NL-OMON56760
Not yet recruiting
Not Applicable
TriaL to investigAte imMune checkpoint inhibitor related siccA syndrome - LAMA trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- speekselproductie
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 100
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
Not specified
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