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NCT04860076
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
trial testing Pembrolizumab in Melanoma in 400 participants. Status unknown.
6 June 2022
Quick facts
| Lead sponsor | Asylia Diagnostics BV |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 400 |
| Start date | 6 June 2020 |
| Primary completion | 6 June 2022 |
| Estimated completion | 6 June 2023 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Pembrolizumab (pembrolizumab) — full drug profile →
Conditions studied
- Melanoma — all drugs for Melanoma →
- Lung Cancer — all drugs for Lung Cancer →
Sponsor
Asylia Diagnostics BV
Who can join
Adults 18 to 95, any sex, with Melanoma or Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04860076
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Melanoma
Currently open trials in the same condition.
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- NCT07224425 — A Study in People With Advanced Cancer (Solid Tumours) to Test Different Doses of BI 3810944 and to Find Out Whether it · Phase 1 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04860076 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Asylia Diagnostics BV
- Last refreshed: 26 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04860076.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing