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 (ORIGAMA)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

F. Hoffmann-La Roche AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

2 Feb 2023 → 1 Jul 2024

Decision date (initial)

2024-02-27

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

F. Hoffmann-La Roche AG

External identifiers

EU CT number

2023-504342-55-00

EudraCT number

2021-001415-90

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Cohort A
• To demonstrate superiority of the Roche digital patient monitoring (DPM) atezolizumab Module on symptom interference
Cohort B
• To evaluate the feasibility of combining the Roche DPM Atezolizumab Module and Atezolizumab subcutaneous (SC) administered in the at home treatment setting

Secondary objectives 3

1. Cohort A To assess the impact of the Roche DPM atezolizumab Module on number of hospitalizations and number of cumulative days hospitalized due to SAEs, unscheduled visits to the ER or clinic visits for symptom management, incidence, nature, and severity of all anti-cancer treatment associated AEs with additional analyses on Grade >= 3 AEs, SAEs, selected immune-related adverse events, Weighted toxicity score (WTS), interruption, modification, or discontinuation of atezolizumab regimen due to AEs, change from baseline in Global Health Status score/Quality of Life score (GHS/QoL) from the EORTC IL6 GHS/QoL, in EuroQol EQ-5D-5L index-based and visual analogue scale (VAS) instrument and in the mean symptom severity score from the MD Anderson Symptoms Inventory (MDASI) Core Items To assess the safety of the Roche DPM atezolizumab Module compared with local standard of care (SOC) support
2. Cohort B Number of hospitalizations within one day of Atezolizumab SC administration due to SAEs
3. Cohort B Incidence, nature, and severity of all Atezolizumab SC associated AEs graded according to the NCI-CTCAE v5.0 with additional analyses

Conditions and MedDRA coding

Cohort A: • Metastatic non-small cell lung carcinoma (mNSCLC) • Extensive-stage small-cell lung carcinoma (ES-SCLC) • Advanced or unresectable hepatocellular carcinoma (HCC) Cohort B: • Resected Stage IIB-IIIB (early-stage; per the UICC/AJCC staging system, 8th edition) non-small cell lung carcinoma (NSCLC)

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Participant has an email address, access to an internet-capable device, and access to an internet connection
2. Cohort A Participants must have a histologically confirmed diagnosis via local labs
3. Cohort A Eastern cooperative oncology group (ECOG) performance status of 0, 1, or 2 Cohort B ECOG Performance Status of 0 or 1
4. Cohort A Life expectancy >= 12 weeks
5. Cohort B Participants must have a complete resection of a histologically or cytologically confirmed Stage IIB-IIIB (T3-N2) non-small cell lung carcinoma (NSCLC)
6. Cohort B Programmed cell death-ligand 1 (PD-L1) positive as documented through local testing performed per manufacturer’s recommendations and requirements of a representative tumor tissue specimen. An appropriate CE marked or In-Vitro Diagnostics Device approved test should be used for local testing of PD-L1.

Exclusion criteria 6

1. Participants with any physical or cognitive condition that, according to clinical judgment, would prevent the participant from using the Digital Health Solution (DHS)
2. 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 DHS
3. Participants currently enrolled in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study
4. 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 as per summary of product characteristics (SmPC) or local regulatory documents
5. Cohort B Participants known to have a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene
6. Cohort B 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, such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 1. Mean difference in change of Week 12 value from baseline of the participant-reported Total Symptom Interference Score from the MD Anderson Symptom Inventory (MDASI) Core Items
2. 2. At-home treatment adoption at Cycle 6

Secondary endpoints 9

1. 1. Number of hospitalizations and number of cumulative days hospitalized due to serious adverse events (SAEs)
2. 2. Unscheduled visits to the emergency room (ER) or clinic visits for symptom management
3. 3. Incidence, nature, and severity of all anti-cancer treatment associated adverse event (AEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 with additional analyses on Grade >= 3 AEs, Serious adverse events (SAEs), selected immune-related adverse events, weighted toxicity score (WTS), interruption, modification, or discontinuation of atezolizumab regimen due to AEs
4. 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
5. 5. Change from baseline in EuroQoL 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) index-based and visual analogue Scale (VAS) instrument
6. 6. Change from baseline in the mean symptom severity score from the MDASI Core Items
7. 7. Incidence and severity of adverse events assessed as related to device use and adverse device effects
8. 8. Incidence, nature, and severity of anti-cancer treatment associated AEs as described in the secondary efficacy objectives
9. 9. Incidence, nature, and severity of all Atezolizumab SC associated AEs graded according to the NCI-CTCAE v5.0 with additional analyses on: - Grade ≥ 3 AEs - SAEs

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation

F. Hoffmann-La Roche AG

Address

Grenzacherstrasse 124

City

Basel

Postcode

4058

Country

Switzerland

Scientific contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Public contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Third parties 4

Locations

3 EU/EEA countries · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications