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NP-101 (TQ Formula) With Nivolumab and Ipilimumab in Advanced or Metastatic Extra-pulmonary Neuroendocrine Carcinomas
NCT05262556 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG NP-101 (TQ Formula)
- DRUG Nivolumab (3mg/kg)
- DRUG Ipilimumab (1mg/kg)
Study Locations (1)
Ohio
- University hospitals Seidman Cancer Center, Case Comprehensive Cancer Center — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-12-15 |
| Est. Completion | 2026-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05262556
The ClinicalTrials.gov registry entry for NCT05262556 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amr Mohamed MD, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Neuroendocrine Carcinoma appearing as the primary indexed condition, and to 3 interventions — of which NP-101 (TQ Formula) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05262556 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05262556 about?
NCT05262556 is a clinical study titled "NP-101 (TQ Formula) With Nivolumab and Ipilimumab in Advanced or Metastatic Extra-pulmonary Neuroendocrine Carcinomas". 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 h...
What is the current status of trial NCT05262556?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2022-12-15. Estimated completion is 2026-06.
What conditions does trial NCT05262556 study?
This clinical trial studies the following conditions: Neuroendocrine Carcinoma, Gastroenteropancreatic Neuroendocrine Tumor, Gastroenteropancreatic Neuroendocrine Neoplasm, Mixed Neuroendocrine-Non Neuroendocrine Neoplasm. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05262556?
The interventions under investigation include: NP-101 (TQ Formula) (DRUG), Nivolumab (3mg/kg) (DRUG), Ipilimumab (1mg/kg) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05262556?
This trial is sponsored by Amr Mohamed MD, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05262556 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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