Neuroendocrine Carcinoma / Gastroenteropancreatic Neuroendocrine Neoplasm / NP-101 (TQ Formula) · Phase 1 Trial

NP-101 (TQ Formula) With Nivolumab and Ipilimumab in Advanced or Metastatic Extra-pulmonary Neuroendocrine Carcinomas

ClinicalTrials.gov · August 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 1 pilot trial registered to evaluate antitumor activity of NP-101 (TQ Formula), nivolumab, and ipilimumab in patients with advanced or metastatic extra-pulmonary neuroendocrine carcinomas who progressed on first-line therapy. No results have been posted in this registry record; outcomes remain unreported as of the date provided.

What was studied

Phase 1, Interventional, Single Group, Open label, Treatment purpose. Gastroenteropancreatic Neuroendocrine Tumor, Gastroenteropancreatic Neuroendocrine Neoplasm, Neuroendocrine Carcinoma, Mixed Neuroendocrine-Non Neuroendocrine…; age from 18 Years; to 80 Years. Intervention: NP-101 (TQ Formula) + Nivolumab + Ipilimumab. n = 15. 1 site: United States.

Key findings

Safety

This is a registry record with no results posted; no efficacy, safety, or outcome data are available from this source Phase 1 design means the study is powered for safety and feasibility, not efficacy

Who this may help

This trial is in early phase development. Clinicians should await posting of efficacy and safety results before considering this combination approach for routine use in advanced extra-pulmonary neuroendocrine carcinomas.

Plain-language summary

Phase 1 pilot study with small enrollment (n=15) testing a novel three-drug combination in advanced neuroendocrine carcinoma; no results posted in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Antitumor activity of NP-101 (TQ Formula) plus nivolumab and ipilimumab in subjects with advanced and/or metastatic EP-NECAs who progressed on first line therapy (assessed at Up to 6 months from the start of treatment)

DesignPhase 1, Interventional, Single Group, Open label, Treatment purpose

PopulationGastroenteropancreatic Neuroendocrine Tumor, Gastroenteropancreatic Neuroendocrine Neoplasm, Neuroendocrine Carcinoma, Mixed Neuroendocrine-Non Neuroendocrine…; age from 18 Years; to 80 Years

Sample size15

InterventionNP-101 (TQ Formula) + Nivolumab + Ipilimumab

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment15

Study phasePhase 1

Primary outcome measureAntitumor activity of NP-101 (TQ Formula) plus nivolumab and ipilimumab in subjects with advanced and/or metastatic EP-NECAs who progressed on first line therapy, assessed up to 6 months from start of treatment

Nivolumab dose3 mg/kg

Ipilimumab dose1 mg/kg

Clinical bottom line

Caveats

This is a registry record with no results posted; no efficacy, safety, or outcome data are available from this source
Phase 1 design means the study is powered for safety and feasibility, not efficacy
No comparator arm specified in the registry record
The bioactive component NP-101 (TQ Formula) from Nigella sativa is understudied in oncology; mechanistic rationale relies on in vitro anti-oxidant and anti-angiogenic properties

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 1 interventional pilot design appropriate for safety and feasibility assessment

Directness

strong

Tests combination therapy directly in patients with advanced/metastatic extra-pulmonary neuroendocrine carcinomas

Consistency

insufficient

No comparator arm or prior efficacy data reported in this registry record

Risk of bias

insufficient

Registry record does not report blinding, allocation method, or other bias mitigation details

Sample adequacy

limited

Enrollment of 15 participants typical for Phase 1 but insufficient for efficacy conclusions

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05262556). This is a study registration, not published results. Lead sponsor: Amr Mohamed MD. Recruitment status: COMPLETED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 15 participants (ACTUAL). Conditions: Gastroenteropancreatic Neuroendocrine Tumor, Gastroenteropancreatic Neuroendocrine Neoplasm, Neuroendocrine Carcinoma, Mixed Neuroendocrine-Non Neuroendocrine Neoplasm. Interventions: DRUG: NP-101 (TQ Formula); DRUG: Nivolumab (3mg/kg); DRUG: Ipilimumab (1mg/kg). Primary outcome measures: Antitumor activity of NP-101 (TQ Formula) plus nivolumab and ipilimumab in subjects with advanced and/or metastatic EP-NECAs who progressed on first line therapy , Up to 6 months from the start of treatment. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Neuroendocrine CarcinomaAmr Mohamed MDNCT05262556Gastroenteropancreatic Neuroendocrine NeoplasmNP-101 (TQ Formula)Gastroenteropancreatic Neuroendocrine TumorIpilimumab (1mg/kg)Nivolumab (3mg/kg)