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MelanomaMONITORNCT04605146

Impact of Telemonitoring for the Management of Side Effects in Patients with Melanoma, Lung or Renal Cancer, Treated with Immunotherapy Combination of Nivolumab and Ipilimumab or Adjuvant Nivolumab Monotherapy

A study testing Tele-monitoring in people with Melanoma and Lung Cancer, run by Hospices Civils de Lyon at 10 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The ipilimumab and nivolumab combination is now part of the standard of care for the treatment of melanoma, renal and lung cancer patients. Grade 3/4 adverse events (AEs) occur in 30 to 60% of patients included in clinical trials. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma, Lung Cancer, Renal Cancer
What is being tested?
Tele-monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
10 sitesFrance
Study dates
5 May 2021to 5 Nov 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Age > 18 years
  • Patients diagnosed with melanoma, or lung cancer or renal cancer
  • Patients starting a treatment with a combination of immunotherapy of nivolumab + ipilimumab (NB: patients who have already received immunotherapy in the past may be included)
  • Patients comfortable with the use of digital tools and computing
  • Patients who agree to participate to the telemonitoring and signed consent form

Who cannot join

  • Pregnant, parturient and lactating women
  • Patients under legal protection measure or deprived of their liberty
  • Patients not affiliated to a social security scheme (schemes such as the AME) or beneficiaries of a similar regime (foreign person, outside the EU)

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Stéphane DALLE contact

0478861679 ext. +33

stephane.dalle@chu-lyon.fr

Aurélie RABIER contact

0478861679 ext. +33

aurelie.rabier@chu-lyon.fr

10 sites in 1 country

France10 sites, 9 recruiting

  • Groupement hospitalier Est - Multidisciplinary oncological platform

    Bron

    Christophe SAJOUS, MD, 0427856577 ext. +33, christophe.sajous@chu-lyon.fr

    Christophe SAJOUS, MD

    Not yet recruiting

  • Hôpital Louis Pradel - Department of Pneumology

    Bron

    Michael DURUISSEAUX, MD, 0472357644 ext. +33, michael.duruisseaux@chu-lyon.fr

    Michael DURUISSEAUX, MD

    Not yet recruiting

  • University hospital of Grenoble Alpes - Department of dermatology

    Grenoble

    Julie CHARLES, MD, 0476767575 ext. +33, JCharles@chu-grenoble.fr

    Julie CHARLES, MD

    Not yet recruiting

  • University hospital of Grenoble Alpes - Department of Medical Oncology

    Grenoble

    Mathieu LARAMASSE, MD, mlaramas@chu-grenoble.fr

    Mathieu LARAMASSE, MD

    Not yet recruiting

  • Hôpital de la Croix Rousse - Department of Pneumology

    Lyon

    Lize KIAKOUAMA-MALEKA, MD, 0426109237 ext. +33, lize.kiakouama-maleka@chu-lyon.fr

    Lize KIAKOUAMA-MALEKA, MD

    Not yet recruiting

  • Hôpital Edouard Herriot - Department of urology

    Lyon

    Terminated

  • Centre Hospitalier Lyon Sud - Department of Medical Oncology

    Pierre-Bénite

    Denis MAILLET, MD, 0478864385 ext. +33, denis.maillet@chu-lyon.fr

    Denis MAILLET, MD

    Recruiting

  • Hôpital Lyon Sud - Department of Dermatology, HCL-Cancer Institute

    Pierre-Bénite

    Stéphane DALLE, MD, 0478861679, stephane.dalle@chu-lyon.fr

    Stéphane DALLE, MD

    Recruiting

  • Hôpital Lyon Sud - Department of pneumology,Thoracic oncology

    Pierre-Bénite

    Pierre Jean SOUQUET, MD, 0478864401 ext. +33, pierre-jean.souquet@chu-lyon.fr

    Pierre Jean SOUQUET, MD

    Recruiting

  • University hospital of Saint-Etienne - Department of dermatology

    Saint-Etienne

    Emmanuelle COUTY, MD, 0477828333 ext. +33, j.luc.perrot@chu-st-etienne.fr

    Emmanuelle COUTY, MD

    Not yet recruiting

Other trials in France

About this study

The ipilimumab and nivolumab combination is now part of the standard of care for the treatment of melanoma, renal and lung cancer patients. Grade 3/4 adverse events (AEs) occur in 30 to 60% of patients included in clinical trials. Grade 3/4 AEs are more frequently observed (50-60% of patients) in melanoma because ipilimumab is administrated at 3mg/kg in this population. Among these AEs, early detection of immune related AEs is critical to an adequate medical management. In this context, dedicated tools for remote monitoring of these patients are crucial.

The investigators developed within the Immucare consortium a simplified medical questionnaire which is addressed weekly to the patients. This questionnaire along with an algorithm gives to the clinician regular feedback on their patients' general symptoms. The investigators herein want to evaluate in a randomized prospective trial the efficacy of this remote monitoring to reduce the time between the start of AE and the reporting to the medical team, which could lead to detect and treat earlier AEs induced by nivolumab and ipilimumab in the melanoma, lung and renal cancer patients' population.

