WHO ICTRP trial
Phase 3 Study of Pembrolizumab and Lenvatinib in Combination with TACE for…
EUCTR2019-002345-37-ES · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2019-002345-37-ES |
|---|---|
| Public title | Phase 3 Study of Pembrolizumab and Lenvatinib in Combination with TACE for Incurable/Non-metastatic Hepatocellular Carcinoma |
| Scientific title | A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) with Pembrolizumab (MK-3475) in Combination with Transarterial Chemoembolization (TACE) Versus TACE in Participants with Incurable/Non-metastatic… |
| Primary sponsor | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Portugal;United States;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;France;Puerto Rico;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic… |
| Conditions | Incurable/Non-metastatic Hepatocellular Carcinoma MedDRA version: 20.0 Level: PT Classification code 10073071 Term: Hepatocellular carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)… |
| Interventions | Product Name: PEMBROLIZUMAB Product Code: MK-3475 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Pembrolizumab CAS Number: 1374853-91-4 Current Sponsor code: MK-3475 Concentration unit: mg/ml milligram(s)/millilitre… |
| Registration date | Jan 23, 2020 |
| Target size | 950 |
| Secondary IDs | MK7902-012 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: