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

Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05694013
• Other study ID #: MO42720
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: February 27, 2023
• Est. completion date: July 7, 2026

Study information

• Verified date: June 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 440
• Est. completion date: July 7, 2026
• Est. primary completion date: July 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-a [TNF-a] 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

Related Conditions & MeSH terms

• Cancer

Intervention

Device:
• Roche DPM Module
Participants will be trained in the use of the Roche DPM Module, which they will use alongside local SOC support

Drug:
• Atezolizumab SC
Participants will receive atezolizumab SC for 16 cycles (cycle length = 21 days)

Other:
• Local SOC support
Participants will receive local SOC support

Locations

Country	Name	City	State
Australia	Sunshine Coast University Hospital; The Adem Crosby Centre	Birtinya	Queensland
Australia	Monash Medical Centre Clayton	Clayton	Victoria
Australia	Concord Repatriation General Hospital; Oncology	Sydney	New South Wales
Australia	Latrobe Regional Hospital	Traralgon	Victoria
Austria	Lkh-Univ. Klinikum Graz	Graz
Austria	Klinikum Klagenfurt am Wörtersee; Abt.Gastroenterologie&Hepatologie,Endokrinologie	Klagenfurt
Austria	Klinikum Klagenfurt am Wörtersee	Klagenfurt am Worthersee
Germany	Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg	Aschaffenburg
Germany	MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken	Stade
Germany	Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis	Troisdorf
Germany	Helios Klinik Wuppertal; Medizinische Klinik I	Wuppertal
Spain	Hospital Clínic i Provincial; Servicio de Hematología y Oncología	Barcelona
Spain	Hospital del Mar; Servicio de Oncologia	Barcelona
Spain	Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia	Jaen
Spain	Hospital Regional Universitario de Malaga; Oncologia	Málaga	Malaga
Switzerland	Hôpital Universitaire de Genève (HUG)	Genève
Switzerland	CHUV; Departement d'Oncologie	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Australia,  Austria,  Germany,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		Baseline, Week 12
Primary	Percentage of participants with Flexcare adoption at Cycle 6 (Cohort B)		Cycle 6 (cycle length = 21 days)
Secondary	Number of hospitalizations due to serious adverse events (SAEs) (Cohort A)		Up to approximately 28 months
Secondary	Number of cumulative days hospitalized due to SAEs (Cohort A)		Up to approximately 28 months
Secondary	Number of unscheduled visits to the emergency room (ER) or clinic for symptom management (Cohort A)		Up to approximately 28 months
Secondary	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)		Up to approximately 28 months
Secondary	Change from baseline in EuroQol EQ-5D-5L index-based instrument (Cohort A)		Up to approximately 28 months
Secondary	Change from baseline in EuroQol EQ-5D-5L Visual Analogue Scale (VAS) instrument (Cohort A)		Up to approximately 28 months
Secondary	Change from baseline in mean symptom severity score from the MDASI Core Items (Cohort A)		Up to approximately 28 months