TriaL to investigAte imMune checkpoint inhibitor related siccA syndrome

• Conditions: speekselproductie; dry eyes and/or dry mouth; 10030064

• Registration Number: NL-OMON56760
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• Treatment with first-line monotherapy anti-PD(L)1 or combination therapy with
anti-PD(L)1 and anti-CTLA4 for the treatment of e.g. melanoma, renal cell,
esophagus, and urothelial cell cancer.
• ICI can be administered in the metastatic, inoperable or (neo)adjuvant
setting in accordance with the current standard of care.

Exclusion Criteria

Exclusion criteria are the following:
• Combination therapy with chemotherapy, targeted therapy or tyrosine kinase
inhibitors
• Previous treatment with ICI, including anti-PD(L)1 and anti-CTLA4
• Concurrent treatment with the following medication: anticholinergic
medications, alpha receptor antagonist, antipsychotics, and antihistamines
• History of systemic autoimmune disease (rheumatoid arthritis, Sjögren*s
disease, systemic sclerosis, inflammatory myopathies and sarcoidosis)
• History of salivary gland irradiation

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main objective of this study is to examine the incidence and severity of<br /><br>sicca symptoms after ICI administration at 3 and 6 months. Depending on the<br /><br>results of this study, we will consider to perform a future study to evaluate<br /><br>the effect of early administration of low dose steroids to treat symptoms of<br /><br>the sicca syndrome.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objective(s):<br /><br>The secondary objectives are:<br /><br>1) to measure changes in objective measures of oral and ocular dryness after<br /><br>ICI administration;<br /><br>2) to investigate whether IFN signatures are a predictive marker of sicca<br /><br>syndrome.<br /><br><br /><br>Exploratory objective<br /><br>To evaluate the efficacy of early administration of low dose steroids for<br /><br>patients with reported sicca. </p><br>