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CancerPhase 2/3ORIGAMANCT05694013

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

A Phase 2/3 study testing Roche DPM Module, Atezolizumab SC and Local SOC support in people with Cancer, run by Hoffmann-La Roche at 14 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Roche DPM Module, Atezolizumab SC and Local SOC support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
14 sitesin 5 countries
Study dates
27 Feb 2023to 30 Jun 2024
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Email address, access to an internet-capable device (smartphone, tablet, or PC), and access to an internet connection
  • 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
  • Complete resection of a histologically or cytologically confirmed Stage IIB-IIIB (T3-N2) NSCLC
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  • 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)

Who cannot join

  • 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
  • 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
Show all 33Show fewer
  • Participants currently using another DPM or ePRO solution for symptom management and/or reporting
  • 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

Trial locations and contacts

14 sites in 5 countries.

14 sites in 5 countries

Australia4 sites

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575

  • Monash Medical Centre Clayton

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital

    Sydney, New South Wales, 2139

  • Latrobe Regional Hospital

    Traralgon, Victoria, 3844

Other trials in Australia

Germany3 sites

  • Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg

    Aschaffenburg, 63739

  • MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -

    Stade, 21680

  • Helios Klinik Wuppertal

    Wuppertal, 42283

Other trials in Germany

Spain3 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Clínic i Provincial

    Barcelona, 08036

  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico

    Jaén, 23007

Other trials in Spain

Austria2 sites

  • Lkh-Univ. Klinikum Graz

    Graz, 8036

  • Klinikum Klagenfurt am Wörtersee

    Klagenfurt, 9020

Other trials in Austria

Switzerland2 sites

  • Hôpital Universitaire de Genève (HUG)

    Geneva, 1211

  • CHUV

    Lausanne, 1011

Other trials in Switzerland

About this study

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

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.

Conditions
Cancer
Being tested
Roche DPM Module, Atezolizumab SC, Local SOC support
Keywords
Remote Patient Monitoring, Digital Patient Monitoring, Symptom Monitoring, Digital Health
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Roche DPM ModuleDevice

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

  • Atezolizumab SCDrug

    Participants will receive atezolizumab SC for 16 cycles (cycle length = 21 days)

  • Local SOC supportOther

    Participants will receive local SOC support

Study groups in NCT05694013
Study groupRoleWhat they receive
Cohort A - Arm 1ExperimentalParticipants 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.
Receives: Device: Roche DPM Module; Other: Local SOC support
Cohort A - Arm 2ExperimentalParticipants with mNSCLC, ES-SCLC, and HCC who are prescribed an anticancer regimen including IV atezolizumab will receive local SOC support.
Receives: Other: Local SOC support
Cohort BExperimentalParticipants 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.
Receives: Device: Roche DPM Module; Drug: Atezolizumab SC

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    The MDASI assesses symptom severity and symptom interference with different aspects of a patient's life as rated by the patient. For 6 items (pertaining to patient's general activity, walking, work, mood, relations with other people and enjoyment of life), patients rate how the symptoms interfere with different aspects of their life in the last 7 days. The MDASI items are rated from 0-10, with 0 indicating that the symptom is either not present or does not interfere with the patient's activities and 10 indicating that the symptom is "as bad as you can imagine" or "interfered completely" with the patient's life.

    Measured: Baseline, Week 12

Secondary outcomes (4)

  1. 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

    The European Organisation for Research and Treatment of Cancer quality of life core questionnaire (EORTC QLQ-C30) consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), global health status (GHS) and quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. The EORTC item library 6 (IL6) GHS/QoL consists of only the GHS and QoL items from the EORTC QLQ-C30. The raw score is calculated as the value of both answers, scored on a 7-point scale that ranges from 1 ("very poor") to 7 ("excellent"), then a linear transformation is applied to produce a score between 0-100. Higher scores indicate a higher QoL.

    Measured: Baseline, Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Long Term Follow Up/Week 28 (cycle length = 21 days)

  2. Change From Baseline in the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Instrument

    The EQ-5D-5L is used to calculate a health status utility score for use in health economic analyses. The questionnaire is designed to capture the participant's current health status. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. The score range is 0-100, with higher scores indicating better outcomes.

    Measured: Baseline, Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Long Term Follow Up/Week 28 (cycle length = 21 days)

  3. Change From Baseline in Mean Symptom Severity Score From the MDASI Core Items

    The MDASI assesses symptom severity and symptom interference with different aspects of a patient's life as rated by the patient. For 6 items (pertaining to patient's general activity, walking, work, mood, relations with other people and enjoyment of life), patients rate how the symptoms interfere with different aspects of their life in the last 7 days. The MDASI items are rated from 0-10, with 0 indicating that the symptom is either not present or does not interfere with the patient's activities and 10 indicating that the symptom is "as bad as you can imagine" or "interfered completely" with the patient's life.

    Measured: Baseline, Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Long Term Follow Up/Week 28 (cycle length = 21 days)

  4. Number of Cumulative Days Hospitalized Due to SAEs

    Measured: Up to approximately 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2023
  2. Study start27 Feb 2023
  3. Primary completion30 Jun 2024
  4. Study completion30 Jun 2024

Why it stopped: Study terminated by sponsor.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05694013
Sponsor's protocol ID
MO42720
Acronym
ORIGAMA
Status last verified
Oct 2025
First submitted
20 Dec 2022
Last updated
22 Oct 2025
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Publications

  • Iivanainen S, Baird AM, Balas B, Bustillos A, Castro Sanchez AY, Eicher M, Golding S, Mueller-Ohldach M, Reig M, Welslau M, Ammann J. Assessing the impact of digital patient monitoring on health outcomes and healthcare resource usage in addition to the feasibility of its combination with at-home treatment, in participants receiving systemic anticancer treatment in clinical practice: protocol for an interventional, open-label, multicountry platform study (ORIGAMA). BMJ Open. 2023 Apr 19;13(4):e063242. doi: 10.1136/bmjopen-2022-063242.

    PubMed 37076159

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Roche DPM Module, Atezolizumab SC and Local SOC support in people with Cancer, run by Hoffmann-La Roche at 14 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Australia, Germany, Spain, Austria, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05694013, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.

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