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

Primary Purpose

Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Roche DPM Module
Atezolizumab SC
Local SOC support
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Remote Patient Monitoring, Digital Patient Monitoring, Symptom Monitoring, Digital Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Concord Repatriation General Hospital; OncologyRecruiting
  • Sunshine Coast University Hospital; The Adem Crosby CentreRecruiting
  • Monash Medical Centre ClaytonRecruiting
  • Latrobe Regional HospitalRecruiting
  • Lkh-Univ. Klinikum GrazRecruiting
  • Klinikum Klagenfurt am WörterseeRecruiting
  • Klinikum Klagenfurt am Wörtersee; Abt.Gastroenterologie&Hepatologie,EndokrinologieRecruiting
  • Hämato-Onkologische Schwerpunktpraxis am Klinikum AschaffenburgRecruiting
  • MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. HanckenRecruiting
  • Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische SchwerpunktpraxisRecruiting
  • Helios Klinik Wuppertal; Medizinische Klinik IRecruiting
  • Vestre Viken HF Drammen; Onkologisk avdeling
  • Sykehuset Innlandet HF Gjøvik; Department of Oncology and Radiotherapy
  • Akershus Universitetssykehus HF; Avdeling for forskning, Medisinsk divisjon
  • Hospital Son Llatzer; Servicio de OncologiaRecruiting
  • Hospital Regional Universitario de Malaga; OncologiaRecruiting
  • Hospital del Mar; Servicio de OncologiaRecruiting
  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología
  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de OncologiaRecruiting
  • Hospital General Universitario de Valencia; Servicio de oncologiaRecruiting
  • Hospital Universitario Miguel Servet; Servicio OncologiaRecruiting
  • Hirslanden Medical Center - TumorzentrumRecruiting
  • Hôpital Universitaire de Genève (HUG)Recruiting
  • CHUV; Departement d'OncologieRecruiting
  • Stadtspital Triemli; Klinik für medizinische Onkologie und HämatologieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort A - Arm 1

Cohort A - Arm 2

Cohort B

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

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)
Percentage of participants with Flexcare adoption at Cycle 6 (Cohort B)

Secondary Outcome Measures

Number of hospitalizations due to serious adverse events (SAEs) (Cohort A)
Number of cumulative days hospitalized due to SAEs (Cohort A)
Number of unscheduled visits to the emergency room (ER) or clinic for symptom management (Cohort A)
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)
Change from baseline in EuroQol EQ-5D-5L index-based instrument (Cohort A)
Change from baseline in EuroQol EQ-5D-5L Visual Analogue Scale (VAS) instrument (Cohort A)
Change from baseline in mean symptom severity score from the MDASI Core Items (Cohort A)

Full Information

First Posted
December 20, 2022
Last Updated
October 9, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT05694013
Brief Title
Clinical Impact and Utility of Digital Health Solutions in Participants Receiving Systemic Treatment in Clinical Practice
Acronym
ORIGAMA
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
July 7, 2024 (Anticipated)
Study Completion Date
July 7, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
Remote Patient Monitoring, Digital Patient Monitoring, Symptom Monitoring, Digital Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A - Arm 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort A - Arm 2
Arm Type
Experimental
Arm Description
Participants with mNSCLC, ES-SCLC, and HCC who are prescribed an anticancer regimen including IV atezolizumab will receive local SOC support.
Arm Title
Cohort B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Roche DPM Module
Intervention Description
Participants will be trained in the use of the Roche DPM Module, which they will use alongside local SOC support
Intervention Type
Drug
Intervention Name(s)
Atezolizumab SC
Intervention Description
Participants will receive atezolizumab SC for 16 cycles (cycle length = 21 days)
Intervention Type
Other
Intervention Name(s)
Local SOC support
Intervention Description
Participants will receive local SOC support
Primary Outcome Measure Information:
Title
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
Title
Percentage of participants with Flexcare adoption at Cycle 6 (Cohort B)
Time Frame
Cycle 6 (cycle length = 21 days)
Secondary Outcome Measure Information:
Title
Number of hospitalizations due to serious adverse events (SAEs) (Cohort A)
Time Frame
Up to approximately 28 months
Title
Number of cumulative days hospitalized due to SAEs (Cohort A)
Time Frame
Up to approximately 28 months
Title
Number of unscheduled visits to the emergency room (ER) or clinic for symptom management (Cohort A)
Time Frame
Up to approximately 28 months
Title
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
Title
Change from baseline in EuroQol EQ-5D-5L index-based instrument (Cohort A)
Time Frame
Up to approximately 28 months
Title
Change from baseline in EuroQol EQ-5D-5L Visual Analogue Scale (VAS) instrument (Cohort A)
Time Frame
Up to approximately 28 months
Title
Change from baseline in mean symptom severity score from the MDASI Core Items (Cohort A)
Time Frame
Up to approximately 28 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: MO42720 https://forpatients.roche.com/
Phone
888-662-6728
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-LaRoche
Official's Role
Study Director
Facility Information:
Facility Name
Concord Repatriation General Hospital; Oncology
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Individual Site Status
Recruiting
Facility Name
Sunshine Coast University Hospital; The Adem Crosby Centre
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Individual Site Status
Recruiting
Facility Name
Monash Medical Centre Clayton
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Name
Latrobe Regional Hospital
City
Traralgon
State/Province
Victoria
ZIP/Postal Code
3844
Country
Australia
Individual Site Status
Recruiting
Facility Name
Lkh-Univ. Klinikum Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Name
Klinikum Klagenfurt am Wörtersee
City
Klagenfurt am Worthersee
ZIP/Postal Code
9020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Klinikum Klagenfurt am Wörtersee; Abt.Gastroenterologie&Hepatologie,Endokrinologie
City
Klagenfurt
ZIP/Postal Code
9020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Individual Site Status
Recruiting
Facility Name
MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken
City
Stade
ZIP/Postal Code
21680
Country
Germany
Individual Site Status
Recruiting
Facility Name
Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis
City
Troisdorf
ZIP/Postal Code
53840
Country
Germany
Individual Site Status
Recruiting
Facility Name
Helios Klinik Wuppertal; Medizinische Klinik I
City
Wuppertal
ZIP/Postal Code
42283
Country
Germany
Individual Site Status
Recruiting
Facility Name
Vestre Viken HF Drammen; Onkologisk avdeling
City
Drammen
ZIP/Postal Code
3019
Country
Norway
Individual Site Status
Withdrawn
Facility Name
Sykehuset Innlandet HF Gjøvik; Department of Oncology and Radiotherapy
City
Gjøvik
ZIP/Postal Code
2819
Country
Norway
Individual Site Status
Withdrawn
Facility Name
Akershus Universitetssykehus HF; Avdeling for forskning, Medisinsk divisjon
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
Individual Site Status
Withdrawn
Facility Name
Hospital Son Llatzer; Servicio de Oncologia
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07198
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional Universitario de Malaga; Oncologia
City
Málaga
State/Province
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital del Mar; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario de Valencia; Servicio de oncologia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Miguel Servet; Servicio Oncologia
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hirslanden Medical Center - Tumorzentrum
City
Aarau
ZIP/Postal Code
5000
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Hôpital Universitaire de Genève (HUG)
City
Genève
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
CHUV; Departement d'Oncologie
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Stadtspital Triemli; Klinik für medizinische Onkologie und Hämatologie
City
Zürich
ZIP/Postal Code
8063
Country
Switzerland
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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

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