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NCT02600169
Retrospective Analysis of Response Markers and Adverse Events in a Nationwide Cohort of Advanced Melanoma Patients Treated With Pembrolizumab
trial testing Pemprolizumab in Melanoma in 150 participants. Completed in 1 April 2019.
1 April 2019
Quick facts
| Lead sponsor | University Medical Center Groningen |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 150 |
| Start date | 1 July 2015 |
| Primary completion | 1 April 2019 |
| Estimated completion | 1 April 2019 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Pemprolizumab — full drug profile →
Conditions studied
- Melanoma — all drugs for Melanoma →
Sponsor
University Medical Center Groningen
Who can join
18 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Early serum response markers
Time frame: up to day 126
Serum markers: S100B, LDH, white blood count differential neutrophils, monocytes, lymphocytes, eosinophils, basophils. Markers will be correlated to early response as measured by RECIST 1.1 criteria at week 12 and 18 of treatment with pembrolizumab. -
Predicitve patient characteristics
Time frame: baseline
Patient characteristics: age, gender, WHO performance status -
Predictive tumor characteristics
Time frame: baseline
Tumor characteristics: M-stage, presence of CNS metastases, mutation status, PD-L1 status. -
Adverse events of clinical interest will be collected and graded according to the CTCAE version 4.0 criteria
Time frame: 2 years
Sponsor's own description
This study is a retrospective cohort study. A database will be created from the data available of all patients that have participate in the named patient program for pembrolizumab in the Netherlands. This database will be used for analysis of response markers and for an evaluation of adverse events.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02600169
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University Medical Center Groningen trials
Trials by the same sponsor.
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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 NCT02600169 (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 University Medical Center Groningen
- Last refreshed: 3 May 2024
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/NCT02600169.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing