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NCT05694013 | Recruiting | Cancer


Clinical Impact and Utility of Digital Health Solutions in Participants Receiving Systemic Treatment in Clinical Practice
Sponsor:

Hoffmann-La Roche

Brief Summary:

This study will evaluate the clinical impact and utility of digital health solutions (DHS) on health outcomes and health-care resource utilization in people receiving systemic anti-cancer treatment (approved or non-approved) in clinical practice.

Condition or disease

Cancer

Intervention/treatment

Roche DPM Module

Atezolizumab SC

Local SOC support

Phase

Phase 2

Phase 3

Study Type : Interventional
Estimated Enrollment : 440 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interventional Platform Study Investigating the Impact of Digital Health Solutions on Health Outcomes and Health-Care Resource Utilization in Participants Receiving Systemic Treatment in Clinical Practice
Actual Study Start Date : February 27, 2023
Estimated Primary Completion Date : July 7, 2024
Estimated Study Completion Date : July 7, 2026
Arm Intervention/treatment

Experimental: Cohort A - Arm 1

Participants with metastatic non-small cell lung carcinoma (mNSCLC), extensive-stage small-cell lung carcinoma (ES-SCLC), and advanced or unresectable hepatocellular carcinoma (HCC) and who are prescribed an anticancer regimen including intravenous (IV) atezolizumab will use the Roche Digital Patient Monitoring (DPM) Module along with local standard of care (SOC) support.

Device: Roche DPM Module

Experimental: Cohort A - Arm 2

Participants with mNSCLC, ES-SCLC, and HCC who are prescribed an anticancer regimen including IV atezolizumab will receive local SOC support.

Other: Local SOC support

Experimental: Cohort B

Participants with resected Stage IIB-IIIB NSCLC will use the Roche DPM Module along with subcutaneous (SC) atezolizumab in both the hospital and flexcare (home) setting.

Other: Local SOC support

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria: All Participants
  • Email address, access to an internet-capable device (smartphone, tablet, or PC), and access to an internet connection
  • Inclusion Criteria: Cohort A
  • Histologically confirmed diagnosis for mNSCLC, ES-SCLC, or HCC (Child Pugh A)
  • Systemic therapy naive
  • Prescribed an atezolizumab IV regimen
  • Easter Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • Inclusion Criteria: Cohort B
  • Complete resection of a histologically or cytologically confirmed Stage IIB-IIIB (T3-N2) NSCLC
  • PD-L1 positive
  • Have completed adjuvant chemotherapy at least 4 weeks and up to 12 weeks prior to randomization and must be adequately recovered from chemotherapy treatment
  • ECOG Performance Status of 0 or 1
  • Adequate hematologic and end-organ function
  • For participants receiving therapeutic anticoagulation: stable anticoagulant regimen
  • Negative for hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • Exclusion Criteria: All Participants
  • Any physical or cognitive condition that would prevent the participant from using the DHS
  • Participants not proficient with any of the available DHS language translations or with psychiatric/neurologic disorders or any condition that may impact the participant's ability to use the DPM solution
  • Currently participating in another interventional trial
  • History of malignancy within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death
  • Exclusion Criteria: Cohort A
  • Concomitant anti-cancer therapy at the time of starting atezolizumab (IV) regimen on the index date which is not part of a locally approved combination therapy with atezolizumab
  • Participants not receiving atezolizumab, but an atezolizumab biosimilar or non-comparable biologic
  • Participants currently using another DPM or ePRO solution for symptom management and/or reporting
  • Exclusion Criteria: Cohort B
  • Participants known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogene
  • Uncontrolled tumor-related pain
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
  • History of leptomeningeal disease
  • Uncontrolled or symptomatic hypercalcemia
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • Active tuberculosis
  • Significant cardiovascular disease
  • Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
  • Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could impact participant safety
  • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
  • Prior allogeneic stem cell or solid organ transplantation
  • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
  • Current treatment with anti-viral therapy for HBV
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
  • Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and IL-2) within 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
  • Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-α [TNF-α] agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
  • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
  • Pregnancy or breastfeeding
  • Known allergy or hypersensitivity to hyaluronidase, bee or vespid venom, or any other ingredient in the formulation of rHuPH20
  • Pathology (e.g., lower extremity edema, cellulitis, lymphatic disorder or prior surgery, preexisting pain syndrome, previous lymph node dissection, etc.) that could interfere with any protocol-specified outcome assessment
  • Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 2 weeks prior to randomization
  • Participants currently using another DPM or ePRO solution for symptom management and/or reporting

  • Clinical Impact and Utility of Digital Health Solutions in Participants Receiving Systemic Treatment in Clinical Practice

    Location Details


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    Clinical Impact and Utility of Digital Health Solutions in Participants Receiving Systemic Treatment in Clinical Practice

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations


    Recruiting

    Australia, New South Wales

    Concord Repatriation General Hospital; Oncology

    Sydney, New South Wales, Australia, 2139

    Recruiting

    Australia, Queensland

    Sunshine Coast University Hospital; The Adem Crosby Centre

    Birtinya, Queensland, Australia, 4575

    Recruiting

    Australia, Victoria

    Monash Medical Centre Clayton

    Clayton, Victoria, Australia, 3168

    Recruiting

    Australia, Victoria

    Latrobe Regional Hospital

    Traralgon, Victoria, Australia, 3844

    Recruiting

    Austria, Islas Baleares

    Lkh-Univ. Klinikum Graz

    Graz, Islas Baleares, Austria, 8036

    Recruiting

    Austria, Malaga

    Klinikum Klagenfurt am Wörtersee

    Klagenfurt am Worthersee, Malaga, Austria, 9020

    Recruiting

    Austria,

    Klinikum Klagenfurt am Wörtersee; Abt.Gastroenterologie&Hepatologie,Endokrinologie

    Klagenfurt, Austria, 9020

    Recruiting

    Germany,

    Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg

    Aschaffenburg, Germany, 63739

    Recruiting

    Germany,

    MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken

    Stade, Germany, 21680

    Recruiting

    Germany,

    Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis

    Troisdorf, Germany, 53840

    Recruiting

    Germany,

    Helios Klinik Wuppertal; Medizinische Klinik I

    Wuppertal, Germany, 42283

    Withdrawn

    Norway,

    Vestre Viken HF Drammen; Onkologisk avdeling

    Drammen, Norway, 3019

    Withdrawn

    Norway,

    Sykehuset Innlandet HF Gjøvik; Department of Oncology and Radiotherapy

    Gjøvik, Norway, 2819

    Withdrawn

    Norway,

    Akershus Universitetssykehus HF; Avdeling for forskning, Medisinsk divisjon

    Lørenskog, Norway, 1478

    Withdrawn

    Spain,

    Hospital Son Llatzer; Servicio de Oncologia

    Palma de Mallorca, Spain, 07198

    Recruiting

    Spain,

    Hospital Regional Universitario de Malaga; Oncologia

    Málaga, Spain, 29010

    Active, not recruiting

    Spain,

    Hospital del Mar; Servicio de Oncologia

    Barcelona, Spain, 08003

    Active, not recruiting

    Spain,

    Hospital Clínic i Provincial; Servicio de Hematología y Oncología

    Barcelona, Spain, 08036

    Active, not recruiting

    Spain,

    Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

    Jaen, Spain, 23007

    Withdrawn

    Spain,

    Hospital General Universitario de Valencia; Servicio de oncologia

    Valencia, Spain, 46014

    Withdrawn

    Spain,

    Hospital Universitario Miguel Servet; Servicio Oncologia

    Zaragoza, Spain, 50009

    Recruiting

    Switzerland,

    Hirslanden Medical Center - Tumorzentrum

    Aarau, Switzerland, 5000

    Recruiting

    Switzerland,

    Hôpital Universitaire de Genève (HUG)

    Genève, Switzerland, 1211

    Recruiting

    Switzerland,

    CHUV; Departement d'Oncologie

    Lausanne, Switzerland, 1011

    Recruiting

    Switzerland,

    Stadtspital Triemli; Klinik für medizinische Onkologie und Hämatologie

    Zürich, Switzerland, 8063

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