JOURNAL ONKOLOGIE – STUDIE

ORIGAMA

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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05694013

Studienbeginn:
Februar 2023

Letztes Update:
24.04.2024

Wirkstoff:
Atezolizumab SC

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Hoffmann-La Roche

Collaborator:
-

Studienleiter

Clinical Trials
Study Director
Hoffmann-LaRoche

Kontakt

Reference Study ID Number: MO42720 https://forpatients.roche.com/
Kontakt:
Phone: 888-662-6728
E-Mail: global-roche-genentech-trials@gene.com» Kontaktdaten anzeigen

Studienlocations
(3 von 25)

Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg
63739 Aschaffenburg
(Bayern)
GermanyRekrutierend» Google-Maps

MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken
21680 Stade
(Niedersachsen)
GermanyRekrutierend» Google-Maps

Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis
53840 Troisdorf
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps

Helios Klinik Wuppertal; Medizinische Klinik I
42283 Wuppertal
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps

Concord Repatriation General Hospital; Oncology
2139 Sydney
AustraliaRekrutierend» Google-Maps

Sunshine Coast University Hospital; The Adem Crosby Centre
4575 Birtinya
AustraliaRekrutierend» Google-Maps

Monash Medical Centre Clayton
3168 Clayton
AustraliaRekrutierend» Google-Maps

Latrobe Regional Hospital
3844 Traralgon
AustraliaRekrutierend» Google-Maps

Lkh-Univ. Klinikum Graz
8036 Graz
AustriaRekrutierend» Google-Maps

Klinikum Klagenfurt am Wörtersee
9020 Klagenfurt am Worthersee
AustriaRekrutierend» Google-Maps

Klinikum Klagenfurt am Wörtersee; Abt.Gastroenterologie&Hepatologie,Endokrinologie
9020 Klagenfurt
AustriaRekrutierend» Google-Maps

Vestre Viken HF Drammen; Onkologisk avdeling
3019 Drammen
NorwayZurückgezogen» Google-Maps

Sykehuset Innlandet HF Gjøvik; Department of Oncology and Radiotherapy
2819 Gjøvik
NorwayZurückgezogen» Google-Maps

Akershus Universitetssykehus HF; Avdeling for forskning, Medisinsk divisjon
1478 Lørenskog
NorwayZurückgezogen» Google-Maps

Hospital Son Llatzer; Servicio de Oncologia
07198 Palma de Mallorca
SpainZurückgezogen» Google-Maps

Hospital Regional Universitario de Malaga; Oncologia
29010 Málaga
SpainRekrutierend» Google-Maps

Hospital del Mar; Servicio de Oncologia
08003 Barcelona
SpainAktiv, nicht rekrutierend» Google-Maps

Hospital Clínic i Provincial; Servicio de Hematología y Oncología
08036 Barcelona
SpainAktiv, nicht rekrutierend» Google-Maps

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
23007 Jaen
SpainAktiv, nicht rekrutierend» Google-Maps

Hospital General Universitario de Valencia; Servicio de oncologia
46014 Valencia
SpainZurückgezogen» Google-Maps

Hospital Universitario Miguel Servet; Servicio Oncologia
50009 Zaragoza
SpainZurückgezogen» Google-Maps

Hirslanden Medical Center - Tumorzentrum
5000 Aarau
SwitzerlandRekrutierend» Google-Maps

Hôpital Universitaire de Genève (HUG)
1211 Genève
SwitzerlandRekrutierend» Google-Maps

CHUV; Departement d'Oncologie
1011 Lausanne
SwitzerlandRekrutierend» Google-Maps

Stadtspital Triemli; Klinik für medizinische Onkologie und Hämatologie
8063 Zürich
SwitzerlandRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Mean difference in change of Week 12 value from baseline of participant-reported Total Symptom Interference Score from the MD Anderson Symptom Inventory (MDASI) Core Items (Cohort A) (Time Frame - Baseline, Week 12)

2. Percentage of participants with Flexcare adoption at Cycle 6 (Cohort B) (Time Frame - Cycle 6 (cycle length = 21 days))

Secondary outcome:

1. Number of hospitalizations due to serious adverse events (SAEs) (Cohort A) (Time Frame - Up to approximately 28 months)

2. Number of cumulative days hospitalized due to SAEs (Cohort A) (Time Frame - Up to approximately 28 months)

3. Number of unscheduled visits to the emergency room (ER) or clinic for symptom management (Cohort A) (Time Frame - Up to approximately 28 months)

4. Change from baseline in Global Health Status score/Quality of Life score (GHS/QoL) from the European Organisation for Research and Treatment of Cancer (EORTC) Item Library 6 (IL6) GHS/QoL (Cohort A) (Time Frame - Up to approximately 28 months)

5. Change from baseline in EuroQol EQ-5D-5L index-based instrument (Cohort A) (Time Frame - Up to approximately 28 months)

6. Change from baseline in EuroQol EQ-5D-5L Visual Analogue Scale (VAS) instrument (Cohort A) (Time Frame - Up to approximately 28 months)

7. Change from baseline in mean symptom severity score from the MDASI Core Items (Cohort A) (Time Frame - Up to approximately 28 months)

Studien-Arme

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.
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.
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.

Geprüfte Regime

Roche DPM Module:
Participants will be trained in the use of the Roche DPM Module, which they will use alongside local SOC support
Atezolizumab SC:
Participants will receive atezolizumab SC for 16 cycles (cycle length = 21 days)
Local SOC support:
Participants will receive local SOC support

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

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

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!