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Gastroenteropancreatic Neuroendocrine TumorPhase 1NCT05262556

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

A Phase 1 study testing NP-101 (TQ Formula), Nivolumab (3mg/kg) and Ipilimumab (1mg/kg) in people with Gastroenteropancreatic Neuroendocrine Tumor and Gastroenteropancreatic Neuroendocrine Neoplasm, run by Amr Mohamed MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
NP-101 (TQ Formula), Nivolumab (3mg/kg) and Ipilimumab (1mg/kg)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
15 Dec 2022to 27 Oct 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have histologically or cytologically confirmed of relapsed and/or refractory unresectable advanced and/or metastatic high-grade extra-pulmonary neuroendocrine carcinoma (EP-NECAs), and have failed at least one standard line of therapy.
  • Subjects must have received at least one prior therapy for this disease. Subjects must have recovered from acute toxicities of prior chemotherapy. Any prior non-hematologic vital organ toxicity (cardiac, pulmonary, hepatic, and renal) of previous therapy must have resolved to grade 1 or less. Neurological toxicities must have resolved to grade 2 or less.
  • Age >18 years.
  • Subjects must have radiologic disease measurable by RECIST criteria.
  • All previous chemotherapy or radiation must be completed at least three weeks prior to starting study treatment.
  • Performance status ECOG Performance status ≤ 2
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  • Subjects must have normal organ and marrow function as defined below:
  • Hemoglobin ≥ 7.0 g/dl
  • Absolute neutrophil count ≥ 1,500/mcL
  • Platelet count ≥ 75,000/mcL
  • Total bilirubin ≤ 3 X institutional upper limit of normal (except subjects with elevated bilirubin unrelated to liver dysfunction)
  • AST (SGOT) ≤ 2.5 X institutional upper limit of normal
  • ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
  • Serum Creatinine ≤ 1.5 X institutional upper limit of normal
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document.
  • Subjects of childbearing potential must agree to practice reliable contraception or to practice abstinence for at least 28 days before and for 60 days after the last dose of study drug. Reliable contraception is defined as:
  • One highly effective method and one additional effective (barrier) method:
  • Examples of highly effective methods:
  • Intrauterine device (IUD)
  • Hormonal (injections, implants, levonorgestrel-releasing intrauterine system [IUS], medroxyprogesterone acetate depot injections, ovulation inhibitory progesterone-only pills [e.g. desogestrel])
  • Tubal ligation
  • Partner's vasectomy
  • Examples of additional effective methods:
  • Male condom
  • Diaphragm
  • Cervical Cap
  • People of all races and ethnic groups are eligible for this trial.

Who cannot join

  • Well-differentiated GEP-NETs are excluded from this trial.
  • Prior treatment toxicities that have not resolved to ≤ Grade 2 according to NCI CTCAE Version 5.0 (list exceptions, e.g. alopecia, neuropathy, etc).
  • Subjects received prior nivolumab or ipilimumab
  • Subjects with untreated brain metastases/CNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Participants with treated oligometastatic CNS metastases will be considered for the study.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to NP-101 (TQ Formula) or immunotherapy (nivolumab or ipilimumab) used in this study.
  • Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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  • Pregnant or breastfeeding women are excluded from this study because NP-101 (TQ Formula) effects on pregnancy and the fetus used in this protocol is unknown.
  • Known chronic active untreated hepatitis B or C infection.
  • HIV-positive subjects on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with NP-101 (TQ Formula) and immunotherapy agents.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: Pilot Study of NP-101 (TQ Formula) in Combination With Nivolumab and Ipilimumab in Advanced and Metastatic Extra-pulmonary Neuroendocrine Carcinomas (EP-NECAs)

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.

Read the 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.

Being tested
NP-101 (TQ Formula), Nivolumab (3mg/kg), Ipilimumab (1mg/kg)
Keywords
Extrapulmonary Neuroendocrine Carcinoma
Medical subject headings
Gastro-enteropancreatic neuroendocrine tumor, Carcinoma, Neuroendocrine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NP-101 (TQ Formula)Drug

    Also called Black seed oil capsules

    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.

  • Nivolumab (3mg/kg)Drug

    Also called Opdivo

    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.

  • Ipilimumab (1mg/kg)Drug

    Also called Yervoy

    Intravenously on day 1 of each (21-day) cycle for a total of four cycles only.

Study groups in NCT05262556
Study groupRoleWhat they receive
NP-101 (TQ Formula) + Nivolumab + IpilimumabExperimentalNot described
Receives: Drug: NP-101 (TQ Formula); Drug: Nivolumab (3mg/kg); Drug: Ipilimumab (1mg/kg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Antitumor activity will be measured by the number of participants that have a complete response (CR), partial response (PR), or stable disease (SD). CR is defined as the complete disappearance of all target lesions, confirmed by repeat assessments at no less than 4 weeks after the criteria for response is first met. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameter. SD is defined as neither sufficient decrease to qualify for a partial response nor sufficient increase to qualify for progressive disease.

    Measured: Up to 6 months from the start of treatment

Secondary outcomes (2)

  1. Safety profile/toxicity of combining NP-101 (TQ Formula) with nivolumab and ipilimumab.

    Number of participants who experience a Grade 3 or greater drug-related adverse events.

    Measured: Up to 2 years from the start of treatment

  2. Time to progression (TTP)

    To determine the time to progression (TTP) using NP-101 (TQ Formula) plus nivolumab and ipilimumab combined regimen in subjects with EP-NECAs

    Measured: Up to 6 months from the start of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study start15 Dec 2022
  3. Primary completion27 Oct 2025
  4. Study completion27 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05262556
Sponsor's protocol ID
CASE5221
Status last verified
Aug 2026
First submitted
21 Feb 2022
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NP-101 (TQ Formula), Nivolumab (3mg/kg) and Ipilimumab (1mg/kg) in people with Gastroenteropancreatic Neuroendocrine Tumor and Gastroenteropancreatic Neuroendocrine Neoplasm, run by Amr Mohamed MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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 (time frame: Up to 6 months from the start of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05262556.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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