drugset / Trial / NCT05262556
NP-101 (TQ Formula) With Nivolumab and Ipilimumab in Advanced or Metastatic Extra-pulmonary Neuroendocrine Carcinomas
NaSingle-groupOpen-labelTreatment
Summary
A pilot study to evaluate the anti-tumor efficacy of this novel combined regimen (NP-101 TQ Formula plus nivolumab and ipilimumab) in the second-line setting for EP-NECA. NP-101 (TQ Formula) (TQ, C10H12O2) is the main bioactive component of the black seed (Nigella sativa, Ranunculaceae family) and has anti-oxidant, anti-angiogenic effects.
Timeline
- Start
- 2022-12-15
- Primary completion
- 2025-12
- Completion
- 2026-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | NP-101 | Traditional medicine (herbal / TCM) | 600 mg | Oral |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |