CClinicalTrials.gg
Status unknownNCT04860076Updated Apr 26, 2021

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

An observational study in Melanoma and Lung Cancer, sponsored by Asylia Diagnostics BV. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2021-04-26.

Sponsored by Asylia Diagnostics BV · Observational

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
400
Ages
18 Years to 95 Years
Sex
All
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Study 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.

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Conditions studied

  • Melanoma
  • Lung Cancer

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In context

Melanoma

3,005 studies on the registry are indexed under Melanoma; 519 are open to participants now.

This study's planned enrollment of 400 is above the median of 182 across 438 observational studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

This is the only study on the registry with Asylia Diagnostics BV as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects treated by immune checkpoint inhibitors

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
400 participants (estimated)
Patient registry
No

Interventions

  • DrugPembrolizumab

    Standard of care

    Also known as: Ipilimumab, Nivolumab

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What researchers measure

Primary outcomes

  1. RECIST

    Response Evaluation Criteria in Solid Tumours

    Time frame: 24 weeks

Secondary outcomes

  1. PFS

    Progression free survival

    Time frame: 24 weeks

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Study locations

1 of 1 sites recruiting
  • Universitair Ziekenhuis Antwerpen
    Edegem, 2650, Belgium
    Recruiting
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References and documents

Publications

  • 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. PubMed 30657859 ↗
  • 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. PubMed 31173063 ↗
  • 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. PubMed 30361681 ↗
  • 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. PubMed 27367787 ↗
  • 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. PubMed 30053725 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04860076
Lead sponsor
Asylia Diagnostics BV
Responsible party
Sponsor
First posted
Apr 26, 2021
Start date
Jun 6, 2020
Primary completion
Jun 6, 2022 (estimated)
Completion
Jun 6, 2023 (estimated)
Last update
Apr 26, 2021

Study contacts

Andrey Khmelevskiy, MSc
Contact
andrey.khmelevskiy@asyliadx.com
+32 492 40 40 24

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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