.v.) once every 3 weeks for 16 cycles or 1 year Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
    Observation No Intervention Observation once every 3 weeks for 16 cycles or 1 year alternating clinic visit/phone call

    Eligibility Criteria

    Inclusion Criteria:

    - Age >/= 18 years

    - Histologically or cytologically confirmed muscle-invasive TCC of the bladder
    (excluding TCC of renal pelvis, ureters, or urethra) which is PD-L1 positive

    - For patients who have not received prior neoadjuvant chemotherapy, refusal of or
    ineligibility for cisplatin-based adjuvant chemotherapy

    - Representative tumor specimens as specified by the protocol

    - Absence of residual disease and absence of metastasis, as confirmed by a negative
    baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan of the
    pelvis, abdomen, and chest no more than 6 weeks prior to randomization

    - Full recovery from cystectomy within 12 weeks following surgery

    - Eastern Cooperative Oncology Group (ECOG) performance status of </= 2

    - Life expectancy >/= 12 weeks

    - Adequate hematologic and end-organ function

    - For women who are not postmenopausal or surgically sterile: agreement to remain
    abstinent or use single or combined contraceptive methods that result in a failure
    rate of <1% per year during the treatment period and for at least 90 days after the
    last dose of study drug

    Exclusion Criteria:

    - Any approved anti-cancer therapy within 3 weeks prior to initiation of study
    treatment

    - Adjuvant chemotherapy or radiation therapy for urothelial carcinoma (UC) following
    cystectomy

    - Treatment with any other investigational agent or participation in another clinical
    trial with therapeutic intent within 28 days prior to enrollment

    - Malignancies other than UC within 5 years prior to Cycle 1, Day 1

    - Pregnancy or breastfeeding

    - Significant cardiovascular disease

    - Severe infections within 4 weeks prior to randomization

    - Major surgical procedure other than for diagnosis within 4 weeks prior to
    randomization

    - History of severe allergic, anaphylactic, or other hypersensitivity reactions to
    chimeric or humanized antibodies or fusion proteins; known hypersensitivity or
    allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any
    component of the MPDL3280A formulation

    - History of autoimmune disease

    - Prior allogeneic stem cell or solid organ transplant

    - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
    pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
    chest CT scan

    - Positive test for HIV and/or active hepatitis B or hepatitis C or tuberculosis

    - Administration of a live, attenuated vaccine within 4 weeks prior to randomization

    - Prior treatment with CD137 agonists or immune checkpoint blockade therapies,
    including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Disease-Free Survival (DFS)

    Secondary Outcome Measures

    Overall Survival (OS)

    Disease-Specific Survival (DSS)

    Distant Metastasis-Free Survival (DMFS)

    Number of Participants with Adverse Events (AEs)

    Percentage of Anti-Therapeutic Antibody (ATA) Response to Atezolizumab

    Maximum Observed Serum Atezolizumab Concentration (Cmax)

    Score of Participant-Reported Health Status in the EuroQol 5-Dimension, 5-Level Version (EQ-5D-5L) Questionnaire

    Trial Keywords