PRURICHECKPOIN: Pruritus and Melanoma and Cutaneous Carcinomas Treated With Immunotherapy

Sponsor

University Hospital, Brest (Other)

Overall Status

Completed

CT.gov ID

NCT04365244

Collaborator

(none)

181

Enrollment

Locations

3.1

Actual Duration (Months)

90.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pruritus

Study Design

Study Type:

Observational

Actual Enrollment :

181 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Pruritus and Melanoma and Cutaneous Carcinomas Treated With Immunotherapy (PRURICHECKPOINT)

Actual Study Start Date :

Aug 19, 2019

Actual Primary Completion Date :

Nov 22, 2019

Actual Study Completion Date :

Nov 22, 2019

Outcome Measures

Primary Outcome Measures

putative causes of pruritus [through study completion, an average of 1 year]
questionnaire

Secondary Outcome Measures

presence of other side effects [through study completion, an average of 1 year]
questionnaire
survival [through study completion, an average of 1 year]
questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU de Brest	Brest		France	29609
2	CH de Landerneau	Landerneau		France

Sponsors and Collaborators

University Hospital, Brest

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Brest

ClinicalTrials.gov Identifier:

NCT04365244

Other Study ID Numbers:

PRURICHECKPOIN

First Posted:

Apr 28, 2020

Last Update Posted:

Apr 28, 2020

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pruritus

Study Results

No Results Posted as of Apr 28, 2020