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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)

Primary Purpose

Melanoma, Lung Cancer, Renal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Tele-monitoring
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Melanoma focused on measuring Tele-monitoring, nivolumab, ipilimumab, immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Groupement hospitalier Est - Multidisciplinary oncological platform
  • Hôpital Louis Pradel - Department of Pneumology
  • University hospital of Grenoble Alpes - Department of dermatology
  • University hospital of Grenoble Alpes - Department of Medical Oncology
  • Hôpital de la Croix Rousse - Department of Pneumology
  • Hôpital Edouard Herriot - Department of urology
  • Centre Hospitalier Lyon Sud - Department of Medical OncologyRecruiting
  • Hôpital Lyon Sud - Department of Dermatology, HCL-Cancer InstituteRecruiting
  • Hôpital Lyon Sud - Department of pneumology,Thoracic oncologyRecruiting
  • University hospital of Saint-Etienne - Department of dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tele-monitoring group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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.
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.
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.
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
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).
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
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.

Full Information

First Posted
October 16, 2020
Last Updated
July 26, 2021
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT04605146
Brief 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
Acronym
MONITOR
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
May 1, 2028 (Anticipated)
Study Completion Date
May 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Lung Cancer, Renal Cancer
Keywords
Tele-monitoring, nivolumab, ipilimumab, immunotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tele-monitoring group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tele-monitoring
Intervention Description
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 Outcome Measure Information:
Title
Delay between the start of a side effect and reporting to the medical team (average number of days per patient).
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Levels of morbidity based on CTC-AE v5 (all toxicities)
Description
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.
Time Frame
12 months
Title
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
Description
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
Time Frame
12 months
Title
Number of admissions in the emergency room
Description
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.
Time Frame
12 months
Title
Number of unplanned hospitalizations
Description
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.
Time Frame
12 months
Title
Number of contact with general practitioner
Description
Number of contact with general practitioner will be compared in the two groups with a Wilcoxon rank sum test.
Time Frame
12 months
Title
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
Description
benefit for clinicians will be compared in the 2 groups with adequate test according to the retained satisfaction scale
Time Frame
Month 12
Title
Number of AE identified by clinicians
Description
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).
Time Frame
12 months
Title
Overall quality of Life assessed with standardized QoL questionnaires (FACT-G)
Description
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
Time Frame
12 months
Title
Adherence: The number of full symptoms report completions and adherence to the completion schedule
Description
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.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Overall Survival and Progression Free Survival assessed at 1 year after inclusion
Description
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
Time Frame
At 1 year after inclusion
Title
Overall Survival and Progression Free Survival assessed at 2 years after inclusion
Description
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
Time Frame
At 2 years after inclusion
Title
Overall Survival and Progression Free Survival assessed at 5 years after inclusion
Description
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
Time Frame
At 5 years after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane DALLE
Phone
0478861679
Ext
+33
Email
stephane.dalle@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélie RABIER
Phone
0478861679
Ext
+33
Email
aurelie.rabier@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane DALLE
Organizational Affiliation
Department of Dermatology, HCL-Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupement hospitalier Est - Multidisciplinary oncological platform
City
Bron
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe SAJOUS, MD
Phone
0427856577
Ext
+33
Email
christophe.sajous@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Christophe SAJOUS, MD
Facility Name
Hôpital Louis Pradel - Department of Pneumology
City
Bron
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael DURUISSEAUX, MD
Phone
0472357644
Ext
+33
Email
michael.duruisseaux@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Michael DURUISSEAUX, MD
Facility Name
University hospital of Grenoble Alpes - Department of dermatology
City
Grenoble
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie CHARLES, MD
Phone
0476767575
Ext
+33
Email
JCharles@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Julie CHARLES, MD
Facility Name
University hospital of Grenoble Alpes - Department of Medical Oncology
City
Grenoble
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu LARAMASSE, MD
Email
mlaramas@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Mathieu LARAMASSE, MD
Facility Name
Hôpital de la Croix Rousse - Department of Pneumology
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lize KIAKOUAMA-MALEKA, MD
Phone
0426109237
Ext
+33
Email
lize.kiakouama-maleka@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Lize KIAKOUAMA-MALEKA, MD
Facility Name
Hôpital Edouard Herriot - Department of urology
City
Lyon
Country
France
Individual Site Status
Terminated
Facility Name
Centre Hospitalier Lyon Sud - Department of Medical Oncology
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis MAILLET, MD
Phone
0478864385
Ext
+33
Email
denis.maillet@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Denis MAILLET, MD
First Name & Middle Initial & Last Name & Degree
Julien PERON, MD
First Name & Middle Initial & Last Name & Degree
Benoit YOU, MD
First Name & Middle Initial & Last Name & Degree
Gilles FREYER, MD
First Name & Middle Initial & Last Name & Degree
Véronique TRILLET-LENOIR, MD
First Name & Middle Initial & Last Name & Degree
Nathalie BONNIN, MD
First Name & Middle Initial & Last Name & Degree
Sophie TARTAS, MD
First Name & Middle Initial & Last Name & Degree
Amandine BRUYAS, MD
First Name & Middle Initial & Last Name & Degree
Sophie DUPLOMB, MD
First Name & Middle Initial & Last Name & Degree
Christophe SAJOUS, MD
Facility Name
Hôpital Lyon Sud - Department of Dermatology, HCL-Cancer Institute
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane DALLE, MD
Phone
0478861679
Email
stephane.dalle@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Stéphane DALLE, MD
Facility Name
Hôpital Lyon Sud - Department of pneumology,Thoracic oncology
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Jean SOUQUET, MD
Phone
0478864401
Ext
+33
Email
pierre-jean.souquet@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Pierre Jean SOUQUET, MD
First Name & Middle Initial & Last Name & Degree
Sébastien COURAUD, MD
First Name & Middle Initial & Last Name & Degree
Nathalie FREYMOND, MD
First Name & Middle Initial & Last Name & Degree
Clara FONTAINE-DELARUELLE, MD
Facility Name
University hospital of Saint-Etienne - Department of dermatology
City
Saint-Étienne
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle COUTY, MD
Phone
0477828333
Ext
+33
Email
j.luc.perrot@chu-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Emmanuelle COUTY, MD

12. IPD Sharing Statement

Links:
URL
https://www.chu-lyon.fr/fr/cancer-immucare
Description
Related Info

Learn more about this trial

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

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