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Checkpoint Inhibitor

NP-101 (TQ Formula) + Nivolumab + Ipilimumab for Neuroendocrine Carcinoma

Phase 1
Recruiting
Led By Amr Mohamed, MD
Research Sponsored by Amr Mohamed MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from the start of treatment
Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat a specific type of cancer in people who haven't responded to other treatments.

Who is the study for?
Adults with advanced or metastatic high-grade neuroendocrine carcinomas outside the lungs who have tried at least one treatment without success. They must be in good health otherwise, with normal organ and marrow function, and no unresolved severe side effects from previous treatments. Participants need measurable disease by RECIST criteria, agree to use effective contraception methods if of childbearing potential, and sign a consent form.Check my eligibility
What is being tested?
The trial is testing a combination of NP-101 (TQ Formula), derived from black seed with antioxidant properties, along with two immunotherapy drugs: Nivolumab and Ipilimumab. This second-line therapy aims to assess its effectiveness against tumors that didn't respond to initial treatments.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs due to Nivolumab and Ipilimumab such as inflammation or dysfunction; fatigue; skin issues; hormonal changes; digestive disturbances; increased risk of infections; allergic reactions similar to those caused by compounds related to the study medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from the start of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years from the start of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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
Secondary outcome measures
Safety profile/toxicity of combining NP-101 (TQ Formula) with nivolumab and ipilimumab.
Time to progression (TTP)

Trial Design

1Treatment groups
Experimental Treatment
Group I: NP-101 (TQ Formula) + Nivolumab + IpilimumabExperimental Treatment3 Interventions

Find a Location

Who is running the clinical trial?

Amr Mohamed MDLead Sponsor
Novatek PharmaceuticalsIndustry Sponsor
2 Previous Clinical Trials
368 Total Patients Enrolled
Amr Mohamed, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05262556 — Phase 1
Neuroendocrine Carcinoma Research Study Groups: NP-101 (TQ Formula) + Nivolumab + Ipilimumab
Neuroendocrine Carcinoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT05262556 — Phase 1
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05262556 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still capacity for individuals to join this research project?

"The clinicaltrials.gov record indicates that this medical trial is not actively seeking participants at the current time, with the first post being on November 1st 2022 and last update occurring October 4th 2022. However, there are 226 other investigations currently recruiting patients for their studies."

Answered by AI

Is there a risk to patients when taking TQ Formula (black seed oil capsules)?

"Given the Phase 1 status of this trial, we anticipate that TQ Formula (black seed oil capsules) will only be rated a 1 on the safety scale. This is due to limited data available regarding its safety and effectiveness."

Answered by AI

Is there an opportunity to enroll in the research project?

"To be eligible for this study, individuals must have a certain set of qualifications and fall between the ages of 18 to 80. There is space for around 10 participants in this trial."

Answered by AI

Is geriatric participation welcome in this investigation?

"Based on the parameters of this medical trial, those 18 and older but not yet 80 can apply for enrollment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
NP-101 (TQ Formula) With Nivolumab and Ipilimumab in Advanced or Metastatic Extra-pulmonary Neuroendocrine Carcinomas
Amr Mohamed MD 2022. "NP-101 (TQ Formula) With Nivolumab and Ipilimumab in Advanced or Metastatic Extra-pulmonary Neuroendocrine Carcinomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05262556.
~4 spots leftby Apr 2025
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