Being tested
Tele-monitoring
Keywords
Tele-monitoring, nivolumab, ipilimumab, immunotherapy
Medical subject headings
Melanoma, Lung Neoplasms, Kidney Neoplasms

What participants receive

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

  • Tele-monitoringBehavioural

    The tele-monitoring will consist in filling in a specific questionnaire once a week in the first 6 months, every 2 weeks until 12 months, and on-demand (in case of upcoming toxicity, at any time). These questionnaires will be reviewed by a coordinating nurse. According to the result of the questionnaire, the coordinating nurse will adapt patients' management, either by giving them a phone call, or inviting them to directly contact their medical department, or even plan an emergency hospitalization if necessary. The coordinating nurse will closely work with the investigator to adapt patients' management.

    Quality of life questionnaire (FACT-G) will also be filled in at inclusion, M3 and M12.

Study groups in NCT04605146
Study groupRoleWhat they receive
Tele-monitoring groupExperimentalIn the experimental group, in addition to routine practice, each patient will benefit of a tele-monitoring of one year, and a long term follow-up up to 5 years to evaluate the Overall Survival and the Progression-Free Survival. Quality of life questionnaire will also be filled in at inclusion, M3 and M12. 50 patients are expected in this arm.
Receives: Behavioral: Tele-monitoring
Control groupNo interventionIn the control group, patients will have a routine follow-up as per institutional practice, and a long term follow-up up to 5 years to evaluate the Overall Survival and the Progression-Free Survival. Quality of life questionnaire will also be filled in at inclusion, M3 and M12. 50 patients are expected in this arm.

What is being measured

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

  1. Delay between the start of a side effect and reporting to the medical team (average number of days per patient).

    The delay between the start of a side effect and medical information will be calculated for each AE and average per patient in each of the two groups studied, with its 95% confidence interval.The delays of the two groups will be compared using a Mann-Whitney test.

    Measured: 12 months

Secondary outcomes (9)

  1. Levels of morbidity based on CTC-AE v5 (all toxicities)

    Levels of morbidity based on CTC-AE v5 (all toxicities) will be compare using a generalised log linear regression. In case of several AEs, the average medical information per patient will be considered.

    Measured: 12 months

  2. Number of treatment interruptions and number of days of treatment delays interruptions, number of treatment discontinuation, number of dose reductions and and percentage of dose reduction

    Number of treatment interruptions and number of days of treatment delays interruptions, number of treatment discontinuation, number of dose reductions and and percentage of dose reduction will be compared in the two groups using a Mann-Whitney test

    Measured: 12 months

  3. Number of admissions in the emergency room

    Number of admissions in the emergency room will be compared in the two groups with a Wilcoxon rank sum test. The rate of admissions per patient-years will be calculated and compared between the 2 groups with a Negative Binomial generalized linear regression model accounting for overdispersed data and correlated events, using the log of follow-up time as an offset.

    Measured: 12 months

  4. Number of unplanned hospitalizations

    Number of unplanned hospitalizations will be compared in the two groups with a Wilcoxon rank sum test.

    The hospitalizations per patient-years will be calculated and compared between the 2 groups with a Negative Binomial generalized linear regression model accounting for overdispersed data and correlated events, using the log of follow-up time as an offset.

    Measured: 12 months

  5. Number of contact with general practitioner

    Number of contact with general practitioner will be compared in the two groups with a Wilcoxon rank sum test.

    Measured: 12 months

  6. benefit for clinicians: interview of clinicians on their opinion on the self-monitoring, evaluation to the impact on the consultations during the first year of treatment, assessed with satisfaction questionnaires

    benefit for clinicians will be compared in the 2 groups with adequate test according to the retained satisfaction scale

    Measured: Month 12

  7. Number of AE identified by clinicians

    Number of AE identified by clinicians will be compared in the two groups with a Wilcoxon rank sum test.

    In addition, the competitive risk of death with the recurrent events process will be explored using a joint frailty model (Rondeau V. et al. Joint frailty models for recurring events and death using maximum penalized likelihood estimation: application on cancer events. Biostatistics (2007), 8, 4, pp. 708-721).

    Measured: 12 months

  8. Overall quality of Life assessed with standardized QoL questionnaires (FACT-G)

    Overall quality of Life will be described and compared between the two groups with the Student t-test, or the Wilcoxon rank-sum test in case of non-normality of the distributions. All data recorded at the follow-up visits will be considered, whatever the actual date of the visit

    Measured: 12 months

  9. Adherence: The number of full symptoms report completions and adherence to the completion schedule

    Adherence will be described in the experimental group. All data recorded at the follow-up visits will be considered, whatever the actual date of the visit.

    Measured: 12 months

Timeline

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

  1. First posted27 Oct 2020
  2. Study start5 May 2021
  3. Primary completion5 Nov 2028 (estimated)
  4. Study completion5 Nov 2028 (estimated)

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 N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04605146
Sponsor's protocol ID
69HCL20_0492
Other IDs
2020-A02372-37
Acronym
MONITOR
Status last verified
Oct 2024
First submitted
16 Oct 2020
Last updated
16 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Tele-monitoring in people with Melanoma and Lung Cancer, run by Hospices Civils de Lyon at 10 sites in France.

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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Stéphane DALLE (0478861679 ext. +33, stephane.dalle@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Delay between the start of a side effect and reporting to the medical team (average number of days per patient). (time frame: 12 months). 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 NCT04605146.

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 16 Oct 2024.

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