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NCT Number: NCT04605146

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

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.

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Key information

Conditions

Melanoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Renal Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupement hospitalier Est - Multidisciplinary oncological platform, Bron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Tele-monitoring

Behavioral

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.

Primary outcomes

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

    Time frame: 12 months

    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.

Secondary outcomes

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

    Time frame: 12 months

    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.

  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

    Time frame: 12 months

    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

  3. Number of admissions in the emergency room

    Time frame: 12 months

    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.

  4. Number of unplanned hospitalizations

    Time frame: 12 months

    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.

  5. Number of contact with general practitioner

    Time frame: 12 months

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

  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

    Time frame: Month 12

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

  7. Number of AE identified by clinicians

    Time frame: 12 months

    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).

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

    Time frame: 12 months

    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

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

    Time frame: 12 months

    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.

Other outcomes

  1. Overall Survival and Progression Free Survival assessed at 1 year after inclusion

    Time frame: At 1 year after inclusion

    Overall Survival and Progression Free Survival will be estimated based on computed time between randomisation and date of the first event which ever would it be (death or progression) or date of last follow-up. Survival probabilities will be estimated suing Kaplan Meier approach

  2. Overall Survival and Progression Free Survival assessed at 2 years after inclusion

    Time frame: At 2 years after inclusion

    Overall Survival and Progression Free Survival will be estimated based on computed time between randomisation and date of the first event which ever would it be (death or progression) or date of last follow-up. Survival probabilities will be estimated suing Kaplan Meier approach

  3. Overall Survival and Progression Free Survival assessed at 5 years after inclusion

    Time frame: At 5 years after inclusion

    Overall Survival and Progression Free Survival will be estimated based on computed time between randomisation and date of the first event which ever would it be (death or progression) or date of last follow-up. Survival probabilities will be estimated suing Kaplan Meier approach

Study contacts

Contact information is provided by the study sponsor or research team.

Aurélie RABIER

CONTACT

[email protected]

0478861679 ext. +33

Stéphane DALLE

CONTACT

[email protected]

0478861679 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: MONITOR

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Oct 27, 2020
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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