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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04860076
• Other study ID #: BR00012020
• Status: Recruiting
• Start date: June 6, 2020
• Est. completion date: June 6, 2023

Study information

• Verified date: April 2021
• Source: Asylia Diagnostics BV
• Contact: Andrey Khmelevskiy, MSc
• Phone: +32 492 40 40 24
• Email: andrey.khmelevskiy[@]asyliadx.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 treatment chance for a variety of malignant tumors, including those with a particularly poor prognosis. However, a growing number of studies and case reports show that immunotherapy may accelerate tumor progression in a significant subset of patients ranging from 9% to 27% across multiple histologies and lead to so-called hyperprogressive disease (HPD) that leads to a rapid patient death.

During this NIS study, Asylia Diagnostics aims to fill in the first layer of knowledge leading to the identification of predictive biomarkers and biological mechanisms that could be used for the prediction, diagnosis, and treatment of melanoma and NSCLC HPD patients.

The study is a retrospective clinical study. During this study basic historical medical information and scrolls from FFPE-preserved biopsies taken prior to immunotherapy treatment will be collected. The nature of the study is not invasive and non interruptive to the standard of care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 6, 2023
• Est. primary completion date: June 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Lung Cancer
• Melanoma

Intervention

Drug:
• Pembrolizumab
Standard of care

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Edegem

Sponsors (1)

Lead Sponsor	Collaborator
Asylia Diagnostics BV

Country where clinical trial is conducted

Belgium, 

References & Publications (5)

Borcoman E, Kanjanapan Y, Champiat S, Kato S, Servois V, Kurzrock R, Goel S, Bedard P, Le Tourneau C. Novel patterns of response under immunotherapy. Ann Oncol. 2019 Mar 1;30(3):385-396. doi: 10.1093/annonc/mdz003. — View Citation

Champiat S, Besse B, Marabelle A. Hyperprogression during immunotherapy: do we really want to know? Ann Oncol. 2019 Jul 1;30(7):1028-1031. doi: 10.1093/annonc/mdz184. — View Citation

Champiat S, Ferrara R, Massard C, Besse B, Marabelle A, Soria JC, Ferté C. Hyperprogressive disease: recognizing a novel pattern to improve patient management. Nat Rev Clin Oncol. 2018 Dec;15(12):748-762. doi: 10.1038/s41571-018-0111-2. Review. — View Citation

Friedman CF, Proverbs-Singh TA, Postow MA. Treatment of the Immune-Related Adverse Effects of Immune Checkpoint Inhibitors: A Review. JAMA Oncol. 2016 Oct 1;2(10):1346-1353. doi: 10.1001/jamaoncol.2016.1051. Review. — View Citation

Fuentes-Antrás J, Provencio M, Díaz-Rubio E. Hyperprogression as a distinct outcome after immunotherapy. Cancer Treat Rev. 2018 Nov;70:16-21. doi: 10.1016/j.ctrv.2018.07.006. Epub 2018 Jul 18. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RECIST	Response Evaluation Criteria in Solid Tumours	24 weeks
Secondary	PFS	Progression free survival	24 weeks