Digital monitoring of self-reported symptoms by patients treated with Cabozantinib plus Nivolumab for advanced clear-cell renal carcinoma: The CANIQOL multicentre study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Francois Baclesse

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Neoplasms [C04]

Trial duration

17 Jul 2025 → ongoing

Decision date (initial)

2025-06-04

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

IPSEN PHARMA

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To evaluate the impact of digital monitoring of self-reported symptoms (PROs-CTC-AEs) to adjust treatments management of patients treated with cabozantinib plus nivolumab for advanced clear-cell RCC in real life during the first 3 months of the combined treatment

Secondary objectives 14

1. To report regular follow-up of self-reported symptoms during the first 6 months of the combination
2. To evaluate the improvement of self-report symptoms after adjustment of the combined treatment
3. To characterize and evaluate regular follow-up of patients self-reported fatigue
4. To have a longitudinal assessment of general health-related quality of life (QoL) and pain
5. To assess the feasibility of regular follow-up of PROs in real life
6. To evaluate parameters that could have an impact on compliance of treatments
7. To evaluate the duration of the treatment
8. To assess the clinical outcomes of the cabozantinib plus nivolumab association, in terms of objective response rate and overall response rate 3 and 6 months after the initiation of the combination
9. To assess the PFS according to treatment adjustments
10. To collect the satisfaction of patients and physicians of digital follow-up at 3 and 6 months
11. To evaluate the tolerability among a subgroup of frail elderly patients
12. To perform sub-group analyses taking into account the IMDC (International Metastatic Renal Cell Carcinoma Database Consortium) criteria
13. - To characterize and describe warning adverse reactions that may require therapeutic adaptation
14. - To characterize alerts issued by digital monitoring (frequency, impact on dose adjustment, treatment discontinuation, etc.)

Conditions and MedDRA coding

kidney cancer

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patient older than 18 years
2. Diagnosis of Renal Cell Carcinoma (RCC) with a clear-cell component
3. No prior systemic treatment for RCC
4. Physician-initiated decision prior to study enrollment to treat with cabozantinib and nivolumab in combination, according to approved local labels
5. Subjects affiliated to an appropriate social security system
6. Patient has signed informed consents obtained before any trial related activities and according to local guidelines

Exclusion criteria 7

1. Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
2. Current participation in another clinical study and/or in an investigational program with any intervention that could possibly interfere with the treatment and impact this study
3. Patient with history of allergy or hypersensitivity to components of the study drugs
4. Patient with contraindication to the study drugs
5. Pregnant or lactating woman
6. Patient unable to use digital tools
7. Patient deprived of liberty or placed under the authority of a tutor

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the adjustment of treatments management including any unplanned action guided by weekly digital monitoring of PRO-CTCAEs: anticipated consultation, anticipated phone follow-up, anticipated advices, treatment discontinuation, hospitalization within the first 3 months of the combined treatment

Investigational products

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

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Francois Baclesse

Sponsor organisation

Centre Francois Baclesse

Address

3 Avenue Du General Harris, Cs 45026 Cs 45026

City

Caen Cedex 5

Postcode

14076

Country

France

Scientific contact point

Organisation

Centre Francois Baclesse

Contact name

Florence JOLY LOBBEDEZ

Public contact point

Organisation

Centre Francois Baclesse

Contact name

Florence JOLY LOBBEDEZ

Locations

1 EU/EEA country · 16 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

Documents 22 files

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

Application history

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