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NCT04658303
Evolution of Metabolic and Immune Dysfunction in In-transit Melanoma
trial testing Pimonidazole in Melanoma in 20 participants. Currently enrolling.
31 March 2028
Quick facts
| Lead sponsor | Yana Najjar |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 24 February 2021 |
| Primary completion | 31 March 2028 |
| Estimated completion | 31 March 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Pimonidazole — full drug profile →
Conditions studied
- Melanoma — all drugs for Melanoma →
Sponsor
Yana Najjar — full company profile →
Who can join
18 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Melanoma in-transit metastases (ITMs) continue to represent a therapeutic dilemma, in that no standard method of treatment has been uniformly adopted. The complexity and heterogeneity of patient and disease characteristics, including the location and number of ITMs presents a barrier to a one size fits all treatment approach. Treatment of patients with limited regional disease remains challenging. Patients are typically treated with a combination of surgery, regional therapy, systemic therapy. Data on the management of ITMs is limited, even with the availability of immunotherapy (IMT). This study will use the unique etiology of ITMs to facilitate the understanding of how individual lesions metabolically and immunologically evolve as they move away from the primary tumor site. It is hypothesize that as ITMs move away from the primary melanoma site each will harbor progressively hypermetabolic tumor cells and a harsher microenvironment.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Single-cell RNA sequencing: enhancing the predictive accuracy of tumor immunotherapy efficacy.
Zhou W, Huang Z, Wu Z, Tang M, et al · · 2025 · cited 3× · PMID 40857744 · DOI 10.1042/ebc20253017 -
Immune profiling in oncology: bridging the gap between technology and treatment.
Ravi N, Tye GJ, Dhaliwal SS, Musa MY, et al · · 2025 · cited 3× · PMID 40856894 · DOI 10.1007/s12032-025-03002-x
Verify or expand the search:
- PubMed search for NCT04658303
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Pimonidazole
Trials testing the same drug.
- NCT06831071 — Evaluation of Hypoxia in Primary Melanoma · recruiting
- NCT03718650 — Total Tumor Mapping (TTM) for Resectable Pancreatic Cancer · EARLY_PHASE1 · withdrawn
Other recruiting trials for Melanoma
Currently open trials in the same condition.
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Other Yana Najjar trials
Trials by the same sponsor.
- NCT06831071 — Evaluation of Hypoxia in Primary Melanoma · recruiting
- NCT06216938 — RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis · EARLY_PHASE1 · recruiting
- NCT04572451 — Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanom · Phase 1 · recruiting
- NCT04493203 — Nivolumab Plus Axitinib in Patients With Anti-PD1 Refractory Advanced Melanoma · Phase 2 · completed
- NCT02818023 — Dose-seeking Study of Pembrolizumab Plus Vemurafenib and Cobimetinib Advanced Melanoma · Phase 1 · terminated
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 NCT04658303 (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 Yana Najjar
- Last refreshed: 8 May 2025
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/NCT04658303.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing