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

NCT04605146 | Recruiting

• 2 other identifiers: 69HCL20_04922020-A02372-37
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 10

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.

Conditions

Melanoma; Lung Cancer; Renal Cancer

Keywords

Tele-monitoring; nivolumab; ipilimumab; immunotherapy

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (9)

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

  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

  12 months

• Number of admissions in the emergency room

  12 months

• Number of unplanned hospitalizations

  12 months

• Number of contact with general practitioner

  12 months

Other Outcomes (3)

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

  At 1 year after inclusion

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

  At 2 years after inclusion

• Overall Survival and Progression Free Survival assessed at 5 years after inclusion

  At 5 years after inclusion

Study Arms (2)

Tele-monitoring group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

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.

Tele-monitoring group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (10)

Groupement hospitalier Est - Multidisciplinary oncological platform

Bron, France

NOT YET RECRUITING

Hôpital Louis Pradel - Department of Pneumology

Bron, France

NOT YET RECRUITING

University hospital of Grenoble Alpes - Department of dermatology

Grenoble, France

NOT YET RECRUITING

University hospital of Grenoble Alpes - Department of Medical Oncology

Grenoble, France

NOT YET RECRUITING

Hôpital de la Croix Rousse - Department of Pneumology

Lyon, France

NOT YET RECRUITING

Hôpital Edouard Herriot - Department of urology

Lyon, France

TERMINATED

Centre Hospitalier Lyon Sud - Department of Medical Oncology

Pierre-Bénite, France

RECRUITING

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

Pierre-Bénite, France

RECRUITING

Hôpital Lyon Sud - Department of pneumology,Thoracic oncology

Pierre-Bénite, France

RECRUITING

University hospital of Saint-Etienne - Department of dermatology

Saint-Etienne, France

NOT YET RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Melanoma; Lung Neoplasms; Kidney Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Stéphane DALLE

  Department of Dermatology, HCL-Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphane DALLE

CONTACT

0478861679; stephane.dalle@chu-lyon.fr

Aurélie RABIER

CONTACT

0478861679; aurelie.rabier@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 27, 2020
• Study Start: May 5, 2021
• Primary Completion (Estimated): November 5, 2028
• Study Completion (Estimated): November 5, 2028
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)