WHO ICTRP trial
A Phase 2/3 (Adaptive Design) Study of the Concomitant Administration of…
EUCTR2017-003634-93-GB · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2017-003634-93-GB |
|---|---|
| Public title | A Phase 2/3 (Adaptive Design) Study of the Concomitant Administration of Indoximod or Placebo plus Pembrolizumab or Nivolumab in Adult Patients with Unresectable Stage III or Stage IV Malignant Melanoma |
| Scientific title | A Phase 2/3 (Adaptive Design) Study of the Concomitant Administration of Indoximod or Placebo plus Pembrolizumab or Nivolumab in Adult Patients with Unresectable Stage III or Stage IV Malignant Melanoma |
| Primary sponsor | NewLink Genetics Corporation |
| 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): yes Therapeutic use (Phase IV): no |
| Countries | France;United States;Canada;Belgium;Australia;Germany;United Kingdom |
| Conditions | Adult Patients with Unresectable Stage III or Stage IV Malignant Melanoma;Therapeutic area: Diseases [C] - Cancer [C04] |
| Interventions | Product Name: Indoximod Pharmaceutical Form: Film-coated tablet INN or Proposed INN: INDOXIMOD Other descriptive name: indoximod, Indoximod Hydrochloride (HCl); 1-methyl-Dtryptophan Concentration unit: mg milligram(s) Concentration type… |
| Registration date | Nov 29, 2017 |
| Target size | 650 |
| Secondary IDs | NLG2107;NCT03301636 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: