Trials / Active Not Recruiting
Active Not RecruitingNCT05262556
NP-101 (TQ Formula) With Nivolumab and Ipilimumab in Advanced or Metastatic Extra-pulmonary Neuroendocrine Carcinomas
Pilot Study of NP-101 (TQ Formula) in Combination With Nivolumab and Ipilimumab in Advanced and Metastatic Extra-pulmonary Neuroendocrine Carcinomas (EP-NECAs)
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Amr Mohamed MD · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The purpose of this study is to find out if NP-101 (TQ Formula) given with the immunotherapy drugs called nivolumab and ipilimumab helps with neuroendocrine carcinoma who have progressed on at least one first line standard therapy. NP-101 (TQ Formula) black seed oil tablet is an investigational (experimental) drug that may enhance the effect that immunotherapy drugs such as nivolumab and ipilimumab have on neuroendocrine carcinoma.
Conditions
- Gastroenteropancreatic Neuroendocrine Tumor
- Gastroenteropancreatic Neuroendocrine Neoplasm
- Neuroendocrine Carcinoma
- Mixed Neuroendocrine-Non Neuroendocrine Neoplasm
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NP-101 (TQ Formula) | Oral, five 600mg tabs daily every three weeks for four cycles (21-day cycle), then maintenance for an additional 12 weeks for a total of six cycles. |
| DRUG | Nivolumab (3mg/kg) | Intravenously on Day 1 every three weeks for four cycles (maximum dose 360mg once every 3 weeks), then 240mg maintenance every two weeks for six cycles for a total of six months of treatment. |
| DRUG | Ipilimumab (1mg/kg) | Intravenously on day 1 of each (21-day) cycle for a total of four cycles only. |
Timeline
- Start date
- 2022-12-15
- Primary completion
- 2025-12-01
- Completion
- 2026-06-01
- First posted
- 2022-03-02
- Last updated
- 2025-08-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05262556. Inclusion in this directory is not an endorsement.