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

NCT04860076 | Unknown FDA Drug

• 1 other identifier: BR00012020
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Melanoma; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• RECIST

  Response Evaluation Criteria in Solid Tumours

  24 weeks

Secondary Outcomes (1)

• PFS

  24 weeks

Interventions

Pembrolizumab DRUG

Standard of care

Also known as: Ipilimumab, Nivolumab

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects treated by immune checkpoint inhibitors

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Asylia Diagnostics BV: lead

Study Sites (1)

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

RECRUITING

Related 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.

  PMID: 30657859 BACKGROUND

• 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. No abstract available.

  PMID: 31173063 BACKGROUND

• Champiat S, Ferrara R, Massard C, Besse B, Marabelle A, Soria JC, Ferte 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.

  PMID: 30361681 BACKGROUND

• 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.

  PMID: 27367787 BACKGROUND

• Fuentes-Antras J, Provencio M, Diaz-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.

  PMID: 30053725 BACKGROUND

MeSH Terms

Conditions

Melanoma; Lung Neoplasms

Interventions

pembrolizumab; Ipilimumab; Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Andrey Khmelevskiy, MSc

CONTACT

+32 492 40 40 24; andrey.khmelevskiy@asyliadx.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 26, 2021
• Study Start: June 6, 2020
• Primary Completion: June 6, 2022
• Study Completion: June 6, 2023
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)