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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 (MONITOR)

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ClinicalTrials.gov Identifier: NCT04605146
Recruitment Status : Recruiting
First Posted : October 27, 2020
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Melanoma Lung Cancer Renal Cancer Behavioral: Tele-monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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.
Actual Study Start Date : May 5, 2021
Estimated Primary Completion Date : May 1, 2028
Estimated Study Completion Date : May 1, 2028


Arm Intervention/treatment
Experimental: Tele-monitoring group

In 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.

Behavioral: Tele-monitoring

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.


No Intervention: Control group

In 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04605146


Contacts
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Contact: Stéphane DALLE 0478861679 ext +33 stephane.dalle@chu-lyon.fr
Contact: Aurélie RABIER 0478861679 ext +33 aurelie.rabier@chu-lyon.fr

Locations
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France
Groupement hospitalier Est - Multidisciplinary oncological platform Not yet recruiting
Bron, France
Contact: Christophe SAJOUS, MD    0427856577 ext +33    christophe.sajous@chu-lyon.fr   
Principal Investigator: Christophe SAJOUS, MD         
Hôpital Louis Pradel - Department of Pneumology Not yet recruiting
Bron, France
Contact: Michael DURUISSEAUX, MD    0472357644 ext +33    michael.duruisseaux@chu-lyon.fr   
Principal Investigator: Michael DURUISSEAUX, MD         
University hospital of Grenoble Alpes - Department of dermatology Not yet recruiting
Grenoble, France
Contact: Julie CHARLES, MD    0476767575 ext +33    JCharles@chu-grenoble.fr   
Principal Investigator: Julie CHARLES, MD         
University hospital of Grenoble Alpes - Department of Medical Oncology Not yet recruiting
Grenoble, France
Contact: Mathieu LARAMASSE, MD       mlaramas@chu-grenoble.fr   
Principal Investigator: Mathieu LARAMASSE, MD         
Hôpital de la Croix Rousse - Department of Pneumology Not yet recruiting
Lyon, France
Contact: Lize KIAKOUAMA-MALEKA, MD    0426109237 ext +33    lize.kiakouama-maleka@chu-lyon.fr   
Principal Investigator: Lize KIAKOUAMA-MALEKA, MD         
Hôpital Edouard Herriot - Department of urology Terminated
Lyon, France
Centre Hospitalier Lyon Sud - Department of Medical Oncology Recruiting
Pierre-Bénite, France
Contact: Denis MAILLET, MD    0478864385 ext +33    denis.maillet@chu-lyon.fr   
Principal Investigator: Denis MAILLET, MD         
Sub-Investigator: Julien PERON, MD         
Sub-Investigator: Benoit YOU, MD         
Sub-Investigator: Gilles FREYER, MD         
Sub-Investigator: Véronique TRILLET-LENOIR, MD         
Sub-Investigator: Nathalie BONNIN, MD         
Sub-Investigator: Sophie TARTAS, MD         
Sub-Investigator: Amandine BRUYAS, MD         
Sub-Investigator: Sophie DUPLOMB, MD         
Sub-Investigator: Christophe SAJOUS, MD         
Hôpital Lyon Sud - Department of Dermatology, HCL-Cancer Institute Recruiting
Pierre-Bénite, France
Contact: Stéphane DALLE, MD    0478861679    stephane.dalle@chu-lyon.fr   
Principal Investigator: Stéphane DALLE, MD         
Hôpital Lyon Sud - Department of pneumology,Thoracic oncology Recruiting
Pierre-Bénite, France
Contact: Pierre Jean SOUQUET, MD    0478864401 ext +33    pierre-jean.souquet@chu-lyon.fr   
Principal Investigator: Pierre Jean SOUQUET, MD         
Sub-Investigator: Sébastien COURAUD, MD         
Sub-Investigator: Nathalie FREYMOND, MD         
Sub-Investigator: Clara FONTAINE-DELARUELLE, MD         
University hospital of Saint-Etienne - Department of dermatology Not yet recruiting
Saint-Étienne, France
Contact: Emmanuelle COUTY, MD    0477828333 ext +33    j.luc.perrot@chu-st-etienne.fr   
Principal Investigator: Emmanuelle COUTY, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Stéphane DALLE Department of Dermatology, HCL-Cancer Institute
Additional Information:
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04605146    
Other Study ID Numbers: 69HCL20_0492
2020-A02372-37 ( Other Identifier: ID-RCB )
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Tele-monitoring
nivolumab
ipilimumab
immunotherapy
Additional relevant MeSH terms:
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Melanoma
Kidney Neoplasms
Carcinoma, Renal Cell
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial