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NCT04631731: ICEMELT
Risk Factors of Immune-ChEckpoint Inhibitors MEdiated Liver, Gastrointestinal, Endocrine and Skin Toxicity
Phase 1, PHASE2 trial testing Blood screening in Lung Cancer, Nonsmall Cell in 200 participants. Status unknown.
10 December 2024
Quick facts
| Lead sponsor | Western Sydney Local Health District |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 200 |
| Start date | 15 December 2020 |
| Primary completion | 10 December 2024 |
| Estimated completion | 10 December 2025 |
| Sites | 2 locations across Australia |
Drugs / interventions tested
- Blood screening
- Tissue screening
Conditions studied
- Lung Cancer, Nonsmall Cell — all drugs for Lung Cancer, Nonsmall Cell →
- Renal Cell Carcinoma — all drugs for Renal Cell Carcinoma →
- Melanoma — all drugs for Melanoma →
- Gastric Cancer — all drugs for Gastric Cancer →
Sponsor
Western Sydney Local Health District — full company profile →
Who can join
Eligibility, any sex, with Lung Cancer, Nonsmall Cell or Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
"Risk factors of Immune-ChEckpoint inhibitor MEdiated Liver, gastrointestinal, endocrine and skin Toxicity" (ICEMELT) study is a prospective multicenter cohort study, enrolling patients who are scheduled to receive (1) single agent PD1/L1 inhibitor; (2) PD1/L1 inhibitor plus CTLA4 inhibitor; (3) platinum-based chemotherapy + PD1/L1 inhibitor; (4) PD1/L1 inhibitor and tyrosine kinase inhibitor and (5) PD1/L1 inhibitor and vascular endothelial growth factor (VEGF) inhibitor.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Current Applications of Liquid Biopsy in Gastrointestinal Cancer Disease-From Early Cancer Detection to Individualized Cancer Treatment.
David P, Mittelstädt A, Kouhestani D, Anthuber A, et al · · 2023 · cited 10× · PMID 37046585 · DOI 10.3390/cancers15071924 -
Identification and Characterisation of Infiltrating Immune Cells in Malignant Pleural Mesothelioma Using Spatial Transcriptomics.
Shek D, Gloss B, Lai J, Ma L, et al · · 2023 · cited 9× · PMID 37104017 · DOI 10.3390/mps6020035 -
Emerging advances in drug delivery systems (DDSs) for optimizing cancer complications.
Li K, Guo B, Gu J, Ta N, et al · · 2025 · cited 8× · PMID 39759851 · DOI 10.1016/j.mtbio.2024.101375 -
In-depth profiling of tumor tissue derived from malignant pleural mesothelioma patients identifies potential biomarkers predicting response to immune-checkpoint inhibitor therapy.
Shek D, Gao B, Mahajan H, Nagrial A, et al · · 2024 · cited 2× · PMID 39104419 · DOI 10.1016/j.gendis.2023.101189 -
Cell-cell interactions as predictive and prognostic markers for drug responses in cancer.
Lu X, Tan X, Kim EJ, Jin X, et al · · 2025 · cited 1× · PMID 41063141 · DOI 10.1186/s13073-025-01518-5
Verify or expand the search:
- PubMed search for NCT04631731
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Western Sydney Local Health District trials
Trials by the same sponsor.
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- NCT06365411 — GEnomic Medicine in Kidney Transplantation Study · not yet recruiting
- NCT06828562 — GENomic Predictors in A Multi-Ethnic Population With Kidney Disease Study · enrolling by invitation
- NCT05509153 — A Randomised Controlled Trial, Of N-Acetyl Cysteine (NAC), for Premanifest Huntingtin Gene Expansion Carriers · Phase 2 · recruiting
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 NCT04631731 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Western Sydney Local Health District
- Last refreshed: 1 June 2023
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/NCT04631731.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing