WHO ICTRP trial
An open label, randomized, phase 2 study of the anti-Programmed Death-Ligand 1…
EUCTR2016-001688-35-IT · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2016-001688-35-IT |
|---|---|
| Public title | An open label, randomized, phase 2 study of the anti-Programmed Death-Ligand 1 (PD-L1) Durvalumab, alone or in combination with Tremelimumab, in patients with advanced and relapsed germ cell tumors |
| Scientific title | An open label, randomized, phase 2 study of the anti-Programmed Death-Ligand 1 (PD-L1) Durvalumab, alone or in combination with Tremelimumab, in patients with advanced and relapsed germ cell tumors - An open label, randomized, phase 2 study of the anti-Programmed Death-Ligand 1 (PD-L1) Durvalumab, a |
| Primary sponsor | FONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI" |
| 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): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Italy |
| Conditions | Advanced and relapsed germ cell tumors MedDRA version: 21.1 Level: PT Classification code 10068971 Term: Germ cell cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)… |
| Interventions | Product Name: MEDI4736 Product Code: MEDI4736 Pharmaceutical Form: Solution for infusion INN or Proposed INN: durvalumab CAS Number: 1428935-60-7 Current Sponsor code: MEDI4736 Other descriptive name: Durvalumab Concentration unit: mg/ml… |
| Registration date | Jun 17, 2021 |
| Target size | 120 |
| Secondary IDs | APACHE;ISRCTN00000000;NCT00000000 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: