Pruritus and Melanoma and Cutaneous Carcinomas Treated With Immunotherapy

Completed

• Conditions: Pruritus

• Registration Number: NCT04365244
• Lead Sponsor: University Hospital, Brest

Brief Summary

Immune checkpoint inhibitors (ICIs) are commonly used in the therapeutic arsenal of metastatic melanoma, Merkel cell carcinoma and cutaneous squamous cell carcinoma, thanks to their inhibiting effects on cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA4) and anti-programmed death-1 (anti-PD1) respectively. These treatments can induce numerous cutaneous and non-cutaneous adverse effects that are mainly due to their immunological action. Their most frequent adverse effects are dysthyroidism, autoimmune hepatitis, colitis and skin disorders. Among those, pruritus is frequently reported as a side effect of these treatments. Its incidence has been estimated between 11% and 47%. Pruritus can deeply affect the patient's quality of life and may lead to treatment discontinuation. Until now, ICI-related pruritus has been poorly studied and it is not understood. In the literature, data on the presence and characteristics of pruritus in patients treated by ICIs were provided, without analyzing the causes of this pruritus. Indeed, it is not known if the occurrence of pruritus is related to direct or indirect effects of ICIs. Some authors reported a correlation between the occurrence of cutaneous adverse events under ICIs and the survival. The principal aim of our study was to analyze the putative causes of pruritus occurring in patients treated with ICIs for melanomas and cutaneous carcinomas. The other objectives were to assess the association between the occurrence of pruritus and survival, and between the other adverse events and pruritus.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-04
• Study Start: 2019-08-19
• Primary Completion: 2019-11-22
• Study Completion: 2019-11-22
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-27
• Last Update Submitted: 2020-04-27
• Study First Posted: 2020-04-28
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

Inclusion Criteria

• age 18 years and older,
• treated with ICIs (nivolumab, pembrolizumab, ipilimumab, cemiplimab) for melanoma, squamous cell carcinoma or Merkel cell carcinoma
• not having formulated any opposition

Exclusion Criteria

• age under 18 years,
• adults not legally competent,
• presence of pruritus at the inclusion,
• participation refusal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
putative causes of pruritus	through study completion, an average of 1 year	questionnaire

Secondary Outcome Measures

Name	Time	Method
presence of other side effects	through study completion, an average of 1 year	questionnaire
survival	through study completion, an average of 1 year	questionnaire

Trial Locations

Locations (2)

CH de Landerneau; 🇫🇷 Landerneau, France

CHRU de Brest; 🇫🇷 Brest, France