Status:
UNKNOWN
Open-label, Uncontrolled, Non-Interventional, Retrospective Study to Evaluate Molecular Determinants of Outcome to the Immune Checkpoint Inhibitors (Anti-PD-1/Anti-PD-L1 Monoclonal Antibodies) Treatment for Solid Tumors
Lead Sponsor:
Asylia Diagnostics BV
Conditions:
Melanoma
Lung Cancer
Eligibility:
All Genders
18-95 years
Brief Summary
The recent approval of ICB treatments targeting cytotoxic T-lymphocyte antigen 4 (CTLA-4) and programmed cell death-1 (PD-1/PD-L1) by the US Food and Drug Administration has offered an improved treatm...
Eligibility Criteria
Inclusion
- Females and males 18-95 y.o.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Karnofsky \>/=70%)
- Histologically or cytologically confirmed melanoma or lung cancer, the grade of the tumor, diagnosed before enrolment into the study.
- Treatment with anti-PD1/anti-PD-L1 drugs and anti-PD1/anti-PD-L1 drugs in combinations with other therapies
- Subjects may have received any number of prior lines of chemotherapy or targeted therapies
- Availability of FFPE tissue samples received prior to any type of antitumor treatment start
- Complete medical records (stage, receptors status, demographic data)
Exclusion
- Has had chemotherapy, targeted small molecule therapy, or radiation therapy \>30 Gray within 14 days prior to the baseline biopsy or persistent adverse events (AE) related to prior therapy, which have not recovered (i.e., AEs should be ≤Grade 1 or ≤the value collected at baseline) from AEs due to a previously administered intervention
- Any evidence of uncontrolled system pathology, active infections, active bleeding diathesis, renal graft, hepatitis B, C or HIV.
- Autoimmune diseases such as Addison's disease, thyroiditis, lupus (SLE), Sjogren's syndrome, scleroderma, myasthenia gravis, Grave's disease, and Goodpasture's syndrome, requiring active therapy with corticosteroids. If a patient has been taking steroids, at least 2 weeks must have passed since the last dose. Patients with a history of endocrinopathies (e.g. hypothyroidism, adrenal insufficiency, hypopituitarism) are eligible if they are stable on hormone replacement therapy.
- Patients with prior splenectomy, ocular melanoma
- Recent (within 1 year) history of another cancer with the exceptions of non-melanoma skin cancer, superficial bladder cancer, or localized cervical cancer
- Pregnant patients
Key Trial Info
Start Date :
June 6 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 6 2023
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04860076
Start Date
June 6 2020
End Date
June 6 2023
Last Update
April 26 2021
Active Locations (1)
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1
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650