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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05694013




Registration number
NCT05694013
Ethics application status
Date submitted
20/12/2022
Date registered
23/01/2023

Titles & IDs
Public title
Clinical Impact and Utility of Digital Health Solutions in Participants Receiving Systemic Treatment in Clinical Practice
Scientific 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
Secondary ID [1] 0 0
MO42720
Universal Trial Number (UTN)
Trial acronym
ORIGAMA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Roche DPM Module
Treatment: Drugs - Atezolizumab SC
Other interventions - Local SOC support

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.


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

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

Other interventions: Local SOC support
Participants will receive local SOC support
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Baseline, Week 12
Primary outcome [2] 0 0
Percentage of participants with Flexcare adoption at Cycle 6 (Cohort B)
Timepoint [2] 0 0
Cycle 6 (cycle length = 21 days)
Secondary outcome [1] 0 0
Number of hospitalizations due to serious adverse events (SAEs) (Cohort A)
Timepoint [1] 0 0
Up to approximately 28 months
Secondary outcome [2] 0 0
Number of cumulative days hospitalized due to SAEs (Cohort A)
Timepoint [2] 0 0
Up to approximately 28 months
Secondary outcome [3] 0 0
Number of unscheduled visits to the emergency room (ER) or clinic for symptom management (Cohort A)
Timepoint [3] 0 0
Up to approximately 28 months
Secondary outcome [4] 0 0
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)
Timepoint [4] 0 0
Up to approximately 28 months
Secondary outcome [5] 0 0
Change from baseline in EuroQol EQ-5D-5L index-based instrument (Cohort A)
Timepoint [5] 0 0
Up to approximately 28 months
Secondary outcome [6] 0 0
Change from baseline in EuroQol EQ-5D-5L Visual Analogue Scale (VAS) instrument (Cohort A)
Timepoint [6] 0 0
Up to approximately 28 months
Secondary outcome [7] 0 0
Change from baseline in mean symptom severity score from the MDASI Core Items (Cohort A)
Timepoint [7] 0 0
Up to approximately 28 months

Eligibility
Key inclusion criteria
All Participants

* Email address, access to an internet-capable device (smartphone, tablet, or PC), and access to an internet connection

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

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/07/2024
Sample size
Target
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital; Oncology - Sydney
Recruitment hospital [2] 0 0
Sunshine Coast University Hospital; The Adem Crosby Centre - Birtinya
Recruitment hospital [3] 0 0
Monash Medical Centre Clayton - Clayton
Recruitment hospital [4] 0 0
Latrobe Regional Hospital - Traralgon
Recruitment postcode(s) [1] 0 0
2139 - Sydney
Recruitment postcode(s) [2] 0 0
4575 - Birtinya
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3844 - Traralgon
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Klagenfurt am Worthersee
Country [3] 0 0
Austria
State/province [3] 0 0
Klagenfurt
Country [4] 0 0
Germany
State/province [4] 0 0
Aschaffenburg
Country [5] 0 0
Germany
State/province [5] 0 0
Stade
Country [6] 0 0
Germany
State/province [6] 0 0
Troisdorf
Country [7] 0 0
Germany
State/province [7] 0 0
Wuppertal
Country [8] 0 0
Spain
State/province [8] 0 0
Malaga
Country [9] 0 0
Spain
State/province [9] 0 0
Barcelona
Country [10] 0 0
Spain
State/province [10] 0 0
Jaen
Country [11] 0 0
Switzerland
State/province [11] 0 0
Genève
Country [12] 0 0
Switzerland
State/province [12] 0 0
Lausanne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-LaRoche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: MO42720 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05694013